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Consolidate Human Research Oversight under Regional Ethics Boards, NIH Clinical Bioethics Department Proposes

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Natalie A. Ochs of Washington Fax reported on September 17 that the National Institutes of Health (NIH's) Department of Clinical Bioethics (DCB) was circulating a human subjects oversight proposal at the NIH. The proposal was designed to dramatically restructure the nation's current human research subjects protection system by extending federal regulations to all human research and replacing local Institutional Review Boards (IRBs) with Regional Ethics Boards (REBs). The plan would incorporate measures designed by various federal agencies to reform the system, including accreditation, credentialing of IRB professionals, legislative action, quality improvement programs, and the creation of a central IRB. The proposal was drafted for the President's Council on Bioethics meeting September 12 by DCB Chief Ezekiel Emanuel; Christine Grady, who heads DCB's Section on Human Subjects Research; and collaborator Anne Wood.

Each of the 10 proposed REBs would consolidate all human …

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