SPOTLIGHT – Upcoming Meeting

The spotlight this month is shining on an important upcoming meeting at the US Food and Drug Administration. On October 30^th the FDA Patient Advisory Committee will “provide recommendations on the informed consent process and the areas of focus of the informed consent” from a patient/trial participant view. The committee will also provide specific recommendations for how the informed consent process be undertaken given these considerations.

The meeting will be open to the public for both observation and participation. We see this as an opportunity to have a real impact in the informed consent policy making space and we invite you to consider participating. We have applied to give oral testimony and will submit written comments as below.

Ways to participate

Interested persons may present data, information, or views, orally or in writing, on issues pending before the Committee, or individuals may participate in virtual breakout scenario discussions

• Written submissions may be made on or before 3 October 2024 to letise.williams@fda.hhs.gov
• Sign up to participate in virtual breakout session on or before 16 October 2024
• Oral presentation requests should be submitted on or before 25 September 2024 [deadline passed]

Patient Engagement Advisory Committee Meeting: Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products
Food and Drug Administration
30 October 2024 [Virtual], 10:00-17:00 EST
Summary
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Patient Engagement Advisory Committee (the Committee).  The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues.  The meeting will be open to the public.
Agenda
     The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.  On October 30, 2024, the Committee will discuss and make recommendations on “Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products.”  The individuals who volunteer to participate in clinical research play an integral role in advancing scientific knowledge and supporting the development of potentially life-saving therapies for patients in need.  Informed consent is a key element in clinical studies and can be one of a patient’s first interactions with the clinical community.  Too often, however, informed consent forms are lengthy and difficult for potential research participants to understand.  FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.
The Committee will provide recommendations on the informed consent process and the areas of focus of the informed consent.  The Committee will also provide recommendations on factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research…

For Further Information Contact: Letise Williams [Letise.Williams@fda.hhs.gov; 301-796-8398] or FDA Advisory Committee Information Line [1-800-741-8138 (301-443-0572 in the Washington, DC area)]