Bioethics Blogs

PRIM&R’s Response to the FDA’s Draft Guidance on Informed Consent

by Avery Avrakotos, Education and Policy Manager

PRIM&R has long been committed to the protection of the rights and welfare of human subjects, and strongly believes that informed consent is an essential mechanism for providing potential subjects with the information they need to make considered, autonomous decisions about research participation.

In July, the US Food and Drug Administration (FDA) announced it was seeking comment on a draft guidance document titled “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.” The draft is a substantial revision to the FDA’s prior guidance on this topic, which was issued by the agency in September 1998. Yesterday, PRIM&R’s Public Policy Committee, which is composed of experts from a wide range of disciplines and institutional settings, responded to the agency’s request with a set of comments on the draft guidance.

In its response, PRIM&R commends the FDA for encouraging investigators to think of informed consent as not simply a form, but rather a dynamic process that can be adapted to reflect the unique needs of potential subjects, as well as local context. PRIM&R also thanks the FDA for its efforts to harmonize regulatory requirements and guidance for human subjects research put forward by the Department of Health and Human Services, the Office for Human Research Protections, and the FDA. PRIM&R’s comments also applaud the addition of expanded sections on informed consent with respect to vulnerable populations and the agency’s consideration of the use of new technologies for obtaining informed consent.

PRIM&R comments also identify several areas where further guidance could benefit IRBs, investigators, sponsors, and, ultimately, subjects:

The Consent Form Versus the Consent Process
In a recent blog post, PRIM&R’s executive director, Elisa A.

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.