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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 p.m. - 3:00 p.m. ET

About

The FDA held 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 was 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 provided patients and researchers with an overview of FDA’s expectations for informed consent. The webinar:

  • Provided an update on FDA’s efforts to help improve informed consent materials so that they are more understandable for participants;
  • Recommended how informed consent can be presented in a clear, comprehensible way; and
  • Discussed 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 included:

Lana Maria Escamilla, JD and clinical trial participant
Ann Meeker-O’Connell, MS, Director, Office of Clinical Policy
Suzanne Pattee, JD, Regulatory Counsel, Office of Clinical Policy

Recording

Recording

If you have questions about informed consent in clinical trials, please contact GCPQuestions@fda.hhs.gov. If you have questions about this webinar, please contact PublicEngagement@fda.hhs.gov
 

Event Materials

Title File Type/Size
Informed Consent Transcript 11182024 pdf (285.70 KB)
Informed Consent slides 11182024 pdf (5.49 MB)
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