On August 15, 2023, the U.S. Food and Drug Administration (FDA) published its final guidance on informed consent for Institutional Review Boards (IRBs), clinical investigators, and sponsors. The new guidance, named “Final Guidance”, revises the FDA’s earlier draft guidance dating back to July 2014. The Final Guidance replaces “A Guide to Informed Consent,” the original guidance furnished by the FDA in September 1998.
The Final Guidance release is an essential evolution in FDA’s series of measures aimed at ensuring the ethical and responsible conduct of clinical investigations. Not only does it provide the most current thinking as regards the agency’s interpretation and enforcement of informed consent regulations, but it also reflects industry practices which have evolved over the past two decades and incorporates valuable input from a broad range of industry stakeholders.
Considering the span of almost two decades since the last guidance, this update was due and necessary; not just of the perceived procedural changes in the industry but due to the myriad technological advances that have occurred in the said period. The overarching aim of this Final Guidance is to emphasize the importance of providing prospective subjects with sufficient information to allow a reasoned decision about participation in clinical research.
Despite its non-binding nature, the FDA’s guidance documents are vital to any individual or entity engaged in clinical investigations, offering crucial insight into the agency’s expectations and interpretations of its regulations. While the final guidance does not introduce any radical departures from the informational elements required by the FDA’s past practices, the documentation and procedural aspects of informed consent have become more robust and provide an added layer of protection for subjects participating in clinical trials.
For additional information, a comprehensive analysis of this new guidance can be found in the report by law firm Epstein Becker & Green.