Research MisconductResearch Misconduct

Ayodele S. Jegede, Ayodele S. Jegede, PhD, MHSc.PhD, MHSc.

West African Bioethics Training ProgramWest African Bioethics Training Program

OutlineOutline

ObjectiveObjective Learning outcomeLearning outcome Research misconductResearch misconduct Authorship Authorship Case studyCase study

Objective Objective

To orientate participant to unethical practices in To orientate participant to unethical practices in publication of research findingspublication of research findings

Learning outcomesLearning outcomes

Participant know the criteria for recognizing Participant know the criteria for recognizing research misconductresearch misconduct

Participants able to determine the roles and Participants able to determine the roles and responsibilities of authorsresponsibilities of authors

Research MisconductResearch Misconduct What is it?:What is it?:

Fabrication, falsification, or plagiarism in Fabrication, falsification, or plagiarism in proposingproposing, , performing, or performing, or reviewingreviewing research research results.results. FabricationFabrication:: making up resultsmaking up results and recording or reporting and recording or reporting

themthem FalsificationFalsification:: manipulationmanipulation of research materials, of research materials,

equipment, or processes, or changing or omitting results equipment, or processes, or changing or omitting results such that the research is such that the research is not accurately represented in not accurately represented in the record.the record.

PlagiarismPlagiarism:: the the appropriation of another’sappropriation of another’s ideas, ideas, processes, results, or words without giving proper credit.processes, results, or words without giving proper credit.

Department of Health and Human ServicesDepartment of Health and Human Services

How often does scientific How often does scientific misconduct occur? misconduct occur? There seems to be no consensus on the answer, There seems to be no consensus on the answer,

although a range of estimates were presented although a range of estimates were presented at a conference called last month by a key at a conference called last month by a key federal watchdog agency to announce federal watchdog agency to announce a $1 a $1 million grants program to investigate the million grants program to investigate the prevalence of fraud, data fabrication, prevalence of fraud, data fabrication, plagiarism, and other questionable practices inplagiarism, and other questionable practices in sciencescience. The 8-year-old Office of Research . The 8-year-old Office of Research Integrity hopes to support studies gauging the Integrity hopes to support studies gauging the frequency of misconduct and assessing efforts frequency of misconduct and assessing efforts to raise ethical standards. to raise ethical standards.

ScienceScience 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663 1 December 2000: Vol. 290. no. 5497, pp. 1662 - 1663

• Department of Health & Human Services received Department of Health & Human Services received

267 reports of research misconduct (2004) 267 reports of research misconduct (2004) • 50% increase from 200350% increase from 2003• 35% of closed cases involve research misconduct35% of closed cases involve research misconduct

What is it not:What is it not: Honest error or differences of opinionHonest error or differences of opinion

Criteria Criteria

Represent a Represent a significant departuresignificant departure from from accepted practicesaccepted practices

Have been committed Have been committed intentionallyintentionally, or , or knowinglyknowingly, or , or recklesslyrecklessly; and ; and

Be proven by a preponderance of evidenceBe proven by a preponderance of evidence

What is What is NOT MISCONDUCTNOT MISCONDUCT: : honest, unintentional honest, unintentional errorerror

Top ten “POOR” behaviors [1]Top ten “POOR” behaviors [1]

1. 1. FalsifyingFalsifying or ‘cooking’ research data or ‘cooking’ research data 2. 2. Ignoring major aspects of human-subject Ignoring major aspects of human-subject

requirementsrequirements 3. Not properly disclosing involvement in firms whose 3. Not properly disclosing involvement in firms whose

products are based on one‘s own researchproducts are based on one‘s own research 4. 4. Relationships with students, research subjects or Relationships with students, research subjects or

clients that may be interpreted as questionableclients that may be interpreted as questionable 5. 5. Using another’s ideas without obtaining permission Using another’s ideas without obtaining permission

oror giving due credit (plagiarism)giving due credit (plagiarism)

Top ten behaviors [2]Top ten behaviors [2]

6. Unauthorized use of confidential information in 6. Unauthorized use of confidential information in connection with one’s own researchconnection with one’s own research 7. Failing to present data that contradict one’s own 7. Failing to present data that contradict one’s own previous research previous research ???????? 8. 8. Circumventing certain minor aspects of human-subject Circumventing certain minor aspects of human-subject requirementsrequirements 9. Overlooking others' use of 9. Overlooking others' use of flawed data flawed data or questionable or questionable interpretation of datainterpretation of data 10. 10. Changing the design, methodology or resultsChanging the design, methodology or results of a of a

study in response to pressure from a funding source study in response to pressure from a funding source (falsification)(falsification)

