Post on 08-Jan-2018
description
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