Can a human specimen that was initially collected in a study with the informed consent of the subject be used in a later study without a new consent process?
Under certain circumstances, FDA intends to exercise enforcement discretion regarding informed consent requirements for use of human specimens leftover from specimens originally collected for a previous study. See “Guidance for Industry, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration: Guidance on Informed Consent for In Vitro Diagnostic Device Studies using Leftover Human Specimens that are not Individually Identifiable”. If the new study does not fall within the scope of the guidance on leftover human specimens but the original informed consent document contains a statement that excess specimen(s) will be stored for future use in specified types of studies and the new study meets the criteria stated in that consent document, it is possible that no further consent is necessary. This assumes that the original informed consent document contains all of the other essential elements, including notice to the subject that FDA may review their files and a
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