Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

The FDA has developed a guidance document that will 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 informed consent regulations under 21 CFR 812.2 (c) (3), for in vitro diagnostic device studies that are conducted using leftover specimens. This guidance responds to an immediate need of the research community. Sponsors that follow this guidance should maintain written documentation demonstrating that they meet the circumstances outlined in the guidance.

The latest form for Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable expires 2022-09-30 and can be found here.