RELATIONSHIPS WITH THE ALCOHOLIC RELATIONSHIPS WITH THE ALCOHOLIC

BEVERAGE INDUSTRYBEVERAGE INDUSTRY

PHARMACEUTICAL COMPANIES AND PHARMACEUTICAL COMPANIES AND

OTHER FUNDING AGENCIESOTHER FUNDING AGENCIES

HOLY GRAIL OR POISONED CHALICEHOLY GRAIL OR POISONED CHALICE

Peter Miller12

Thomas F Babor3

1Deakin University Geelong Australia2Commissioning Editor Addiction3Associate Editor-in-chief Addiction

ldquoldquoIt is the job of science to advise to It is the job of science to advise to be helpful to and to support the be helpful to and to support the

policy process but its inalienable policy process but its inalienable responsibility is also to criticise responsibility is also to criticise question test and be awkward question test and be awkward

Science has to have a larger vision Science has to have a larger vision of itself than its being merely a of itself than its being merely a biddable management toolrdquo biddable management toolrdquo

(Edwards 1993 13)

Two main reasonsTwo main reasons

1) Keeping true to the ideal of sciencendash essential for the field

sustaining public trust ensuring that the field moves towards the most effective interventions available

2) Adhering to the ethical principle of beneficence (the obligation to maximise possible benefits and minimise possible harms) ndash equally important when considering whether research

could truly be said to be in the best interests of the research participants

Types of Adverse InfluenceTypes of Adverse Influence

Direct censorshipDirect censorship

Non publicationNon publication

Limited accessLimited access

Project fundingProject funding

Inadequate Inadequate

inappropriate inappropriate

researchersresearchers

Source Gruning et al 2006

Suppression Suppression

Dilution Dilution

DistractionDistraction

ConcealmentConcealment

ManipulationManipulation

Source Miller et al 2006

Sources of influenceSources of influence

Tobacco industryAlcohol industryPharmaceutical industryGambling industryGovernment agenciesOther funding bodiesOther interest groupsOur own biases

Alcohol and Tobacco IndustriesDirect support to Centres and investigators to conduct research ndash (eg Philip Morris funding to develop ldquosafer cigarettesrdquo or DIAGEO

funding to investigate the ldquodriversrdquo of binge drinking)Indirect support from Trade Associations or Social Aspects Organizations to conduct surveys or write book chapters ndash (eg International Centre for Alcohol Policy)

Direct support to Universities for investigatorsrsquo salaries and centre endowments ndash (eg Ernest Gallo Clinic and Research Center at the University of California)

Indirect support from ldquoindependentrdquo research funding organizations ndash (eg alcohol and tobacco companies set up organizations that give

research grants to young investigators ndash European Research Advisory Board (ERAB) Alcoholic Beverage Medical Research Foundation (ABMRF) Drinkwise (Australia)

Direct contract research ndash (eg do an analysis of the literature conduct a survey study the

ldquotasterdquo qualities of cigarettes or alcohol

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

ldquoldquoIt is the job of science to advise to It is the job of science to advise to be helpful to and to support the be helpful to and to support the

policy process but its inalienable policy process but its inalienable responsibility is also to criticise responsibility is also to criticise question test and be awkward question test and be awkward

Science has to have a larger vision Science has to have a larger vision of itself than its being merely a of itself than its being merely a biddable management toolrdquo biddable management toolrdquo

(Edwards 1993 13)

Two main reasonsTwo main reasons

1) Keeping true to the ideal of sciencendash essential for the field

sustaining public trust ensuring that the field moves towards the most effective interventions available

2) Adhering to the ethical principle of beneficence (the obligation to maximise possible benefits and minimise possible harms) ndash equally important when considering whether research

could truly be said to be in the best interests of the research participants

Types of Adverse InfluenceTypes of Adverse Influence

Direct censorshipDirect censorship

Non publicationNon publication

Limited accessLimited access

Project fundingProject funding

Inadequate Inadequate

inappropriate inappropriate

researchersresearchers

Source Gruning et al 2006

Suppression Suppression

Dilution Dilution

DistractionDistraction

ConcealmentConcealment

ManipulationManipulation

Source Miller et al 2006

Sources of influenceSources of influence

Tobacco industryAlcohol industryPharmaceutical industryGambling industryGovernment agenciesOther funding bodiesOther interest groupsOur own biases

