On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical investigations.
The Final Guidance: (i) summarizes the informed consent process, (ii) outlines and discusses the FDA’s informed consent requirements, (iii) addresses the respective responsibilities of IRBs, clinical investigators, and sponsors for ensuring the informed consent form and process are adequate and meet FDA’s regulatory requirements, and (iv) concludes with a series of frequently asked questions (“FAQs”). Notably, the Final Guidance does not reflect any of FDA’s possible future changes to the informed consent regulations that may be implemented as part of the FDA’s ongoing effort to harmonize its human subject protection regulations in connection with the 2018 Common Rule. FDA expressly leaves open the possibility that FDA may revise this Final Guidance in the future to account for such changes.
As expected, the Final Guidance primarily reinforces the recommendations in the 2014 draft guidance and the 1998 guide. That said, we have highlighted a few noteworthy changes:
- FDA includes new information in the Final Guidance pertaining to coercion and undue influence in obtaining informed consent, with a focus on compensation provided to research subjects. Notably, FDA does not consider the provision of reimbursement for reasonable travel expenses to and from the clinical sites to be a source of coercion or undue influence.
- FDA clarifies in the Final Guidance that, as between clinical investigators and IRBs, IRBs ultimately have the final responsibility for ensuring appropriate disclosures are made to study participants when there are financial relationships or interests that may impact the conduct of the clinical study. Specifically, FDA states, “although the clinical investigators should consider [these] issues regarding financial relationships and interest, IRBs have the final responsibility of determining whether subjects should be provided with information regarding the source of funding, funding arrangement, or financial interests of parties involved in the clinical investigations as part of the informed consent process.”
- The FAQs included in the Final Guidance detail additional considerations for enrolling certain subjects coming from vulnerable populations in clinical trials, including children, non-English speaking subjects, subjects with physical or sensory disabilities, and subjects with impaired consent capacity. These additional considerations include, for example, determining: (i) when parental consent is required, (ii) when translation and interpretation of informed consent information is required, and (iii) how to ensure certain competency requirements are met for enrolling study subjects.
- The FAQs also describe who may serve as a subject’s legally authorized representative and detailed requirements for obtaining informed consent through electronic means.
Clinical research sponsors, IRBs, research institutions, and clinical research service providers should review current informed consent form templates and related policies and procedures to confirm they are consistent with the Final Guidance. Affected parties should watch this space for updates given that FDA indicated further changes may be forthcoming. For questions concerning the Final Guidance, please contact any of the authors or the EBG attorneys with whom you typically work.