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Categories of Research Eligible for Expedited Review by IRBs
JAMA. 1999;281:27.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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 reviewexpedited or convened boardthe 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 . . . [Full Text of this Article]
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