University of Alabama at Birmingham (UAB), Alabama A & M University (AAMU), the University of South Alabama (USA), and Auburn University (AU) have entered into a partnership to enhance their human subjects protection programs. The premise on which the improvements are based is that an effective program requires standards of performance, data for judging performance, and education about the standards and their application. A second key principle is that an effective program must educate all the key constituencies that make up the program: the Institutional Review Board for Human Use (IRB), the IRB staff, investigators and their staff, and the participants themselves. Discussions with clinical investigators, support staff, IRB members and others confirmed the need for improved data collection and management and new educational initiatives. The proposal addresses four specific aims. These are: to build a partnership of core institutions to collaborate on the development and dissemination of improved tools for the protection of human subjects; to develop systems to manage information so that IRBs, staff, and investigators have ready access to accurate, timely, and informative data to augment the protection of human subjects, assess the performance of the program, and link with other compliance systems; to develop a library of materials for ongoing training of investigators, study staff, IRB members, and IRB staff; and to develop informational material for prospective study participants explaining the protections afforded them. Improvement in information management will be achieved by building on the existing UAB IRB database to increase its versatility and reporting features. To address the need for ongoing training, new materials will be developed for research staff training and advanced training for investigators and IRB members using primarily a web-based format. Participant brochures will also be developed for prospective research subjects. By sharing information and tools through the partnership, we will strengthen the protections for human research subjects throughout the state and set the stage for future progress in this area.
