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

Speaker:

• James Riddle, MCSE, CIP, CPIA, CRQM, SVP Global Review Operations, Advarra

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The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.