This proposal seeks support to expand activities initiated by Family Health International (FHI) under the Human Subjects Enhancement Program (RFA OD-02-003). Through this grant, FHI's Office of International Research Ethics would implement a Collaborative IRB Mentoring Program (CIMP) providing consultation and mentoring to the institutional review boards of two institutions in the NIH-funded HIV Prevention Trials Network. In recent years there has been an increased awareness of the need for strengthening of human subjects protections programs (HSPP). There is evidence that these needs are greatest in the developing world, where the scarcity of financial support limits the amount of resources available for HSPPs. In addition, many of these institutional programs were created solely to review U.S. research without guidance on best or recommended practices. Much of the research ethics training currently available is targeted at research staff, and not IRBs. In the execution of the first NIH grant (RFA OD-02-003) we identified a pressing need to provide both training and basic administrative support to local HSPP or IRBs. To address the Specific Aims, FHI will: . Initiate a program of technical support and cooperation for the development of two African IRBs. . Establish a collaborative and mutually strengthening program between the African IRBs and FHI's IRB. . Create a program of IRB development that can be replicated.