Alcohol and Tobacco IndustriesDirect support to Centres and investigators to conduct research ndash (eg Philip Morris funding to develop ldquosafer cigarettesrdquo or DIAGEO

funding to investigate the ldquodriversrdquo of binge drinking)Indirect support from Trade Associations or Social Aspects Organizations to conduct surveys or write book chapters ndash (eg International Centre for Alcohol Policy)

Direct support to Universities for investigatorsrsquo salaries and centre endowments ndash (eg Ernest Gallo Clinic and Research Center at the University of California)

Indirect support from ldquoindependentrdquo research funding organizations ndash (eg alcohol and tobacco companies set up organizations that give

research grants to young investigators ndash European Research Advisory Board (ERAB) Alcoholic Beverage Medical Research Foundation (ABMRF) Drinkwise (Australia)

Direct contract research ndash (eg do an analysis of the literature conduct a survey study the

ldquotasterdquo qualities of cigarettes or alcohol

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Two main reasonsTwo main reasons

1) Keeping true to the ideal of sciencendash essential for the field

sustaining public trust ensuring that the field moves towards the most effective interventions available

2) Adhering to the ethical principle of beneficence (the obligation to maximise possible benefits and minimise possible harms) ndash equally important when considering whether research

could truly be said to be in the best interests of the research participants

Types of Adverse InfluenceTypes of Adverse Influence

Direct censorshipDirect censorship

Non publicationNon publication

Limited accessLimited access

Project fundingProject funding

Inadequate Inadequate

inappropriate inappropriate

researchersresearchers

Source Gruning et al 2006

Suppression Suppression

Dilution Dilution

DistractionDistraction

ConcealmentConcealment

ManipulationManipulation

Source Miller et al 2006

Sources of influenceSources of influence

Tobacco industryAlcohol industryPharmaceutical industryGambling industryGovernment agenciesOther funding bodiesOther interest groupsOur own biases

Alcohol and Tobacco IndustriesDirect support to Centres and investigators to conduct research ndash (eg Philip Morris funding to develop ldquosafer cigarettesrdquo or DIAGEO

funding to investigate the ldquodriversrdquo of binge drinking)Indirect support from Trade Associations or Social Aspects Organizations to conduct surveys or write book chapters ndash (eg International Centre for Alcohol Policy)

Direct support to Universities for investigatorsrsquo salaries and centre endowments ndash (eg Ernest Gallo Clinic and Research Center at the University of California)

Indirect support from ldquoindependentrdquo research funding organizations ndash (eg alcohol and tobacco companies set up organizations that give

research grants to young investigators ndash European Research Advisory Board (ERAB) Alcoholic Beverage Medical Research Foundation (ABMRF) Drinkwise (Australia)

Direct contract research ndash (eg do an analysis of the literature conduct a survey study the

ldquotasterdquo qualities of cigarettes or alcohol

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Types of Adverse InfluenceTypes of Adverse Influence

Direct censorshipDirect censorship

Non publicationNon publication

Limited accessLimited access

Project fundingProject funding

Inadequate Inadequate

inappropriate inappropriate

researchersresearchers

Source Gruning et al 2006

Suppression Suppression

Dilution Dilution

DistractionDistraction

ConcealmentConcealment

ManipulationManipulation

Source Miller et al 2006

Sources of influenceSources of influence

Tobacco industryAlcohol industryPharmaceutical industryGambling industryGovernment agenciesOther funding bodiesOther interest groupsOur own biases

Alcohol and Tobacco IndustriesDirect support to Centres and investigators to conduct research ndash (eg Philip Morris funding to develop ldquosafer cigarettesrdquo or DIAGEO

funding to investigate the ldquodriversrdquo of binge drinking)Indirect support from Trade Associations or Social Aspects Organizations to conduct surveys or write book chapters ndash (eg International Centre for Alcohol Policy)

Direct support to Universities for investigatorsrsquo salaries and centre endowments ndash (eg Ernest Gallo Clinic and Research Center at the University of California)

Indirect support from ldquoindependentrdquo research funding organizations ndash (eg alcohol and tobacco companies set up organizations that give

research grants to young investigators ndash European Research Advisory Board (ERAB) Alcoholic Beverage Medical Research Foundation (ABMRF) Drinkwise (Australia)

