A fundamental challenge facing research institutions is how best to address an increasingly complex human subjects research environment. The proper conduct of research involving human subjects requires that institutional officials, research investigators and their staff, as well as human subjects review board members be properly trained and educated in the ethical and scientific aspects of such research. However, the addition of procedures, safeguards, and regulations to the conduct of scientific research and the review of such protocols, produces significant burdens on all parties involved. Further, the dramatically increased amount of research activity in many biomedical research centers, increasing calls for additional training and education of researchers in the ethics of research, and increases in reporting and monitoring activities, poses serious challenges to Institutional Review Boards (IRBs) and researchers. In an effort to address these concerns, this proposal seeks support for developing electronic educational programs that will (a) assist in the training of investigators, administrators, and IRB members in the safe and ethical conduct of research, and (b) track, monitor, and coordinate human subjects protocols, with an emphasis on adverse event reporting. This enhanced IRB infrastructure, employing electronic internet centered education, and information technology resources and capabilities, will facilitate the operations of our existing training and monitoring programs and provide flexibility to meet expected expanded human subjects research activities.
