RESEARCH ETHICSRESEARCH ETHICS

Dr Deepthi EdussuriyaDr Deepthi Edussuriya

OBJECTIVESOBJECTIVES Discuss what is meant by and why there Discuss what is meant by and why there

should be ethical standards in Bio should be ethical standards in Bio Medical researchMedical research

Identify ethical issues in Bio Medical Identify ethical issues in Bio Medical research which would amount to research which would amount to scientific misconductscientific misconduct

Explain the role of an ethics review Explain the role of an ethics review committee committee

Construct a set of guidelines for Construct a set of guidelines for members of ethics review committees members of ethics review committees

Research Ethics…..Research Ethics…..

Involves the application of Involves the application of fundamental fundamental ethical principles ethical principles to to planningplanning, , conductingconducting & & publishingpublishing of research of research

Guiding principlesGuiding principles

Autonomy and respectAutonomy and respect BeneficenceBeneficence Non-maleficenceNon-maleficence Justice ( free from exploitation)Justice ( free from exploitation) Scientific validityScientific validity HonestyHonesty

Student activityStudent activity

Identify ethical issues in the Identify ethical issues in the following scenariosfollowing scenarios

Group 1Group 1

Two graduate students have made some Two graduate students have made some measurements on a new material. The data measurements on a new material. The data points are as shown. To prove their points are as shown. To prove their hypothesis the results should lie on the hypothesis the results should lie on the curve shown. The two students considered curve shown. The two students considered omitting the two data points which were off omitting the two data points which were off the theoretical curve.the theoretical curve.

Unethical as it would amount to Unethical as it would amount to falsification of datafalsification of data

Should include outliers and give Should include outliers and give probable reasons or find out probable reasons or find out statistically acceptable ways of statistically acceptable ways of trimming outlierstrimming outliers

Group 2Group 2

A group of medical students conducted a A group of medical students conducted a research on the awareness of diabetic diet research on the awareness of diabetic diet in medical clinic participants. Their in medical clinic participants. Their research was recognized as the best research was recognized as the best undergraduate research and later they undergraduate research and later they submitted the same research paper to two submitted the same research paper to two different journals to see which journal different journals to see which journal publishes it first. publishes it first.

Unethical as it would result in "inadvertent Unethical as it would result in "inadvertent double-counting or double-counting or inappropriate weightinginappropriate weighting of the results of a single study, which of the results of a single study, which distorts distorts the available evidencethe available evidence

-it would give a false idea of the number -it would give a false idea of the number of publications in a given areaof publications in a given area

-wasting of resources on the review and -wasting of resources on the review and publication processpublication process

Should submit to one journal and wait for Should submit to one journal and wait for response prior to submitting to anotherresponse prior to submitting to another

Group 3Group 3

Students are required to prepare a Students are required to prepare a research proposal during their research proposal during their undergraduate program. Nimal undergraduate program. Nimal developed the idea for his project and developed the idea for his project and discussed with a friend. Several months discussed with a friend. Several months later, he found that his idea had been later, he found that his idea had been submitted as a research proposal by his submitted as a research proposal by his friend without his knowledge.friend without his knowledge.

Unethical as failure to give credit to the Unethical as failure to give credit to the person whose idea it is (intellectual person whose idea it is (intellectual property) amounts to plagiarismproperty) amounts to plagiarism

Should discuss and include as co-Should discuss and include as co-authorauthor

Group 4Group 4

Four friends decide to work together on a Four friends decide to work together on a research project during the vacation. One research project during the vacation. One of them went abroad during the vacation of them went abroad during the vacation and did not contribute to the research. and did not contribute to the research. The friends include all 4 names in a The friends include all 4 names in a presentation made at a scientific presentation made at a scientific congress. congress.

Unethical as only those who Unethical as only those who contributed intellectually should be contributed intellectually should be cited as authorscited as authors

Those who contribute in other ways Those who contribute in other ways may be acknowledgedmay be acknowledged

Group 5Group 5

A group of undergraduate students A group of undergraduate students planned a research project on the planned a research project on the detection of fetal abnormalities in the detection of fetal abnormalities in the second trimester, by ultrasound second trimester, by ultrasound scanning. They collected data from the scanning. They collected data from the scan room without informing the mothersscan room without informing the mothers

Unethical as informed consent was not Unethical as informed consent was not takentaken

Should have informed mothers of their Should have informed mothers of their intent even though there is no intent even though there is no particular advantage/disadvantage to particular advantage/disadvantage to the mother in doing sothe mother in doing so

Group 6Group 6

A group of undergraduate students A group of undergraduate students collected data from a group of bank collected data from a group of bank officers, with their consent, regarding their officers, with their consent, regarding their working hours and salary with regards to working hours and salary with regards to the prevalence of high blood pressure. the prevalence of high blood pressure. Subsequently the researchers gave the Subsequently the researchers gave the same data to another group who were in same data to another group who were in need of same data variables.need of same data variables.

