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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
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Context
International IRB/Ethic Committees Capacity
Clinical trials and NIH/USG funding
PEPFAR and public health evaluations (PHEs)
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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)
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Issues:
Concept of RiskInformed consent standardsStandard care for control groupRecruitment selectionConfidentiality standards
Regulatory barriersFinancial barriers
Capacity building challengesStudent involvement
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Issues:
•Concept of RiskInformed consent standards•Standard care for control groupRecruitment selectionConfidentiality standards
•Regulatory barriersFinancial barriers
•Capacity building challengesStudent involvement
![Page 6: Context International IRB/Ethic Committees Capacity Clinical trials and NIH/USG funding](https://reader036.vdocuments.net/reader036/viewer/2022062304/56814609550346895db3185a/html5/thumbnails/6.jpg)