Other BehavioursOther Behaviours

11. Publishing the same data or results in two or more11. Publishing the same data or results in two or more publicationspublications 12. Inappropriately assigning authorship credit12. Inappropriately assigning authorship credit 13. Withholding details of methodology or results in 13. Withholding details of methodology or results in

papers or proposalspapers or proposals 14. Using inadequate or inappropriate research 14. Using inadequate or inappropriate research

designsdesigns 15. Dropping observations or data points from 15. Dropping observations or data points from

analyses based on a gut feeling that they were analyses based on a gut feeling that they were inaccurateinaccurate

16. Inadequate record keeping related to research 16. Inadequate record keeping related to research projectsprojects

Why does misconduct happen?Why does misconduct happen?

Publish or Perish PressurePublish or Perish Pressure Desire to “get ahead”Desire to “get ahead” Personal problemsPersonal problems Character issuesCharacter issues Cultural DifferencesCultural Differences

SCIENTIFIC MISCONDUCT:SCIENTIFIC MISCONDUCT:Scandals Shake Chinese ScienceScandals Shake Chinese Science

““Too many Too many incentivesincentives have blurred the reasons have blurred the reasons for doing science in some people's minds”for doing science in some people's minds” Lu Yongxiang, president of the Chinese Academy of Sciences Lu Yongxiang, president of the Chinese Academy of Sciences

““Though it is difficult to ascertain the number of Though it is difficult to ascertain the number of misconduct cases, the negative impact of these misconduct cases, the negative impact of these cases should not be underestimated”cases should not be underestimated” Ministry of Education spokesperson Wang Xuming Ministry of Education spokesperson Wang Xuming

How is misconduct How is misconduct identifiedidentified

Suspected and reported by a colleagueSuspected and reported by a colleague

Failure to confirm research results Failure to confirm research results

by own lab or othersby own lab or others

Consequences Consequences (if misconduct is (if misconduct is substantiated)substantiated)

Withdrawal or correction of all pending and Withdrawal or correction of all pending and published papers and abstracts affected by the published papers and abstracts affected by the misconductmisconduct

Removal from project, rank and salary Removal from project, rank and salary reduction, dismissalreduction, dismissal

Restitution of funds to the granting agencyRestitution of funds to the granting agency Ineligibility to apply for grants for yearsIneligibility to apply for grants for years End of research career!End of research career!

Researcher Faces Prison for Fraud in NIH Grant Researcher Faces Prison for Fraud in NIH Grant Applications and PapersApplications and Papers ScienceScience 25 March 2005: Vol. 307. no. 5717, p. 1851 25 March 2005: Vol. 307. no. 5717, p. 1851 A researcher formerly at the University of Vermont College of Medicine A researcher formerly at the University of Vermont College of Medicine

has has admitted in court documents to falsifying data in 15 federal grant admitted in court documents to falsifying data in 15 federal grant applications and numerous published articles. applications and numerous published articles.

Eric Poehlman, an expert on menopause, aging, and metabolism, faces Eric Poehlman, an expert on menopause, aging, and metabolism, faces up to 5 years in jail and a $250,000 fine and has been up to 5 years in jail and a $250,000 fine and has been barred for life barred for life from receiving any U.S. research funding. from receiving any U.S. research funding.

The number and scope of falsifications discovered, along with the The number and scope of falsifications discovered, along with the stature of the investigator, are quite remarkable. "stature of the investigator, are quite remarkable. "This is probably one This is probably one of the biggest misconduct cases ever," of the biggest misconduct cases ever,"

Poehlman, 49, first Poehlman, 49, first came under suspicioncame under suspicion in 2000 when in 2000 when Walter DeNino, Walter DeNino, then a 24-year-old research assistant, found inconsistencies in then a 24-year-old research assistant, found inconsistencies in spreadsheetsspreadsheets used in a longitudinal study on aging. used in a longitudinal study on aging.

In an effort to portray worsening health in the subjects, DeNino tells In an effort to portray worsening health in the subjects, DeNino tells ScienceScience, ", "Dr. Poehlman would just switch the data pointsDr. Poehlman would just switch the data points." ."

Who is investigated and who is held Who is investigated and who is held accountable?accountable?

