Contains Nonbinding Recommendations Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Exception from Informed Consent Requirements for Emergency Research U.S. Department of Health and Human Services Food and Drug Administration Office of Good Clinical Practice Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health March 2011 Updated April 2013 Contains Nonbinding Recommendations Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Exception from Informed Consent Requirements for Emergency Research Office of Communication Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714
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