The role of institutional support in protecting human research subjects.

Institutional review boards (IRBs) and the federal "assurance" procedures play critical roles in the current research and regulatory environments for clinical research in academic medical centers and other institutions. The author focuses on what institutions can and ought to do to create an infrastructure that assures the protection of human subjects. Specifically, an institution should (1) create an ethics infrastructure in which both IRBs and the function of protecting human subjects are respected; (2) assure that adequate resources (space, staff, equipment) are available; (3) support IRB members with appropriate recognition and time, since their IRB workloads can be heavy; and (4) provide adequate and appropriate education for IRB administrators, members, and staff, and for investigators and research staff. Academic medical centers should also use their expertise in analyzing the current system and developing means of improving it. Nevertheless, providing adequate resources for proper research conduct will be challenging, given the current financial limitations within academic medical centers.