SYMPOSIA/CONFERENCES/WEBINARS
We will selectively include information on major symposia and conferences which address issues, evidence, analysis or debates involving consent/assent. This listing will include [1] meetings already concluded but which are posting presentations/recordings, etc.; [2] future meetings which have posted registration/logistics information, and [3] meetings which have announced calls for abstracts/panels, etc.
Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products
FDA Patient Engagement Advisory Committee Meeting
Webinar: October 30, 2024
Video recording: [7:13] https://www.youtube.com/live/Th3fkIpi3vc
AGENDA:
On October 30, 2024, the Committee discussed and made 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 FDA has worked to improve informed consent over the years, including several recent activities such as developing a draft guidance in identifying key information in informed consent.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. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting.
Background material and the link to the online teleconference and/or video conference meeting are available at https://www.fda.gov/AdvisoryCommittee….
Briefing Documents providing further information:
Center for Informed Consent Integrity 