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Research EthicsأخلاقياتالبحثSohailBajammal, MBChB, MSc, FRCS(C), PhD(c)Assistant Professor, Faculty of MedicineVice Dean, Academic Development, Faculty of DentistryUmm Al-QuraUniversityssbajammal@uqu.edu.sa
Tuskegee Syphilis Study
Learning OutcomesBy the end of the lecture, you will be able to:Identify the importance of research ethicsAnticipate ethical issues in researchIdentify the components of informed consentKnow where to ask for help
Dark HistoryTuskegee Syphilis Experiment1932-1972; Tuskegee, AlabamaNatural history of “untreated” syphilisSubsequent Nuremberg Trials:1946-1949; Nuremberg, Germany12 trials, criminals of World War IIThe Doctors’ Trial: 23 involved in unethical experimentation on POW
Code of EthicsNuremberg Code (1947)Declaration of Helsinki (1964)
Declaration of HelsinkiWMA.net
Good Clinical PracticeICH.org
Tri-Council Policy Statementethics.gc.ca
bioethics.kacst.edu.sa
Ethical Issues in Research
Research ProblemResearch QuestionResearch DesignData CollectionData AnalysisResearch Dissemination
Ethical Principles of ResearchJusticeالإنصافCompetenceالكفاءةNon-maleficenceعدمالإيذاءIntegrityالاستقامةParticipantsResearchersDignityالكرامةBeneficenceالإحسانAutonomyالاستقلاليةResponsibilityالمسؤوليةConfidentialityالسريةHonestyالنزاهةPrivacyالخصوصية
Research ProblemResponsibilityالمسؤوليةIs it a significant problem that will benefit others? Does it worth the public money?Have you done a thorough literature review to see if other studies exist?Is it ethical to repeat the study if it has been done before?ConfirmingExtendingRefutingCompetenceالكفاءةNon-maleficenceعدمالإيذاءBeneficenceالإحسان
Research QuestionNon-maleficenceعدمالإيذاءDoes it expose the participants to unacceptable risks or invasion of privacy?Clearly identify the purpose of the study to participantsBeneficenceالإحسان
Research ProblemResearch Question
What study needs ethics approval?www.pre.ethics.gc.ca
If in doubt…..Check it outCheck with your institutional ethics review board (IRB)
Research DesignResearch DesignNon-maleficenceعدمالإيذاءIs your choice of the study design an ethical choice?Observational versus InterventionalBenefits/Risks ratioIs it methodologically sound?Do you have the expertise to do it?? PilotBeneficenceالإحسانCompetenceالكفاءةHonestyالنزاهة
Types of Possible HarmPhysicalPsychologicalSocialEconomicLegalNon-maleficenceعدمالإيذاءBeneficenceالإحسان
Vulnerable PopulationsJusticeالإنصافMinorsMinority groupsMentally incompetentPrisonersIndividuals with AIDSDignityالكرامةAutonomyالاستقلالية
Informed ConsentAbout you & the research:Who are the researchers & their contact information?Who is sponsoring?What is the purpose of the research? CompetenceالكفاءةIntegrityالاستقامةResponsibilityالمسؤوليةHonestyالنزاهة
Informed ConsentJusticeالإنصافAbout the participants:How were they selected?Assurance that: Their participation is voluntaryThey can withdraw at any timeWhat are the benefits & risks for them?What is the level and type of their involvement?How will you ensure their confidentiality?AutonomyالاستقلاليةNon-maleficenceعدمالإيذاءConfidentialityالسرية
Data CollectionRespect participants & research sitesRespect privacy & confidentialityMONITOR
Data AnalysisHow will you protect the anonymity of participants?How will you analyze the data? Do you have the experience?How long will you keep the data once analyzed? Where & how will you keep it?
Research DisseminationAuthorship:Who will do what & when?Authorship orderConflicts of interests: financialIntegrityالاستقامةHonestyالنزاهة
Research DisseminationReporting:FabricationFalsificationPlagiarism: Copying without citingParaphrasing without citingUsing other’s ideas without citingIntegrityالاستقامةHonestyالنزاهة
RetractionsWager:1988 and 2008: 529 retractionsWoolley:1978 to 2008: 463 retractions in English-language literature40% due to misconduct in the 80s60% due to misconduct in the 2000sNicola Jones. Nature Medicine. 2009
Resources
If in doubt…..Check it outCheck with your institutional ethics review board (IRB)
bioethics.kacst.edu.sa
King Saud University
kaimrc.med.sa
Summary
SummaryEthical principles of researchAnticipate ethical issues during: Research problem, question & designData collection, analysis, and disseminationComponents of informed consentConsult IRB: “If in doubt, check it out”ssbajammal@uqu.edu.sa