Blog — Clinical Pathways

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FDA Webinar on Improving the Informed Consent Process

FDA Webinar on Improving the Informed Consent Process

02/26/2025

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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.

FDA Informed Consent Final Guidance Finally Here!

08/16/2023

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The US Food and Drug Administration (FDA) published finalized guidance on “Informed Consent” August 2023. It finalized the “Informed Consent Information Sheet” which was previously in draft since July 2014 and supersedes the final guidance “A Guide to Informed Consent” from September 1998. It is applicable for IRBs, investigators, and sponsors.