InvestigatedInvestigated All authors that are involved in the specific data in All authors that are involved in the specific data in

questionquestion

Held accountableHeld accountable Primary authorPrimary author Other authors whose results are found culpableOther authors whose results are found culpable The PIThe PI

Mentor ResponsibilitiesMentor Responsibilities

MentorsMentors have the have the responsibilityresponsibility to ensure that all to ensure that all trainees (post-docs, grad students, undergrads) are trainees (post-docs, grad students, undergrads) are awareaware of the of the responsible conduct of researchresponsible conduct of research

Define the RelationshipDefine the Relationship Role of TraineeRole of Trainee Publication/Authorship Publication/Authorship Serving as PI or Co-PIServing as PI or Co-PI

Obligation to reportObligation to report

Good faith reportGood faith report

Scientists behaving badlyScientists behaving badly

““To protect the integrity of science, we must To protect the integrity of science, we must look beyond falsification, fabrication and look beyond falsification, fabrication and

plagiarism, to a wider range of questionable plagiarism, to a wider range of questionable research practices”research practices”

SCIENCE: Vol 435|9, p.737 June 2005 COMMENTARYSCIENCE: Vol 435|9, p.737 June 2005 COMMENTARY

Responsible Research ConductResponsible Research Conduct

• The Office of Research Integrity The Office of Research Integrity (ORI) defines (ORI) defines research integrity research integrity as “as “adherence to rules, adherence to rules, regulations, guidelines, and regulations, guidelines, and commonly accepted professional commonly accepted professional codes or norms.”codes or norms.”

• Research integrity is essential to Research integrity is essential to ensure the ensure the reliabilityreliability of research of research results and to results and to preserve public preserve public supportsupport for research. for research.

PUBLICATION PRACTICES & AUTHORSHIPPUBLICATION PRACTICES & AUTHORSHIP

Publication of results Publication of results fulfills our responsibility to fulfills our responsibility to communicatecommunicate research findings to the scientific research findings to the scientific community. community.

Publication of clinical studies also fulfills our Publication of clinical studies also fulfills our responsibility to have a responsibility to have a scientific benefit scientific benefit in in return for putting human subjects at risk.return for putting human subjects at risk.

Why is publication so important for scientists?Why is publication so important for scientists?

Publications share findings that benefit society Publications share findings that benefit society and promote human healthand promote human health

Publications share findings that benefit society Publications share findings that benefit society and promote human healthand promote human health

Credit for a discovery belongs to the first to Credit for a discovery belongs to the first to publishpublish

Reputations and research funding are based on Reputations and research funding are based on the number and impact of publicationsthe number and impact of publications

Prestigious positions are gained through Prestigious positions are gained through reputation and publicationsreputation and publications

Other than presentations at scientific meetings, Other than presentations at scientific meetings, publication in a scientific journal should publication in a scientific journal should normally be the mechanism for the first public normally be the mechanism for the first public disclosure of new findings. disclosure of new findings.

Why?Why?

[An exception may be appropriate when serious [An exception may be appropriate when serious public health or safety issues are involved.]public health or safety issues are involved.]

AuthorshipAuthorship is: is:

the primary mechanism for determining the the primary mechanism for determining the allocation of credit for scientific advances and allocation of credit for scientific advances and thus the primary basis for assessing a thus the primary basis for assessing a scientist's contributions to developing new scientist's contributions to developing new knowledge. knowledge.

As such, it potentially conveys great benefit, as well as responsibility.

AuthorshipAuthorship involves: involves:

the listing of the names of participants in all the listing of the names of participants in all communications to scientific colleagues (oral or communications to scientific colleagues (oral or written)written)

decisions about who will be the first author, the decisions about who will be the first author, the senior author, and the corresponding authorsenior author, and the corresponding author

Other ways of establishing credit Other ways of establishing credit besides authorship ?besides authorship ?

AcknowledgmentsAcknowledgments - for individuals who have - for individuals who have provided encouragement and advice about the provided encouragement and advice about the study, editorial assistance, technical support, or study, editorial assistance, technical support, or space, financial support, reagents, or space, financial support, reagents, or specimens.specimens.

The use of anyone else’s discoveries, words, The use of anyone else’s discoveries, words, ideas, data, or analyses must be cited in a way ideas, data, or analyses must be cited in a way that others can find the that others can find the referencereference and see the and see the contribution.contribution.

When should authorship issues be When should authorship issues be discussed?discussed?

before and during the course of a study. before and during the course of a study.

when material is to be presented in a public when material is to be presented in a public forum or submitted (originally or in revision) for forum or submitted (originally or in revision) for publication. publication.

