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From the Food and Drug Administration
January 6, 1999

Categories of Research Eligible for Expedited Review by IRBs

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JAMA. 1999;281(1):27. doi:10.1001/jama.281.1.27-JFD80012-3-1

The FDA, in conjunction with the Office for Protection From Research Risks, Department of Health and Human Services, has published a notice revising a 1981 list of categories of research that may be reviewed by an institutional review board (IRB) through an expedited review procedure. As before, for expedited review, the specific circumstances of the research must involve no more than minimal risk to human subjects and must appear on the list.

Expedited review consists of a review by the IRB chair or by one or more experienced reviewers designated by the chair, rather than the entire board. Regardless of the type of review—expedited or convened board—the standard requirements for informed consent of human subjects of research remain applicable. The new list, based on a proposal for comment published in November 1997 and revised accordingly, generally clarifies, updates, provides examples, and simplifies the previous listing of categories. Details are available in the November 9, 1998, Federal Register and on the Internet at http://www.fda.gov/ohrms/dockets/98fr/110998b.txt.

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