Informed Consent

FDA shares FAQs on IRBs

FDA shares FAQs on IRBs

06/17/2025

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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.

More Time to Comment on Proposed Rule for Waiver of Informed Consent

1/15/2019

The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register November 15, 2018 entitled, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act). Our previous blog details the proposed rule.

Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You: January 29, 2019 Webinar

1/4/2019

Topic: Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You

Date: January 29, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.