11/02/2021
Photo by Trust "Tru" Katsande on Unsplash
The US Food and Drug Administration (FDA) wrote a letter to industry, “Studies Using Leftover, Deidentified Human Specimens Require IRB Review.” It is a reminder to in vitro diagnostic medical device sponsors that Institutional Review Board (IRB) review is needed for clinical trials on leftover, de-identified human specimens. The 2006 FDA guidance “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable” clarifies that informed consent to use leftover human specimens that are not individually identifiable is not required, if it meets exemption criteria from the Investigational Device Exemptions (IDE) regulation (21 CFR 812.2(c)(3)). This guidance states that if enforcement discretion for informed consent is applicable for the clinical trial, the IRB review requirement stands per 21 CFR 56. This is because clinical trials that use human specimens for premarket submissions to the FDA are considered “human subject investigations”, and FDA’s human subject protection regulations (21 CFR parts 50 and 56) apply to all clinical trials regulated by FDA.
In vitro medical device sponsors can review “Good Clinical Practice Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic Device Premarket Submissions” for additional information on requirements.
Do you work with human specimens or with in vitro medical devices? We would love to hear from you! Contact us at info@clinicalpathwaysresearch.com
- The Clinical Pathways Team
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