FDA Patient Engagement Advisory Committee Meeting on Patient-Centered Informed Consent
The FDA welcomes participation during the October 30, 2024 Patient Engagement Advisory Committee (PEAC) meeting on patient-centered informed consent in clinical study of FDA-regulated medical products.
Members of the Breast Implant Safety Alliance (BISA) team are planning to attend this meeting. Patient-centered informed consent is an important topic for our advocates. Earlier this summer, members of BISA made a public comment at a related meeting and met with the Federation of American Scientists to help improve FDA Advisory Committees.
According to the FDA, the committee will discuss and make recommendations on patient-centered informed consent in clinical study of FDA-regulated medical products.
The topics for discussion include:
The informed consent process, and
Factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.
In addition to attending the meeting, the FDA encourages interested individuals to register to participate in the virtual breakout discussion.
Meeting Date: Wednesday, October 30, 2024, 10:00 a.m. to 5:00 p.m. ET
Location: Virtual
Registration:
PEAC Meeting: Registration is not required and the meeting is open to the public.
Virtual breakout sessions: Register by October 16, 2024, to participate in the breakout sessions
Request accommodations due to disability by October 23, 2024, by emailing AnnMarie Williams or calling 240-507-6496. If you have questions about this Advisory Committee Meeting, please contact Letise Williams.
RESOURCES
BISA Speaks at Session, Meets with FAS to Improve FDA Advisory Committees
FDA: Patient Engagement Advisory Committee (PEAC) Meeting: Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products on October 30, 2024
FDA: Advisory Committees Give FDA Critical Advice and the Public a Voice
Federation of American Scientists
Learn About FDA Advisory Committees
The Future Of FDA Advisory Committees: Protecting Public Health And Preserving Public Trust
About Breast Implant Safety Alliance (BISA)
The Breast Implant Safety Alliance (BISA) is the largest organization of board-certified patient advocates and subject matter experts in the world dedicated to patient and consumer safety relating to breast implants. Representing the millions of individuals worldwide that currently have, had, or are considering breast implants, the alliance is a non-industry funded leading authority dedicated to providing balanced, evidence-based information for informed decision making about breast implant surgery and related issues. Founded in 2019 by women, BISA is a grassroots nonprofit organization led by volunteers who do not receive a salary for their work.
Contact: Maria Gmitro, President | maria@bisanonprofit.org