Are You Prepared? FDA’s Proposed Rules to Modify Protection of Human Subjects and IRB Oversight

FDA recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs). If finalized, the proposed rule would significantly (but not fully) harmonize FDA regulations for the protection of human subjects (21 C.F.R. Part 50) and IRBs (21 C.F.R. Part 56) with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) that came into effect in 2018. Pharmaceutical and medical device companies should be aware that the proposed rule would revise important requirements for informed consent and disclosures to potential human subjects. In addition, the proposed rule would revise the Agency’s Investigational Device Exemption (IDE) regulations (21 C.F.R. Part 812). The proposed rule would enable major changes in IRB oversight and processes related to FDA-regulated clinical investigations. In addition, FDA issued a separate companion proposed rule that would require use of a single IRB for multisite clinical investigations.

We will discuss the implications of the key changes that are proposed including:

– The new mandatory introductory section of informed consent;

– New elements of informed consent, including whether the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether or not the subject will share in the commercial profit;  

– When an IRB may waive use of a form for documentation of informed consent and situations where an IRB’s continuing review of research, after initial approval, will not be required;

– Benefits and challenges of the proposed rule that would require use of a single IRB for review of multisite clinical research in the United States.   

For questions, contact Becky Bowen at bbowen@kslaw.com

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King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida and New Jersey. We will apply for credit in Colorado, North Carolina and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly admitted and experienced attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias at garias@kslaw.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.

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