by Elisa A. Hurley, PhD, Executive Director
We all know that designing a mechanism for obtaining valid informed consent is a perennial challenge, but it seems to be receiving special and renewed interest lately.
The United States Food and Drug Administration (FDA) recently released a draft guidance, Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors, for public comment. The draft is intended to replace the FDA’s previous, and much briefer, guidance on informed consent, which dates from 1998. Throughout the new draft guidance, the FDA emphasizes that informed consent involves more than a form, and encourages investigators, IRBs, and sponsors to think of informed consent as a dynamic process that can be adapted to reflect the unique needs of potential subjects, as well as local context.
The introduction to the FDA draft states it plainly:
“To many, the term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form. FDA believes that obtaining a subject’s oral or written informed consent is only part of the consent process. Informed consent involves providing a potential subject with adequate information to allow for an informed decision about participation in the clinical investigation, facilitating the potential subject’s comprehension of the information, providing adequate opportunity for the potential subject to ask questions and to consider whether to participate, obtaining the potential subject’s voluntary agreement to participate, and continuing to provide information as the clinical investigation progresses or as the subject or situation requires. To be effective, the process must provide sufficient opportunity for the subject to consider whether to participate.”
PRIM&R has long championed this approach to thinking about informed consent, and we commend the FDA for recognizing that this guidance document can be used to foster improved understanding of the purpose and goals of informed consent.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.