Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff April 2006

GUIDANCE DOCUMENT

• Docket Number: FDA-2006-D-0095
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research, Office of Blood Research and Review

FDA is issuing this guidance to inform sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to exercise enforcement discretion, under certain circumstances, with respect to its current regulations governing the requirement for informed consent when human specimens are used for FDA-regulated in vitro diagnostic (IVD) device investigations. As described below, FDA does not intend to object to the use, without informed consent, of leftover human specimens -- remnants of specimens collected for routine clinical care or analysis that would otherwise have been discarded -- in investigations that meet the criteria for exemption from the Investigational Device Exemptions (IDE) regulation at 21 CFR 812.2(c)(3), as long as subject privacy is protected by using only specimens that are not individually identifiable. FDA also intends to include in this policy specimens obtained from specimen repositories and specimens that are leftover from specimens previously collected for other unrelated research, as long as these specimens are not individually identifiable.

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