FDA: Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
Description
Under FDA regulations, clinical investigations using human specimens conducted in support of premarket submissions to FDA are considered human subject investigations. Many IVD studies are exempt from most provisions of 21 CFR part 812, Investigational Device Exemptions,, but FDA’s regulations for the protection of human subjects (21 CFR parts 50 and 56) require that informed consent still be obtained from subjects specimens will be used.
FDA believes that it is possible in certain circumstances for IVD device investigations to be conducted using leftover specimens obtained without informed consent while protecting the human subjects who are the source of such specimens. When IVD study sponsors use leftover specimens for which the subject cannot be identified and where results of the investigational test are not communicated to or otherwise associated with the identified subject, concerns associated with privacy are minimized. In addition, these studies do not pose new medical risks to subjects from whom the specimens were originally collected: Any risks from specimen collection were incurred prior to the involvement of the patient as a subject in an investigation, when the specimen was obtained for the patient’s own clinical needs, and no risks from erroneous test results are presented because the results of the testing are not used for clinical management of the subject. Like leftover specimens that have been collected for routine clinical care, the investigational use of leftover specimens previously collected for other research purposes involves no additional medical risk, and privacy risks are mitigated by limiting the applicability of this guidance to specimens that are not identifiable.
Situations When It Is Used
The use of leftover human specimens without obtaining informed consent in an in vitro diagnostic device investigation is may occur if all of the following are true:
- The investigation meets the IDE exemption criteria at 21 CFR 812.2(c) (3).
- The study uses leftover specimens, that is, remnants of specimens collected for routine clinical care or analysis that would have been discarded. The study may also use specimens obtained from specimen repositories or leftover specimens that were previously collected for other research purposes.
- The specimens are not individually identifiable, i.e., the identity of the subject is not known to and may not readily be ascertained by the investigator or any other individuals associated with the investigation, including the sponsor. If the specimen is coded,6 it will be considered to be not individually identifiable if neither the investigator(s) nor any other individuals associated with the investigation or the sponsor can link the specimen to the subject from whom the specimen was collected, either directly or indirectly through coding systems.
- The specimens may be accompanied by clinical information as long as this information does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor.
- The individuals caring for the patients are different from and do not share information about the patient with those conducting the investigation.
- The specimens are provided to the investigator(s) without identifiers and the supplier of the specimens has established policies and procedures to prevent the release of personal information.
- The study has been reviewed by an IRB in accordance with 21 CFR Part 56, except as described in section 7 of this guidance document.
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