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Introduction
Research involving the dead has not been regulated, and little, if any, institutional oversight has been provided. As a result, the numbers and types of research projects involving the dead are at best poorly characterized and at worst, unknown. The University of Pittsburgh instituted a mechanism for oversight of such research in June 2002. In this article, we report the experience of that oversight body, the Committee for Oversight of Research Involving the Dead (CORID), during its first 18 months.
Background
CORID provides oversight of research involving the dead in three categories: (1) "brain dead" cadavers in a clinical setting (i.e., those with functioning cardiovascular systems); (2) nonheartbeating cadavers in a clinical setting; and (3) cadavers, body parts, and/or tissues obtained outside a clinical setting. The committee was formed after an investigator wanted to test a new device in humans and determined that the best subjects would be those who were brain dead. The institutional review board (IRB) concluded that this study was not in their jurisdiction because their review, as mandated by federal policy (i.e., Department of Health and Human Services regulations), is limited to living human subjects. The investigator then contacted the hospital ethics committee, which considered the case, reviewed the literature and current regulations, and explored how such research is conducted at other institutions. It approved the study on the basis of criteria that they had drafted. Based in part on the ethics committee's analysis and its recommendation for an oversight body distinct from the IRB, the Senior Vice Chancellor for the Health Sciences called for the establishment of CORID. Both the university and the hospital approved a policy that mandates CORID review of research involving the dead and establishes relevant procedures and guidelines.
CORID Process
The committee is chaired by the Associate Vice Chancellor for Clinical Research, and the membership is composed of physicians (Transplantation Surgery, Critical Care Medicine, and Anatomic Pathology), nurses, ethics committee members, clergy, and community representatives. There is also representation from the Research Conduct and Compliance Office, which has jurisdiction over the IRB.
The full committee reviews all studies submitted and votes for approval, approval with modification, or disapproval. Depending on the nature of the proposed research and the complexity of the review required, the committee...