Direct contract research ndash (eg do an analysis of the literature conduct a survey study the

ldquotasterdquo qualities of cigarettes or alcohol

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Sources of influenceSources of influence

Tobacco industryAlcohol industryPharmaceutical industryGambling industryGovernment agenciesOther funding bodiesOther interest groupsOur own biases

Alcohol and Tobacco IndustriesDirect support to Centres and investigators to conduct research ndash (eg Philip Morris funding to develop ldquosafer cigarettesrdquo or DIAGEO

funding to investigate the ldquodriversrdquo of binge drinking)Indirect support from Trade Associations or Social Aspects Organizations to conduct surveys or write book chapters ndash (eg International Centre for Alcohol Policy)

Direct support to Universities for investigatorsrsquo salaries and centre endowments ndash (eg Ernest Gallo Clinic and Research Center at the University of California)

Indirect support from ldquoindependentrdquo research funding organizations ndash (eg alcohol and tobacco companies set up organizations that give

research grants to young investigators ndash European Research Advisory Board (ERAB) Alcoholic Beverage Medical Research Foundation (ABMRF) Drinkwise (Australia)

Direct contract research ndash (eg do an analysis of the literature conduct a survey study the

ldquotasterdquo qualities of cigarettes or alcohol

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Alcohol and Tobacco IndustriesDirect support to Centres and investigators to conduct research ndash (eg Philip Morris funding to develop ldquosafer cigarettesrdquo or DIAGEO

funding to investigate the ldquodriversrdquo of binge drinking)Indirect support from Trade Associations or Social Aspects Organizations to conduct surveys or write book chapters ndash (eg International Centre for Alcohol Policy)

Direct support to Universities for investigatorsrsquo salaries and centre endowments ndash (eg Ernest Gallo Clinic and Research Center at the University of California)

Indirect support from ldquoindependentrdquo research funding organizations ndash (eg alcohol and tobacco companies set up organizations that give

research grants to young investigators ndash European Research Advisory Board (ERAB) Alcoholic Beverage Medical Research Foundation (ABMRF) Drinkwise (Australia)

Direct contract research ndash (eg do an analysis of the literature conduct a survey study the

ldquotasterdquo qualities of cigarettes or alcohol

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Pharmaceutical IndustryPharmaceutical Industry

Huge investment in psychoactive medications Huge investment in psychoactive medications development (eg pain sleep anxiety etc ) development (eg pain sleep anxiety etc ) and in pharmacological cures for addiction (eg and in pharmacological cures for addiction (eg naltrexone methadone etc)naltrexone methadone etc)Direct contracting of university faculty and Direct contracting of university faculty and contract research organizations for clinical trialscontract research organizations for clinical trialsOften control research design medication dose Often control research design medication dose data analyses publication processdata analyses publication processEvidence suggests that studies funded by drug Evidence suggests that studies funded by drug companies are more likely to produce positive companies are more likely to produce positive findings (eg Friedman and Richter 2004)findings (eg Friedman and Richter 2004)

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Government agencies

pursuit of scientific truth detached from the practical pursuit of scientific truth detached from the practical interests of everyday life ought to be treated as interests of everyday life ought to be treated as sacred by every government and it is in the sacred by every government and it is in the highest interests of all that honest servants of truth highest interests of all that honest servants of truth should be left in peace should be left in peace Albert Einstein (1934)Albert Einstein (1934)

Globally one of the biggest offendersGlobally one of the biggest offenders

Types of research fundednot fundedTypes of research fundednot fundedCensorshipCensorship

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Other interest groupsOur own biasProfessional associations (such as medical societies) Professional associations (such as medical societies) ndash Traditionally have sought to maintain or increase their influence Traditionally have sought to maintain or increase their influence ndash Each discipline produces its own literature base Each discipline produces its own literature base ndash Size and complexity of this literature base helps to determine differential Size and complexity of this literature base helps to determine differential

