1. Frederick G More, DDS, MS Professor New York University New York, NY, USA July 2009University 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. July 2009University of Haiti

3. 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 2009University of Haiti

4. Historical background July 2009University of Haiti

5. History of efforts to protect subjects Exploitation of subjects Patients on charity wards in hospitals July 2009University of Haiti

6. History of efforts to protect subjects Exploitation of subjects Classic experiments by William Beaumont on digestion July 2009University 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 July 2009University of Haiti

8. History of efforts to protect subjects Exploitation of subjects Tuskegee Syphilis Study – landmark for changes July 2009University 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 July 2009University 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 July 2009University 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) July 2009University of Haiti

12. The structure of Research Oversight – U.S. Moral Principles Guidelines on Research Ethics Regulations and Oversight Agencies Ethical Review Committees July 2009University of Haiti

13. The structure of Research Oversight – U.S. Moral Principles Guidelines on Research Ethics Regulations and Oversight Agencies Ethical Review Committees Goal-based Duty-based Rights based Nuremberg Code Declaration of Helsinki Belmont Report** Common Rule (45 CFR 46) Non-discrimination policies DHHS-OHSP IRBs July 2009University of Haiti

14. World Medical Association Association Médicale Haitienne 1ère Av. du Travail #33 – Bois Verna Port-au-Prince Haiti, W.I. Tel: (509) 245-2060 / 245-6323 Fax: (509) 245-6323 e-mail: amh@amhhaiti.net Dr Claude Surena, Président Dr. Dernst Eddy Jean-Baptiste, Secrétaire Général July 2009University of Haiti

15. A structure for reviewing research July 2009University of Haiti

16. 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. July 2009University of Haiti

17. 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. July 2009University of Haiti

18. What are the considerations? What is the difference between research and treatment? What is our duty to subjects in studies? Do research ethics compare with therapy? How does the public regard biomedical research? What about qualitative research? Responsibility for translational research? July 2009University of Haiti

19. 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 July 2009 University of Haiti

20. Reviewing research Protection of human subjects – primary goal Design of the research Goals and Aims Consent/Assent Voluntariness Right to withdraw Injury July 2009 University of Haiti

21. 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 July 2009University of Haiti

22. 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 July 2009University of Haiti

23. Types of review Exempt from review “Expedited” review Full review July 2009 University of Haiti

24. 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 July 2009University of Haiti

25. 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 July 2009University of Haiti

26. Anatomy of a project: Researcher’s responsibility Consider the design of the study Who is supporting the research? 1. Researcher’s funds to discover opportunity for health promotion 2. A U.S. Tobacco Co who may use the data to develop a new market 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 July 2009University of Haiti

27. Respect of Persons: Autonomy Informed consent Surrogate consent Assent Privacy and confidentiality Protection of subjects July 2009University of Haiti

28. 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 July 2009University of Haiti

29. Personal experiences July 2009University of Haiti

30. 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 July 2009University of Haiti

31. 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 July 2009University of Haiti

32. 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 July 2009University of Haiti

33. 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 July 2009University of Haiti

34. Next steps 3. 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 manner 6. Develop a process to keep track of all the research that has been reviewed July 2009University of Haiti

35. 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 2009University of Haiti

36. Questions? July 2009University of Haiti