1. International Research: Pragmatic and Idealistic Thoughts on Capacity Building and the Protection of Human Subjects Jessica Justman, M.D. Institutional Review Board Educational Conference Current IRB Challenges and Practical Solutions April 20, 2010

2. Context International IRB/Ethic Committees Capacity Clinical trials and NIH/USG funding PEPFAR and public health evaluations (PHEs)

3. Context International IRB/Ethic Committees Capacity Clinical trials and NIH/USG funding typically interventional trials PEPFAR and public health evaluations (PHEs) CDC, USAID, DoD funding Office of Global AIDS Coordinator (OGAC) operational research (non-interventional)

4. Issues: Concept of Risk Informed consent standards Standard care for control group Recruitment selection Confidentiality standards Regulatory barriers Financial barriers Capacity building challenges Student involvement

5. Issues: Concept of Risk Informed consent standards Standard care for control group Recruitment selection Confidentiality standards Regulatory barriers Financial barriers Capacity building challenges Student involvement