power structures within treatment settings power structures within treatment settings Religious organisationsReligious organisationsFellowship groups - may influence research findings through non-Fellowship groups - may influence research findings through non-participation participation Service providersService providersndash derive their income (and some of their raison decirctre) from treating addiction derive their income (and some of their raison decirctre) from treating addiction ndash political and economic weight of mantras such as lsquotreatment worksrsquo political and economic weight of mantras such as lsquotreatment worksrsquo ndash pragmatic needs of governments and service providers pragmatic needs of governments and service providers ndash invested both financially and existentially in the perceived success of the invested both financially and existentially in the perceived success of the

treatment they provide treatment they provide Personal Conflicts of InterestPersonal Conflicts of Interestndash Religious beliefsReligious beliefs

for the benefit of a secular readership in articles concerning religion and medicine in the Journal the Editor should require the authors religious position to be stated under competing interests (Clarke 2007 422)

ndash Personal investmentDisciplinary training self worth financial security lsquolegacyrsquo

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Who can actWho can act

Academic journalsAcademic journalsndash Author statements outing authorsfunders editorialsAuthor statements outing authorsfunders editorials

InstitutionsInstitutionsndash Ethical guidelines training Ethical guidelines training

Professional societiesProfessional societiesndash Codes of conduct awareness raisingCodes of conduct awareness raising

Individual academicsIndividual academicsndash lsquolsquoOutingrsquo funders (PERIL analysis)Outingrsquo funders (PERIL analysis)

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

ldquoldquoA submitted manuscript is the A submitted manuscript is the intellectual property of its authors intellectual property of its authors not the study sponsor We will not not the study sponsor We will not review or publish articles based on review or publish articles based on studies that are conducted under studies that are conducted under

conditions that allow the sponsor to conditions that allow the sponsor to have sole control of the data or to have sole control of the data or to

withhold publicationrdquowithhold publicationrdquo(Davidoff et al 2001b 463 - Editor Emeritus Annals of Internal Medicine )

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Conflict of interest statementsConflict of interest statementsDrug and Alcohol DependenceDrug and Alcohol Dependencendash 101 Role of Funding Source101 Role of Funding Source

eg Funding for this study was provided by NIMH Grant XXXXXXX the eg Funding for this study was provided by NIMH Grant XXXXXXX the NIMH had no further role in study design in the collection analysis and NIMH had no further role in study design in the collection analysis and interpretation of data in the writing of the report or in the decision to interpretation of data in the writing of the report or in the decision to submit the paper for publicationsubmit the paper for publication

102) Contributors102) Contributors eg Authors X and Y designed the study and wrote the protocol Author Z eg Authors X and Y designed the study and wrote the protocol Author Z managed the literature searches and summaries of previous related managed the literature searches and summaries of previous related workwork

103)103) Conflict of InterestConflict of Interest ALL authors are requested to disclose any ALL authors are requested to disclose any actual or potential conflict of interest including any financial personal or actual or potential conflict of interest including any financial personal or other relationships with other people or organizations within three (3) other relationships with other people or organizations within three (3) years of beginning the work submitted that could inappropriately years of beginning the work submitted that could inappropriately influence or be perceived to influence their workinfluence or be perceived to influence their work

eg Author Y owns shares in pharma company A Author X and Z have eg Author Y owns shares in pharma company A Author X and Z have consulted for pharma company B All other authors declare that they consulted for pharma company B All other authors declare that they have no conflicts of interesthave no conflicts of interest

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

InstitutionsInstitutionsa growing number of universities have refused to accept funding from the tobacco industry some research centres have developed their own internal policiesinstitutional ethics review boards to assess the appropriateness of funder-researcher relationships

Eg IFT Requests to conduct research will only be accepted if1 the question is formulated globally and is undirected (eg the extent of drug abuse in

the population) and not biased (eg the study is expected to demonstrate that a certain behaviour bears no risk for the population)

2 the research question is scientifically relevant and 3 the free and unrestricted further design of the study is guaranteed by the contract1048698 Further

guaranteed independent formulation of the research objectives hypotheses and the study methodologyunrestricted statistical analysis interpretation and publication of results funds must be granted to the IFT as unrestricted educational grants or donationsdo not accept funding of research projects by the tobacco industry A single funding source must not contribute to more than 10 of the annual budgetall industry funds should not exceed 20

Institut fuer Therapieforschung - Munich Germany

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Professional SocietiesProfessional SocietiesGuidelines for the behaviour of acceptable funding bodies conflicts of Guidelines for the behaviour of acceptable funding bodies conflicts of interest and related issues interest and related issues

