William J. Burman, MD; Randall R. Reves, MD
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Burman WJ, Reves RR. The Crisis in Local Institutional Review Boards. Ann Intern Med. 2002;136:411. doi: 10.7326/0003-4819-136-5-200203050-00021
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Published: Ann Intern Med. 2002;136(5):411.
We are gratified that our paper generated long overdue discussion about the crisis in local IRB function. We hope that the recommendations from the National Bioethics Advisory Commission on human subjects protection and IRB function (1) will promote further discussion and bring about meaningful changes. The Commission clearly recognized the impossible demands on local IRBs in the present system, and their recommendations should improve protection of patient safety while decreasing the inefficiencies in the present system. The Herculean efforts of Dr. Siegel and colleagues to track and interpret the onslaught of adverse event reports from multicenter trials fulfill current reporting requirements but are very unlikely to add to patient safety. The regulations should be changed to clearly place the responsibility for evaluating adverse event reports from multicenter trials on the data center and the data and safety monitoring board.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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