Unethical as Unethical as violating violating principles of principles of consent and confidentialityconsent and confidentiality

Data can be used for a secondary Data can be used for a secondary purpose which was not first considered purpose which was not first considered as long asas long as

-- informed consent for sharing has been informed consent for sharing has been givengiven

-- identities anonymisedidentities anonymised

-- due consideration to access restrictionsdue consideration to access restrictions

Develop ethical guidelines for data Develop ethical guidelines for data sharing?sharing?

Why should there be research ethics?Why should there be research ethics?

To protect participants /patients To protect participants /patients /society /resources //society /resources /researcher?researcher?

To ensure accuracy of scientific To ensure accuracy of scientific knowledgeknowledge

To protect intellectual and property rightsTo protect intellectual and property rights

To protect To protect participants/patients/society/resourcesparticipants/patients/society/resources

Protect from harmProtect from harm Show respect Show respect -privacy /confidentiality -privacy /confidentiality -Informed consent -Informed consent Refrain from Coercion and undue Refrain from Coercion and undue

inducement inducement When do incentives amount When do incentives amount to coersion/undue inducement?to coersion/undue inducement?

http://www.ncbi.nlm.nih.gov/pmc/articles/http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2600442PMC2600442

Refrain from exploitation of vulnerable Refrain from exploitation of vulnerable participants participants Who are the vulnerable Who are the vulnerable groups?groups?

Refrain from indiscriminate use of Refrain from indiscriminate use of resourcesresources

Ensure Favorable Risk-Benefit Ratio: risk Ensure Favorable Risk-Benefit Ratio: risk should be minimized & potential benefit to should be minimized & potential benefit to society must outweigh riskssociety must outweigh risks

Must be of social value: improvement of Must be of social value: improvement of health/knowledge for the benefit of health/knowledge for the benefit of society/sciencesociety/science

high social value: use of stem cells to improve quality of life for Huntington's disease patients

less social value: drug studies conducted to obtain data that allows a new drug to compete in the healthcare marketplace even though existing effective and often cheaper therapeutics are already available

To ensure accuracy of scientific knowledgeTo ensure accuracy of scientific knowledge Should be methodically rigorous - Should be methodically rigorous -

Scientific validity Scientific validity Fair subject selection: with inclusion / Fair subject selection: with inclusion /

exclusion criteria & a valid number of exclusion criteria & a valid number of subjects in order to project results to the subjects in order to project results to the population population

State research method State research method clearly so that clearly so that another person can conduct advanced another person can conduct advanced study in future by using publicationstudy in future by using publication

Is it ethical to copy the methodology from a Is it ethical to copy the methodology from a published paper?published paper?

Do not gDo not gloss research methodloss research method Should not falsify/modify/omit dataShould not falsify/modify/omit data Use actual data for analysis/cannot include Use actual data for analysis/cannot include

someone else's datasomeone else's data Report errorsReport errors Be aware of conflict of interestBe aware of conflict of interest Should not withhold and/or ‘vaguing up’ Should not withhold and/or ‘vaguing up’

informationinformation Keep data and material for 5 yearsKeep data and material for 5 years Data and material should be available to Data and material should be available to

othersothers

Do not present/publish paper from Do not present/publish paper from incomplete research or from anticipated incomplete research or from anticipated outcomesoutcomes

Should not duplicate publications and Should not duplicate publications and submissions submissions

Avoid piecemeal publicationAvoid piecemeal publication Should be reviewed Independently by Should be reviewed Independently by

unaffiliated individualsunaffiliated individuals

To protect intellectual and property To protect intellectual and property rightsrights

Citation and authorshipCitation and authorship

inclusion-Writing and significant inclusion-Writing and significant scientific contributionscientific contribution

order- order of contributionorder- order of contribution -actual researchers -actual researchers -approval must be sought -approval must be sought

to to include a nameinclude a name

Whenever somebody else’s work is Whenever somebody else’s work is quoted reference should be made to quoted reference should be made to the original author the original author (Piracy vs plagiarism)(Piracy vs plagiarism)

