context international irb/ethic committees capacity clinical trials and nih/usg funding

Download Context International IRB/Ethic Committees Capacity Clinical trials and NIH/USG funding

Post on 13-Jan-2016

40 views

Category:

Documents

0 download

Embed Size (px)

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 - PowerPoint PPT Presentation

TRANSCRIPT

  • 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 fundingPEPFAR and public health evaluations (PHEs)

  • ContextInternational IRB/Ethic Committees Capacity

    Clinical trials and NIH/USG fundingtypically interventional trials

    PEPFAR and public health evaluations (PHEs)CDC, USAID, DoD fundingOffice 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 standardsStandard care for control groupRecruitment selectionConfidentiality standards

    Regulatory barriersFinancial barriers

    Capacity building challengesStudent involvement

  • ****