An institutional review board-based clinical research quality assurance program.

Despite the acknowledged importance of quality assurance in the clinical research process, the problem of how such a program should be implemented at the level of an academic teaching hospital or a similar institution has not been addressed in the literature. Despite the fact that quality assurance is expected in programs which certify and accredit Institutional Review Boards (IRBs), very little is known about the role of the IRB in programs of clinical research quality assurance. In this article we consider the definition of clinical research quality assurance, and describe a program designed to achieve it. The key elements of such a program are education at the site level, which has both mandatory and voluntary components, and an auditing and monitoring program, which reinforces the education on quality assurance. The role of the IRB in achieving the program goals and the organizational placement of the quality assurance program within the IRB structure and function are important items of discussion.