If 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 an explanation of the purposes and
benefits of the research. (See 21 CFR 50.25.) We recommend sponsors and
investigators consult with the IRB regarding the need for a new informed consent
process in such a case. The IRB decision should include consideration of any state
and/or local requirements regarding informed consent and patient rights. If new
testing could expose the subject to previously unanticipated risks (e.g., privacy
concerns for the subject and/or his family related to testing for a genetic marker),
a new consent may be needed. In addition, if the original informed consent did not
address future research use at all, or did not cover the type of study now under
consideration, it is likely a new consent will be needed.
Under certain circumstances, for human specimens leftover from specimens
originally collected for a previous study, FDA intends to exercise enforcement
discretion regarding informed consent requirements. 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,”
