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  4. Informed Consent – More than Just Another Document to Sign? - 11/08/2024
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Webcast | Virtual

Event Title
Informed Consent – More than Just Another Document to Sign?
November 8, 2024

Scheduled

Date:
November 8, 2024
Time:
2:00 PM - 3:00 PM ET

About

FDA is holding a virtual public webinar on Friday, November 8th from 2:00 pm – 3:00 pm ET on “Informed Consent – More than Just Another Document to Sign?” This event is hosted by the Office of the Chief Medical Officer’s Office of Clinical Policy and the Office of External Affairs’ Public Engagement Staff, both in the Office of the Commissioner.

Individuals who volunteer to participate in clinical research perform a critical role in advancing scientific knowledge. They also support the development of potentially life-saving therapies for patients who need better treatments. The research community has an ethical obligation to ensure that people understand the purpose and the potential risks and benefits of the research before they agree to join a trial. 

This webinar will provide patients and researchers with an overview of FDA’s expectations for informed consent. The webinar will:

  • Give an update on FDA’s efforts to help improve informed consent materials so that they are more understandable for participants;
  • Recommend how informed consent can be presented in a clear, comprehensible way; and
  • Discuss how revised consent can help individuals make an informed decision on whether to join a clinical trial.

Objectives:

  • Discuss the purpose of informed consent in FDA-regulated clinical trials
  • Address information included in an informed consent document and oral discussion
  • Review FDA’s expectations for the informed consent process

Speakers include:

Ann Meeker-O’Connell, MS, Director, Office of Clinical Policy
Suzanne Pattee, JD, Regulatory Counsel, Office of Clinical Policy

Registration:

This event is free and open to the public. However, registration is required and open until the meeting starts.

Date: Friday, November 8th, 2024

Time: 2:00 PM – 3:00 PM ET

Location: The webinar will be held via Zoom. 

Ask Us a Question: Registrants can submit questions for speakers on the registration page and during the event.

Registration

Contact:

Public Engagement Staff, Office of External Affairs (OEA)

Office of the Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Ave, Silver Spring, MD 20993

PublicEngagement@fda.hhs.gov 

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