The Role and Importance of Institutional Review Boards in a University Setting
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Transcript of The Role and Importance of Institutional Review Boards in a University Setting
Frederick G More, DDS, MSProfessor
New York UniversityNew York, NY, USA
July 2009 University of Haiti
Definition:External ethics review:
This is a general term that describes a review of a proposed research project by a group that does not include anyone from the project.
Institutional Review Board: This is a specific term that relates to external
ethics review in the U.S.
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What is “research ethics”?1. Compliance with regulations?2. Review by Institutional Review Boards?3. Design of research?4. Use of data, publication, fabricating data?5. Process of gaining consent?6. Competence of researcher?7. Fairness of equity to access?8. Respect for subjects who volunteer?9. Sensitivity to vulnerable groups?10. Plagiarism, data integrity
July 2009 University of Haiti
July 2009 University of Haiti
History of efforts to protect subjectsExploitation of subjects
Patients on charity wards in hospitals
July 2009 University of Haiti
History of efforts to protect subjectsExploitation of subjects
Classic experiments by William Beaumont on digestion
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History of efforts to protect subjectsExploitation of subjects
Nazi medical researchers Japanese experiments with POWs and
bioweaponsU.S. research with radioactive elements
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History of efforts to protect subjectsExploitation of subjects
Tuskegee Syphilis Study – landmark for changes
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Belmont ReportProduct of the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research
Emphasized three basic ethical principlesRespect for persons
Individual autonomy Individual with reduced autonomy
BeneficenceJustice
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Research in U.S. TodayFounded on the National Research Act
Regulations by the National Institutes of Health
Assurance given by institutions that they comply with guidelines
A system of Institutional Review Boards for external review of all proposed research that uses humans
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Important MilestonesNuremberg Code (1947)
Voluntary consentBenefits outweigh the risksAbility of the subject to terminate participation
Declaration of Helsinki (1964 updated)World Medical Association (2008 is the most
recent)National Research Act (1974)*
National Commission for the Protection of Human Subjects
Belmont Report (1979)July 2009 University of Haiti
Moral Principles
Guidelines on Research Ethics
Regulations and Oversight Agencies
Ethical Review Committees
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Moral Principles
Guidelines on Research Ethics
Regulations and Oversight Agencies
Ethical Review Committees
Goal-basedDuty-basedRights based
Nuremberg CodeDeclaration of HelsinkiBelmont Report**
Common Rule (45 CFR 46)Non-discrimination policiesDHHS-OHSP
IRBs
July 2009 University of Haiti
July 2009 University of Haiti
Purpose of research?Provide new knowledge, propose new
therapies, validate present therapies, determine effectiveness, promote human welfare and well-being.
A systemic investigation, included research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
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Research versus TherapyPractice or therapy refers to interventions
that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.
Research designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.
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Institutional Review BoardsExist to protect human subjects used in
researchMulti-center clinical trialsDocuments that govern the IRB:
Belmont Report (U.S.)Declaration of Helsinki (world-wide)Guideline for Good Clinical Practice
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Reviewing researchProtection of human subjects – primary goal
Design of the researchGoals and AimsConsent/AssentVoluntarinessRight to withdrawInjury
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Example of a projectA U.S. researcher comes to Haiti, works with
faculty members at the University of HaitiGoal: to discover how Haitians use tobacco,
alcohol, and other substancesDescription: Haitian interviewers will be
recruited and trained in how to interviewInterviewers will go to Haitian villages and
conduct interviews with persons who are locals in the villages
Data will be analyzed to define which substances are used, how often, and so on
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The Review ProcessThe researcher wants to use human subjects
to find out something he does not knowA survey is developedInterviewers are trained in HaitiInterviewers will conduct and oral surveyParticipation is completely voluntaryConfidential and anonymous
The benefit will be the discovery of information about alcohol and tobacco use in Haiti
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Anatomy of a project: IRBExternal review body – researchers, members who
know the guidelines but are not scientists; and, a public member. An administrator should be appointed to keep records, minutes, and monitor studies.
Review: Design of the project Study activities Equity and access (selection of subjects) Consent (informed, voluntary, competent) Assessment of risks and benefits Use of data
Yearly continuation reportsMonitor the research until it is finished
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The review processA primary and secondary reviewer are selectedReview the application and the proposed research
The study designHow subjects are recruited and selectedWhat are the risks to the subjectsAre there benefits to the subjects or the communityHow is privacy maintainedHow will the data be analyzed and by whomWhat is the mechanism for review adverse events
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Board actionsApproval – the study meets all criteria and is
okay to commenceConditional approval – the study meets the
criteria but need a few minor changes. Once the changes are made, the study may commence
Deferral – the study needs major changes and will be reviewed after the changes are made
Disapproval – the study is not acceptable and may not commence in its present form
July 2009 University of Haiti
July 2009 University of Haiti
Researcher’s responsibilityConsider the design of the studyAre human subjects necessary to the
outcome?What measures
Protect subjects from risksInform subjects of potential risksProvide privacyPermit subjects to withdraw w/o penalty
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External Ethics Review ExperiencesAn external ethics review board should be
considered to review all research that uses human subjectsChairman – scientific member who conducts
meetings and helps group to arrive at a consensusScientific members – members with specific
expertise who will review applicationsNon-scientific members – university faculty
members who look at other aspects of the application
Community member – a respected person from the community who represents a community focus
A staff person who maintains recordsJuly 2009 University of Haiti
After the study commencesAnnual review (or sooner if the board
chooses): the board reviews the progress of the study to see if it is meeting its goals
Amendments: the investigator requests changes in the protocol
Adverse events: required reporting of adverse events that are expected or unexpected
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Next steps?1. Make a decision to review all research using
human subjects a) Locally (research conducted by University of
Haiti faculty alone or in collaboration with others
b) Regionally (universities doing research collaborating as a single committee)
2. Get an expert consult to help with applications and processes
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Next steps3. Review the standards that exist (Declaration
of Helsinki)4. Develop an application process and appoint
a committee 5. Research should be reviewed in a timely
manner6. Develop a process to keep track of all the
research that has been reviewed
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Final Thoughts:No research should ever be conducted using
human subjects without a review by an external board
The University should be a model for responsible action and oversee all research done by the faculty
The main benefit is to increase the safety for subjects and to avoid abuse
July 2009 University of Haiti
July 2009 University of Haiti