Talk Regulatory & Compliance track
FDA's Latest Guidance on Informed Consent: Reading Between the Lines
Sat, Apr 26, 2025 · 3:15–4:15 PM CDT Hyatt Regency New Orleans
About this session
The U.S. Food and Drug Administration's (FDA’s) recent guidance for institutional review boards on informed consent was the first update to the old “information sheets” on the topic in nearly 20 years. The Office for Human Research Protections beat FDA to the punch with new consent form requirements, but does the latest guidance mean there is a new “reasonable person” in the room? In this session, we will break down the new FDA guidance and what it means for accredited Human Research Protection Programs. Some organizations may not need to make any extensive changes, but there are differences between the FDA guidance and the expectations of the Common Rule concerning informed consent that must be considered.
CEU: 1.00 ACRP
