The Role and Importance of Institutional Review Boards in a University Setting

1. The Role and Importance of Institutional Review Boards in a University Setting Frederick G More, DDS, MS Professor New York University New York, NY, USA University of Haiti

2. 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. University of Haiti

3. What is “research ethics”? • Compliance with regulations? • Review by Institutional Review Boards? • Design of research? • Use of data, publication, fabricating data? • Process of gaining consent? • Competence of researcher? • Fairness of equity to access? • Respect for subjects who volunteer? • Sensitivity to vulnerable groups? • Plagiarism, data integrity University of Haiti

4. Historical background University of Haiti

5. History of efforts to protect subjects • Exploitation of subjects • Patients on charity wards in hospitals University of Haiti

6. History of efforts to protect subjects • Exploitation of subjects • Classic experiments by William Beaumont on digestion University of Haiti

7. History of efforts to protect subjects • Exploitation of subjects • Nazi medical researchers • Japanese experiments with POWs and bioweapons • U.S. research with radioactive elements University of Haiti

8. History of efforts to protect subjects • Exploitation of subjects • Tuskegee Syphilis Study – landmark for changes University of Haiti

9. Belmont Report • Product of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • Emphasized three basic ethical principles • Respect for persons • Individual autonomy • Individual with reduced autonomy • Beneficence • Justice University of Haiti

10. Research in U.S. Today • Founded 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 University of Haiti

11. Important Milestones • Nuremberg Code (1947) • Voluntary consent • Benefits outweigh the risks • Ability 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) University of Haiti

12. The structure of Research Oversight – U.S. Ethical Review Committees Regulations and Oversight Agencies Guidelines on Research Ethics Moral Principles University of Haiti

13. The structure of Research Oversight – U.S. Ethical Review Committees IRBs Common Rule (45 CFR 46) Non-discrimination policies DHHS-OHSP Regulations and Oversight Agencies Nuremberg Code Declaration of Helsinki Belmont Report** Guidelines on Research Ethics Goal-based Duty-based Rights based Moral Principles University of Haiti

14. A structure for reviewing research University of Haiti

15. 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. University of Haiti

16. Research versus Therapy • Practice 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. University of Haiti

17. Institutional Review Boards • Exist to protect human subjects used in research • Multi-center clinical trials • Documents that govern the IRB: • Belmont Report (U.S.) • Declaration of Helsinki (world-wide) • Guideline for Good Clinical Practice University of Haiti

18. Reviewing research • Protection of human subjects – primary goal • Design of the research • Goals and Aims • Consent/Assent • Voluntariness • Right to withdraw • Injury University of Haiti

19. Example of a project • A U.S. researcher comes to Haiti, works with faculty members at the University of Haiti • Goal: to discover how Haitians use tobacco, alcohol, and other substances • Description: Haitian interviewers will be recruited and trained in how to interview • Interviewers 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 University of Haiti

20. The Review Process • The researcher wants to use human subjects to find out something he does not know • A survey is developed • Interviewers are trained in Haiti • Interviewers will conduct and oral survey • Participation is completely voluntary • Confidential and anonymous • The benefit will be the discovery of information about alcohol and tobacco use in Haiti University of Haiti

21. Anatomy of a project: IRB • External 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 reports • Monitor the research until it is finished University of Haiti

22. The review process • A primary and secondary reviewer are selected • Review the application and the proposed research • The study design • How subjects are recruited and selected • What are the risks to the subjects • Are there benefits to the subjects or the community • How is privacy maintained • How will the data be analyzed and by whom • What is the mechanism for review adverse events University of Haiti

23. Board actions • Approval – the study meets all criteria and is okay to commence • Conditional 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 University of Haiti

24. Personal experiences University of Haiti

25. Researcher’s responsibility • Consider the design of the study • Are human subjects necessary to the outcome? • What measures • Protect subjects from risks • Inform subjects of potential risks • Provide privacy • Permit subjects to withdraw w/o penalty University of Haiti

26. External Ethics Review Experiences • An external ethics review board should be considered to review all research that uses human subjects • Chairman – scientific member who conducts meetings and helps group to arrive at a consensus • Scientific members – members with specific expertise who will review applications • Non-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 records University of Haiti

27. After the study commences • Annual 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 University of Haiti

28. Next steps? • Make a decision to review all research using human subjects • Locally (research conducted by University of Haiti faculty alone or in collaboration with others • Regionally (universities doing research collaborating as a single committee) • Get an expert consult to help with applications and processes University of Haiti

29. Next steps • Review the standards that exist (Declaration of Helsinki) • Develop an application process and appoint a committee • Research should be reviewed in a timely manner • Develop a process to keep track of all the research that has been reviewed University of Haiti

30. 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 University of Haiti

31. Questions? University of Haiti