Protection of patient rights and welfare in the VA cooperative studies program.

Four VA Cooperative Studies Program Coordinating Centers have been established by the Cooperative Studies Program of the Medical Research Service of the Veterans Administration. Affiliated with each Coordinating Center is a Human Rights Committee (HRC). These HRCs function similarly to the Institutional Review Board but differ from it in many significant ways. This paper presents the organizational structures, the responsibilities, and the inherent dynamics of the HRCs. With clear and defined objectives and guidelines, the HRCs monitor the multicenter cooperative studies conducted within the VA health care system. The HRCs strive to balance the need for protecting patients' rights and welfare with the need for research. Its specific role is to ensure that multicenter trials are planned, implemented, and evaluated such that the rights and welfare of study subjects are protected. This is accomplished by reviewing the content and the procedures of the informed consent during the planning stage as well as by the site visits and continuing reviews during the ongoing phase of each cooperative study.