Federation of American Societies for Experimental Biology (FASEB Federation of American Societies for Experimental Biology (FASEB 2007) has issued a call to the scientific community to adopt more 2007) has issued a call to the scientific community to adopt more consistent policies and practices for disclosing and managing financial consistent policies and practices for disclosing and managing financial relationships between academia and industry in biomedical research relationships between academia and industry in biomedical research

The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi The FASEB Toolkit (see httpopafaseborgpagesAdvocacycoi Toolkithtm) Toolkithtm) ndash set of model guidelines that speak specifically to institutions that develop and set of model guidelines that speak specifically to institutions that develop and

enforce policies for their investigators editors who develop disclosure policies for enforce policies for their investigators editors who develop disclosure policies for authors and scientific and professional societies that have a role in promoting authors and scientific and professional societies that have a role in promoting professional ethics professional ethics

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Individual Individual authorsauthors

Remains in large part the responsibility of individual Remains in large part the responsibility of individual authorsauthorsndash limited ability to understand or act upon the complex ethical limited ability to understand or act upon the complex ethical

political clinical and scientific issues political clinical and scientific issues

ButButmost addiction scientists have chosen to eliminate most addiction scientists have chosen to eliminate themselves from participation in activities with obvious themselves from participation in activities with obvious conflicts of interestconflicts of interest

Nevertheless what is needed is a more systemic set of Nevertheless what is needed is a more systemic set of procedures that allow individuals to conduct a risk procedures that allow individuals to conduct a risk analysis of different funding opportunitiesanalysis of different funding opportunities

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

PERIL - PERIL - Adams (2007)Adams (2007)

Purpose Purpose ndash Are the purposes of the funding and recipient organizations divergent or Are the purposes of the funding and recipient organizations divergent or

consistent consistent Extent Extent ndash To what extent does the recipient rely on this source of funding To what extent does the recipient rely on this source of funding ndash As the proportion of income increases it becomes more difficult to As the proportion of income increases it becomes more difficult to

separate from the sourcersquos expectations separate from the sourcersquos expectations Relevant harm Relevant harm ndash What is the harm associated with the product or service provided by the What is the harm associated with the product or service provided by the

organization organization IdentifiedIdentifiedndash Does the funding organization benefit from being identified with the Does the funding organization benefit from being identified with the

researcherrsquos reputation or organization researcherrsquos reputation or organization ndash Is there a visible association with public good activities for the purposes Is there a visible association with public good activities for the purposes

of positive branding Can this be used for political or commercial of positive branding Can this be used for political or commercial purposes purposes

Link Link ndash What is the Link between funder and researcher The more direct the What is the Link between funder and researcher The more direct the

link the stronger the influence and the more visible the associationlink the stronger the influence and the more visible the association

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Eg Eg A FUNDING OPPORTUNITY FROM A FUNDING OPPORTUNITY FROM PHILLIP MORRISPHILLIP MORRIS

A university-based School of Medicine distributes an email announcing to all A university-based School of Medicine distributes an email announcing to all

faculty and staff the availability of a new research funding opportunity The faculty and staff the availability of a new research funding opportunity The

announcement reads ldquoPlease see the link below for an available funding announcement reads ldquoPlease see the link below for an available funding

opportunity from the Philip Morris External Research Foundation opportunity from the Philip Morris External Research Foundation

(httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website (httpresadmuchceduorspfundingopps2007 RFApdf)rdquo The website

invites scientists to submit funding proposals to Philip Morris independent invites scientists to submit funding proposals to Philip Morris independent

peer reviewed external research programme which is willing to support peer reviewed external research programme which is willing to support

research on the disease mechanisms and health endpoints of tobacco research on the disease mechanisms and health endpoints of tobacco

smoking and smoke exposure The programmes Scientific Advisory Board smoking and smoke exposure The programmes Scientific Advisory Board

Members are listed on one of the pages of the Request for Applications Members are listed on one of the pages of the Request for Applications

(RFA) an impressive looking group of academics including department (RFA) an impressive looking group of academics including department

chairs distinguished professors and even the President of the Hungarian chairs distinguished professors and even the President of the Hungarian

