The Food and Drug Administration (FDA) has concluded a nine-year drafting process, finalizing its guidance on informed consent for sponsors, institutions, IRBs, and investigators, reported by Hogan Lovells on JD Supra. This culminates a process that began in 2014 and builds upon the FDA’s own 1998 final guidance.
This new guidance, titled “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” goes beyond its predecessor, providing additional examples and illustrations. The extended scope serves to make clear the duties of key players in the research process towards gaining valid informed consent.
The broader detail and clarity of the finalized guidance echo the imperative of informed consent within the process of clinical trials. It emphasizes that informed consent is not merely a regulatory requirement but forms the fundamental base for ethical research involving human subjects.
The guidance underscores that the obligation to obtain informed consent goes beyond the point of initial agreement and continues throughout the study. For instance, new information that may affect a participant’s willingness to continue in the trial should be promptly disclosed.
This significant development serves as a pivotal reference for those engaged in clinical research, particularly Institutional Review Boards (IRBs), investigators, and sponsors, but it is also of relevance to legal professionals in the field. Whether advising corporate clients sponsoring clinical trials or advocating for individuals involved in such research, this final guidance shines a light on the path of compliance with informed consent requirements.