August 1998 Bulletin

IG finds IRB needs more accountability

The Institutional Review Board (IRB) system has not kept pace with the dramatic changes in research and medicine, according to a government study that found a "brittle system and even a few cracks."

The IRB system is rooted in trust, but it has important responsibilities and authorities for verifying intended human-subject protections are being provided, said George Grob, Deputy Inspector General for evaluation and inspections Department of Health and Human Services (HHS). In testimony to the Human Resources Subcommittee, House Government Reform and Oversight Committee, in June, Grob said IRBs conduct minimal continuing review of approved research; IRBs review too much, too quickly and with too little expertise; and neither the IRBs nor HHS devote much emphasis to evaluating IRB effectiveness. He warned about conflicts with commercial research sponsors.


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