Acknowledgement should include the Acknowledgement should include the names of person who helpednames of person who helped

Breach of ethics in research Breach of ethics in research would amount to scientific would amount to scientific

misconductmisconduct

Scientific misconductScientific misconduct

Fraud : invention/fabrication of dataFraud : invention/fabrication of data

Plagiarism : copying data, ideas, text Plagiarism : copying data, ideas, text without acknowledgement of sourcewithout acknowledgement of source

Piracy : infringement of a copyrightPiracy : infringement of a copyright

Submitting/Publishing the same paper to Submitting/Publishing the same paper to different journalsdifferent journals

Scientific misconduct …Scientific misconduct …

Not informing a collaborator of your Not informing a collaborator of your intent to file a patent in order to make intent to file a patent in order to make sure that you are the sole inventor sure that you are the sole inventor

Including a colleague as an author on a Including a colleague as an author on a paper in return for a favor even though paper in return for a favor even though the colleague did not make a serious the colleague did not make a serious contribution to the paper contribution to the paper

Trimming outliers from a data set without Trimming outliers from a data set without discussing your reasons in paper discussing your reasons in paper

Using an inappropriate statistical Using an inappropriate statistical technique in order to enhance the technique in order to enhance the significance of your research significance of your research

Bypassing the peer review process and Bypassing the peer review process and announcing your results through a press announcing your results through a press conference without giving peers conference without giving peers adequate information to review your work adequate information to review your work

Conducting a review of the literature that Conducting a review of the literature that fails to acknowledge contributions of fails to acknowledge contributions of others others

Stretching the truth on a grant application Stretching the truth on a grant application in order to convince reviewers that your in order to convince reviewers that your project will make a significant project will make a significant contribution to the field contribution to the field

Giving the same research project to two Giving the same research project to two graduate students in order to see who can graduate students in order to see who can do it the fastest do it the fastest

Overworking, neglecting, or exploiting Overworking, neglecting, or exploiting research students research students

Making derogatory comments and Making derogatory comments and personal attacks in your review of personal attacks in your review of author's submission author's submission

Making significant deviations from the Making significant deviations from the research protocol approved by the research protocol approved by the Review Board without informing the Review Board without informing the committeecommittee

Not reporting an adverse event in a Not reporting an adverse event in a human research experiment human research experiment

Wasting animals in research Wasting animals in research

Exposing students and staff to Exposing students and staff to biological risks biological risks

Rejecting a manuscript for publication Rejecting a manuscript for publication without even reading it without even reading it

Sabotaging someone's workSabotaging someone's work

Rigging an experiment so you know how Rigging an experiment so you know how it will turn out it will turn out

Deliberately overestimating the clinical Deliberately overestimating the clinical significance of a new drug in order to significance of a new drug in order to obtain economic benefits obtain economic benefits

Ethical review committee Ethical review committee (Institutional Review Boards)(Institutional Review Boards)

Convened to Convened to maintain maintain ethical standards ethical standards of practice of practice

in researchin research ensure ensure protection of subjects/research protection of subjects/research

workers workers from harm or exploitationfrom harm or exploitation to provide to provide reassurance to the public reassurance to the public protect researchers protect researchers from unjustified from unjustified

criticismcriticism

Procedure for ethical clearanceProcedure for ethical clearance

Fill ethical clearance form and attach Fill ethical clearance form and attach proposal, questionnaires, informed proposal, questionnaires, informed consent forms, information leaflets etc., consent forms, information leaflets etc., and submitand submit

When ethical clearance is granted, When ethical clearance is granted, ddata ata collection can commence according to collection can commence according to the approved methodologythe approved methodology

A group of undergraduate students A group of undergraduate students planned a research on family planning planned a research on family planning practices of Sri Lankan females. As they practices of Sri Lankan females. As they were close to the deadline for presenting were close to the deadline for presenting their results, they started collecting their results, they started collecting information form participants before information form participants before formal approval by the ethics review formal approval by the ethics review committeecommittee

What should members of ethics What should members of ethics review committees consider in review committees consider in evaluating a proposal for ethical evaluating a proposal for ethical clearance?clearance?

Elements of a reviewElements of a review

Send to: Send to: deepthiforensic2000@gmail.comdeepthiforensic2000@gmail.com

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