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Institutional Review Boards under stress: will they explode or change?

INSTITUTIONAL REVIEW boards (IRBs), created some 20 years ago by the US government as a mechanism for the protection of human research subjects, now find themselves under pressure from mounds of paperwork, regulatory fire from the federal bureaucracy, and economic constraints from the institutions they serve. Never before has such a pressure-cooker atmosphere prevailed within the IRB system, leading government officials, university administrators, research sponsors, and IRB members to wonder whether the IRB system will crack or reform. Background of the Problem The National Research Act of 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, also mandated the establishment of IRBs in all research organizations receiving funds to support research using human subjects. The legislation also directed the national commission to identify ethical principles relevant to human subjects research, develop guidelines for the conduct of such research, and examine IRB mechanisms