Ensuring that scientific research can flourish under conditions in which the best interests of research participants are protected remains the primary goal of the Emory Institutional Review Board (IRB). The purpose of the proposed project is to implement strategies to strengthen our IRB activities that can be maintained to ensure optimal protection of human subjects engaged in research. Specifically, the proposed methods will incorporate both educational initiatives and technology development to facilitate the research initiatives of Emory University and several collaborating institutions: Morehouse School of Medicine; Georgia Tech Research Institute; Children's Healthcare of Atlanta; and Grady Health System.
The specific aims of the proposed project are: 1) To facilitate IRB review of collaborative research between the participating institutions; 2) To share Emory University's Human Subjects Research Best Practices Manual and develop new educational initiatives with Emory affiliated and collaborating institutions; 3) To provide expanded human subject protection training to investigators, research staff, IRB committee members and IRB staff; 4) To develop a data and safety monitoring program intervention that allows ongoing monitoring of patient safety and the sharing of safety information with other collaborating institutions; 5) To enhance further infrastructure support for IRB proposal submission, renewal, and tracking; and 6) To develop a technology solution to aid the preparation of the consent form and facilitate the consent process.
These aims will be accomplished through the development of guidelines and documents for collaborative research between the participating institutions, as well as a multi-institution retreat and program training sessions and participation in national meetings on human subjects protections. The development of an Informed Consent Builder that will prompt investigators to explore study-specific aspects of the consent process is also planned. The current IRBWise system will be modified to incorporate conditional branching to aid the protocol submission process. Further, community outreach to enhance awareness of research activities, opportunities, and subjects' rights, as well as the addition of a subject advocate/ombudsman position demonstrates Emory's sustained commitment to expanding the scope of human subjects protection.