Each author should indicate willingness to Each author should indicate willingness to support the general conclusions of the study support the general conclusions of the study before its presentation or submission. before its presentation or submission.

Irresponsible AuthorshipIrresponsible Authorship

Honorary authorshipHonorary authorship - an author who does not meet the criteria- an author who does not meet the criteria

Ghost authorshipGhost authorship - failure to include as an author someone who - failure to include as an author someone who made substantial contributions to the articlemade substantial contributions to the article

Refusal to accept responsibility for an articleRefusal to accept responsibility for an article despite ready acceptance of creditdespite ready acceptance of credit

Duplicate and redundant publicationsDuplicate and redundant publications

Rennie et al, JAMA 280:222, 1998Rennie et al, JAMA 280:222, 1998

Rennie et al’s HypothesisRennie et al’s Hypothesis

Research articles in large-circulation prestigious Research articles in large-circulation prestigious medical journals would be more likely to have medical journals would be more likely to have honorary authorshonorary authors..

Review articles in smaller-circulation journals that Review articles in smaller-circulation journals that publish symposia proceedings would be more publish symposia proceedings would be more likely to have likely to have ghost authors.ghost authors.

Rennie et al, JAMA 280:222, 1998Rennie et al, JAMA 280:222, 1998

Research articlesResearch articles ReviewsReviews

HonoraryHonorary 79 (16%) 79 (16%) 61 (26%)61 (26%)

GhostGhost 65 (13%) 65 (13%) 23 (10%)23 (10%)

The corresponding authors of 492 research articles The corresponding authors of 492 research articles and 240 reviews in: Amer J Cardiology, and 240 reviews in: Amer J Cardiology, Amer J Medicine, Amer J ObGyn, Annals Internal Amer J Medicine, Amer J ObGyn, Annals Internal Medicine, JAMA, and NEJM were surveyed.Medicine, JAMA, and NEJM were surveyed.

Rennie et al, JAMA 280:222, 1998Rennie et al, JAMA 280:222, 1998

Authorship AnalysisAuthorship Analysis

Annals of Internal MedicineAnnals of Internal Medicine Authorship CriteriaAuthorship Criteria

Authors should meet Authors should meet allall of these criteria: of these criteria:

Conceived and planned the work, Conceived and planned the work, or interpreted the evidence it presents, or bothor interpreted the evidence it presents, or both

Wrote the paper, or reviewed successiveWrote the paper, or reviewed successive versions and took part in the revision processversions and took part in the revision process

Approved the final versionApproved the final version

What is missing from this list?What is missing from this list?

Annals of Internal MedicineAnnals of Internal Medicine Authorship CriteriaAuthorship Criteria

The following, by themselves, are not criteria The following, by themselves, are not criteria for authorship:for authorship:

o holding position of administrative leadershipholding position of administrative leadership

o contributing patients or reagentscontributing patients or reagents

o collecting and assembling datacollecting and assembling data

Case Study

Dr. Colleen May is a participating neurologist in

a clinical trial to assess the efficacy and toxicity of

a new anticonvulsant medication.

For the duration of the 2-year study, each

neurologist is to meet with each of his/her patients

for an average of 30 minutes per month.

In Dr. May’s case, this amounts to an average of

20 hours per month.

.

During each visit, the physicians administer a

variety of specialized tests, requiring judgments

dependent on their experience and training in

neurology.

At the completion of the study,the results are to

be unblinded and analyzed by the project

leaders.

It is anticipated that at least two publications will

be prepared for the New England Journal of

Medicine.

Dr. May has just learned that she will be listed

in the Acknowledgements, but not as a coauthor

of the manuscript.

Dr. May argues that she has provided nearly

500 hours of her expert time, far more than

needed to complete a publishable study in her

experimental lab.

Does Dr. May have a case for authorship?

acknowledgementacknowledgement

Dr. Thomas Inzana, Associate Vice President for Research Dr. Thomas Inzana, Associate Vice President for Research Programs, Office of the Vice President for ResearchPrograms, Office of the Vice President for Research

tinzana@vt.edutinzana@vt.edu

Guidelines for the Conduct of Research in the Intramural Guidelines for the Conduct of Research in the Intramural Research Program at NIH Research Program at NIH http://www.nih.gov/campus/irnews/guidelines.htmhttp://www.nih.gov/campus/irnews/guidelines.htm

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