Academy of Sciences Academy of Sciences

Should you apply for the funds

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

PERIL analysis case illustration 1PERIL analysis case illustration 1Is the Is the purpose purpose of your academic institution consistent with the stated purpose of Phillip Morris of your academic institution consistent with the stated purpose of Phillip Morris Purposes are incompatible Purposes are incompatible Anti-scientific record of Phillip Morris Anti-scientific record of Phillip Morris

What about the What about the extent extent of the funding of the funding Accepting funding from a tobacco company could jeopardise money from other sources Accepting funding from a tobacco company could jeopardise money from other sources This could create a dependence on tobacco money when other sources of funding become more scarceThis could create a dependence on tobacco money when other sources of funding become more scarce

Is there Is there relevant harm relevant harm associated with Phillip Morriss continued marketing of tobacco productsassociated with Phillip Morriss continued marketing of tobacco products The evidence is incontrovertibleThe evidence is incontrovertible

Will the recipient of the funds be Will the recipient of the funds be identified identified with the funder so that Phillip Morris might benefit from with the funder so that Phillip Morris might benefit from its support of university-based scientists And could funded scientists eventually be exposed to its support of university-based scientists And could funded scientists eventually be exposed to reputational risk if their names were associated with Phillip Morris reputational risk if their names were associated with Phillip Morris

The answer is a possible yes to both questions The answer is a possible yes to both questions

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on In this case it is indirect so it may not involve a major conflict of interest and there are no limitations on

publication imposed by the funderpublication imposed by the funder

In summary the analysis indicates that there are incompatible institutional interests a potential for In summary the analysis indicates that there are incompatible institutional interests a potential for developing dependence on an industry funding source relevant harms to the public if tobacco sales developing dependence on an industry funding source relevant harms to the public if tobacco sales continue as more research is conducted a potential for future reputational risk and a possible political continue as more research is conducted a potential for future reputational risk and a possible political benefit for Phillip Morrisbenefit for Phillip Morris

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

PERIL analysis case illustration 2PERIL analysis case illustration 2A residential rehabilitation charity approaches you to collaborate in an A residential rehabilitation charity approaches you to collaborate in an

application to fund doctoral research into the long-term application to fund doctoral research into the long-term effectiveness of its project The charity reports that it has been effectiveness of its project The charity reports that it has been involved in research previously and has found it beneficial The involved in research previously and has found it beneficial The methodology is discussed and agreed The application is designed methodology is discussed and agreed The application is designed to go to a government funding body which provides match funding to go to a government funding body which provides match funding for collaborations between community organisations and for collaborations between community organisations and universities The charity expresses concern about the confidentiality universities The charity expresses concern about the confidentiality of its service users and requests that We would however want the of its service users and requests that We would however want the research findings to be kept confidential except in so far as they are research findings to be kept confidential except in so far as they are needed to fulfill the requirements for the degree Subsequent needed to fulfill the requirements for the degree Subsequent investigation shows that while the charity refers to a strong research investigation shows that while the charity refers to a strong research pedigree findings have only been published in non peer-reviewed pedigree findings have only been published in non peer-reviewed trade magazines or internal reportstrade magazines or internal reports

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Is the Is the purpose purpose of your academic institution consistent with the stated purpose of the charity of your academic institution consistent with the stated purpose of the charity At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though At first glance it would appear that the charity has the laudable goal of assessing its effectiveness though independent research independent research desire to control dissemination (presumably in case of unfavourable findings) desire to control dissemination (presumably in case of unfavourable findings) previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be previous track record of publishing only in non peer-reviewed journals would suggest that its goal might not be excellence excellence

What about the What about the extent extent of the funding of the funding In this example this is unlikely to be a major factor as the amount involved would be comparatively smallIn this example this is unlikely to be a major factor as the amount involved would be comparatively small

Is there Is there relevant harmrelevant harm Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Some harm in this case if the findings are unfavourable and the charity chooses not to disseminate the report Charity providing ineffective treatment and using resources that might be better used elsewhere Charity providing ineffective treatment and using resources that might be better used elsewhere Skewing the knowledge base through omission of negative findingsSkewing the knowledge base through omission of negative findings

Will the researchers and university be Will the researchers and university be identified identified with the evaluationwith the evaluationIt is within the interest of the charity to point to the fact that the research was conducted independently It is within the interest of the charity to point to the fact that the research was conducted independently

