1. IRB ETHICAL APPROVAL CHALLENGES WITH SOLUTIONS IN RESOURCE LIMITED SETTINGS Institutionalizing Research Administration in Africa PAUL KUTYABAMI BPHARM M.A.

2. Introduction History of research is replete with unethical research and systematic atrocities committed in the name of medical research. While some may have been deliberate, many of the atrocities were unintended consequence of research activities Public concern about the safety of individuals and communities involved in research

3. Introduction Nuremberg code; the first legal attempt to deal with human participant protection Ethical review is one of the attempts to ensure protection of research participants enshrined in several international guidelines Ethical review has been largely reactive response to abuses and scandals that have marred the history of research An effective system for ethical review is a crucial safeguard for participants

4. Some of the international guidelines provide for ethical review process World Medical Association ‘Declaration of Helsinki’ …...protocol should be submitted for consideration, comment, guidance, and where appropriate, approval, to a specially appointed ethical review committee…’ Council for International Organizations of Medical Sciences (CIOMS) 1991 principle 33; ……... Sponsors and investigators are expected to submit their proposals to ethical review…… World Health Organization (WHO) ‘Guidelines for Good Clinical Practice (GCP) for trials on pharmaceutical products’ (1995) The protocol, appendices and other relevant documentation should be reviewed from a scientific and ethical standpoint by one or more review bodies…constituted appropriately for this purpose and independent of the investigator(s) and spo nsor ’. International Conference on Harmonization (ICH) ‘Harmonized Tripartite Guideline. Guideline for Good Clinical Practice’ (1996) A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion

5. Requirements for effective ethical review of research Stake holders’ support; government officials, senior members of universities and research institutions, or local researchers  Supportive policies to ensure autonomy and smooth operation of the committees  Supportive infrastructure; office space and equipment, secretarial services  Financial resources Availability of competent and committed staff to man and sit on Ethical review committees  Trained staff in research ethics  Motivated staff

6. Characteristic of an ineffective ethical review system Process failure Long turn around time Committee decisions may ignored or overridden Ethical review may be seen just as a formality

7. Ethical review process in action

8. Challenges Few training program in ethics and most of them emphasize the western style of ethics  Small pool of trained people to take up roles in IRBs  Members may not appreciate their roles or may misunderstand the roles of an IRB  The few people who volunteer to take up roles may become fatigues when they overstay on the IRB Limited training in ethics

9. Ethical review Vs Scientific review Scientifically unsound research is unethical and it is not permissible to undertake unethical research for the purpose of yielding good scientific knowledge Ethics committees tend to concentrate more on science than on the ethics

10. Independence of IRBs It improves the likelihood that decisions made free are from inappropriate influences that could distort their task of evaluating risks and potential benefits  Sometime members may be subjected to indirect institutional “pressure” to facilitate the acceptance of internationally sponsored research projects that bring with them substantial resources for the institution Members may feel constrained because they are examining the work of their colleagues or their supervisors  It is advisable that in such situation, such members should not participate in protocol review unless they are able to separate these concerns from their task

11. Resource constraints Ethical review activities require resources both financial and non financial to sustain them.  Ethical review committees may not have clear cut sources of funding  Rely on the goodwill of investigators or institution  Limited funding constrains on the activities of the committee  Failure to conduct meeting  Delays in communicating to investigator  Failure to recruit secretariat staffs

12. Recruitment and retention Members of IRC are often expected to undertake ethical review activities in addition to own duties with inadequate or no compensation for time and efforts.  reduces the numbers of people willing to devote time and effort in the process  Difficulty in attracting community members

13. Limited community representation and partic ipation Guidelines require that community representatives in IRB meeting.  Members chosen  May not necessarily represent the actual research participants  Not guarantee that participants’ aspirations are considered during the review process

14. Variation in IRB decision making IRBs are required to demonstrate autonomy in the interpretation of regulations.  IRBs must apply their own discretion when deciding how research proposals will be evaluated to meet the ethical criteria  Therefore there is always a wide variation in the standard applied to the review and approval of protocols between different IRB

15. Lack of institutional guidelines and SOPs Guidelines exist at international and national level  Present broad ethical principles and may not be effectively applied directly at the local setting  Members are often left to resolve issues on the basis of personal knowledge  Looking at the ever increasing complex nature of research specific areas of science may require specific guidelines

16. Tension between IRB and investigators There is always a natural tension between IRB and other stake holder of research  IRBs tend to operate on the presumption that investigators are intent on exploiting disadvantaged and poorly educated subjects Vs  Investigators’ concerned that IRB's impose impractical demands that will impede the researcher's ability to meet standards of good scientific practice

17. IRB credibility Effectiveness of the ethical review process lies in the credibility of the IRB both within the institution and the surrounding community. Credibility depends upon the  Competence and actions of IRB members,  The degree of cooperation between the investigator and the IRB,  The importance granted the IRB by the institutional administration, and  The extent to which IRB decisions reflect sensitivity to participant and community perspectives

18. Remedies to the Challenges Establishing more training programs in ethics within countries to generate a pool of staff to take up roles on IRCs Developing appropriate IRB policies and guidelines at institutions to support the independence and integrity of ethical committees Institutional commitment to support ethical review activities in terms of both finance and infrastructure Development of SOP for IRB operation to promote consistence of operations of ethical committees

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