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

Context

International IRB/Ethic Committees Capacity

Clinical trials and NIH/USG funding

PEPFAR and public health evaluations (PHEs)

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)

Issues:

Concept of RiskInformed consent standardsStandard care for control groupRecruitment selectionConfidentiality standards

Regulatory barriersFinancial barriers

Capacity building challengesStudent involvement

Issues:

•Concept of RiskInformed consent standards•Standard care for control groupRecruitment selectionConfidentiality standards

•Regulatory barriersFinancial barriers

•Capacity building challengesStudent involvement