Finally is the nature of the Finally is the nature of the link link between recipient and donor direct or indirect between recipient and donor direct or indirect It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by It is indirect so it may not involve a major conflict of interest and there are no limitations on publication imposed by the funderthe funder

In this case it would be possible for the researchers or the university to insist that the charity remove its right to control In this case it would be possible for the researchers or the university to insist that the charity remove its right to control release of the data If that were done the PERIL analysis would suggest that the funding is worth pursuingrelease of the data If that were done the PERIL analysis would suggest that the funding is worth pursuing

PERIL analysisPERIL analysis

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

SummarySummaryEvery individual discipline and funding organisation brings its own agenda to the Every individual discipline and funding organisation brings its own agenda to the

research process research process ndash conundrums associated with research funding are becoming increasingly complex conundrums associated with research funding are becoming increasingly complex ndash research plays a greater role in the regulation and marketing of potentially addictive productsresearch plays a greater role in the regulation and marketing of potentially addictive productsndash Much greater pressure on academics to attract research fundingMuch greater pressure on academics to attract research funding

Addiction scientists should be vigilant about Addiction scientists should be vigilant about anyany funding source funding sourcendash restrictions on the design interpretation and publication of the resulting data restrictions on the design interpretation and publication of the resulting data ndash Consulting arrangements Consulting arrangements ndash Acceptance of fees for writing book chapters Acceptance of fees for writing book chapters ndash preparing background reports preparing background reports ndash attending industry-organized conferences attending industry-organized conferences ndash writing letters to the editor writing letters to the editor

Before accepting funding addiction scientists should carefully considerBefore accepting funding addiction scientists should carefully considerHow much is the scientific activity designed to promote the interests of a particular industryHow much is the scientific activity designed to promote the interests of a particular industryWill the funding source be acknowledgedWill the funding source be acknowledged

Funding obtained from any source can be legitimate Major issues to considerFunding obtained from any source can be legitimate Major issues to considerndash consistent with scientific and public health aimsconsistent with scientific and public health aimsndash grant review process independent transparent and peer reviewedgrant review process independent transparent and peer reviewedndash the funding source does not impose rigid limits on the types of research to be conducted the funding source does not impose rigid limits on the types of research to be conducted

Examine all funding sources using PERIL analysis (or similar framework)Examine all funding sources using PERIL analysis (or similar framework)

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187

Thank youThank youReferencesReferencesndash Adams P J (2007) Assessing whether to receive funding Adams P J (2007) Assessing whether to receive funding

support from tobacco alcohol gambling and other support from tobacco alcohol gambling and other dangerous consumption industries dangerous consumption industries Addiction 102Addiction 102(7) 1027-(7) 1027-10331033

ndash Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards G (1993) Substance Misuse and the Uses of Science In G Edwards J Strang amp J H Jaffe (Eds) Edwards J Strang amp J H Jaffe (Eds) Drugs Alcohol and Tobacco Drugs Alcohol and Tobacco Making the Science and Policy ConnectionsMaking the Science and Policy Connections (pp 3-16) Oxford Oxford (pp 3-16) Oxford Oxford University PressUniversity Press

ndash Hall W (2006) Ensuring that addiction science is deserving of public Hall W (2006) Ensuring that addiction science is deserving of public trust trust Addiction 101Addiction 101(9) 1223-1224(9) 1223-1224

ndash International Committee of Medical Journal Editors (2005) International Committee of Medical Journal Editors (2005) Ethical Ethical Practice Guidelines in Addiction PublishingPractice Guidelines in Addiction Publishing httpwwwisajenet httpwwwisajenet (accessed 14 April 2006)(accessed 14 April 2006)

ndash Miller P Moore D amp Strang J (2006) The regulation of research by Miller P Moore D amp Strang J (2006) The regulation of research by funding bodies An emerging ethical issue for the alcohol and other drug funding bodies An emerging ethical issue for the alcohol and other drug sector sector International Journal of Drug Policy 17International Journal of Drug Policy 17(1) 12-16(1) 12-16

ndash Room R (1993) The evolution of alcohol monopolies and their Room R (1993) The evolution of alcohol monopolies and their relevance for public health relevance for public health Contemporary Drug ProblemsContemporary Drug Problems 20(2) p169- 20(2) p169-187187