Скачать или смотреть CITC 2024 – D2S06 – Informed Consent: More than just a document

This presentation examined FDA's expectations for informed consent and explored approaches to facilitating participant understanding throughout the consent process. The session covered FDA's Draft Guidance on Key Information and Facilitating Understanding in Informed Consent, providing insights into regulatory requirements and best practices. The discussion offered practical guidance for improving consent processes and ensuring participants receive clear, comprehensible information about clinical trial participation.

Timestamps

01:05 – What is Informed Consent

06:04 – Elements of Informed Consent

12:45 – Informed Consent Development

18:11 – Electronic Informed Consent (eConsent)

22:11 – Key Information and Facilitating Understanding

30:10 – Summary

Speaker:

Ann Meeker-O'Connell, MS
Director
Office of Clinical Policy (OCP)
Office of the Chief Medical Officer (OCMO)
Office of the Commissioner (OC) | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

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