A REVIEW OF THE TWO-TIERED 1RB REVIEW SYSTEM FOR DOD SPONSORED, FEDERALLY FUNDED RESEARCH: ARE TWO TIERS ONE TIER TOO MANY?

Abstract

Essential to the conduct of research is the protection of the research participant. Beginning with the Nuremberg Code, regulations have been created for just this purpose. These regulations require that federally funded research involving the use of human subjects be reviewed on a local level by an institutional review board (IRB). Some of the human subjects research that is sponsored by the Department of Defense (DoD) and funded by the U. S. Army Medical Research and Materiel Command is required to undergo a second level of review by The Surgeon General's Human Subjects Research Review Board (HSRRB). This second level review adds additional time onto the approval cycle before research can be implemented. Some researchers feel that this second level review is unnecessary as the current regulations and local Institutional Review Boards (IRB) provide adequate protection for the research subject. The objective of this project is to attempt to address this concern of the research community. To meet this objective, a subset of locally approved greater than minimal risk (GTMR) protocols submitted for second level review by the U.S. Army Surgeon General's HSRRB during 1999, 2000, and 2001 was assessed for compliance with Federal human subject protection regulations, 45 CFR 46, 32 CFR 219, 21 CFR 50 and 56. Following this compliance review, the minutes from the review conducted by the HSRRB were examined to determine the deficiencies, if any, that were identified during the second level review.