Human Subjects Research Enhancement

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The specific aims of this project are 1) to develop two educational programs on protection of human subjects at Meharry Medical College, one for investigators and one for IRB members; 2) to deepen investigators' understanding of human protections by conducting quarterly seminars on salient issues in this area; and 3) to enable the Meharry IRB to examine the local research context of organizations participating in Meharry research projects by acquiring equipment for teleconferences. The first objective will be accomplished in five steps: 1) Revise existing IRB forms and documents and improve aids for writing consent forms; 2) revise and update existing IRB manual; 3) survey existing web-based materials on human protections, both at agency regulatory sites and at other universities; 4) having examined both written and electronic materials, decide which information to put in each program; 5) assemble written, web-based, and live versions of each educatonal program. The second and third objectives are straightforward. This project will help Meharry's human protections program meet three specific challenges. First, the number of new investigators involved in human subjects research is rising rapidly because of Meharry's formal affiliation with Vanderbilt University known as the Meharry-Vanderbilt Alliance. Meharry needs a robust human protections program to ensure that these faculty members understand fully their responsibilities toward human subjects. Second, as an historically black university, Meharry has become an attractive collaborator for investigators at other institutions who study health disparities. The outcome is that still more new Meharry investigators will become involved in disparities research; again, the college needs a vigorous human protections program to train new investigators properly. Third, in the current regulatory' environment the IRB's responsibilities and procedures have changed rapidly; our human protections program needs to consolidate these changes into convenient, thorough compendia for faculty investigators and IRB members.