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2023 PRIM&R Annual Conference

Informed Consent

IRB Basics

E03 - [IN-PERSON/RECORDED] Key Information Sections Four years In: Where Are We and Where Should We Be Going?

Tuesday, December 5, 2023
4:00 PM – 5:00 PM ET
Location: Ballroom AB
Live Session Recorded Human Subjects Research Call for Session Proposal Deep Dive Series CIP Accredited
This session will be offered in-person and recorded for on-demand access by in-person PRIMR23 attendees registered for this day, and PRIMR23/SBER23 Virtual Meeting registrants.

As of January 2019, all consent forms for federally funded studies must have a key Information section containing elements aimed at increasing participant understanding and assisting decision-making. There has been significant uncertainty and debate in the research community over what exactly Key Information sections should include and look like, which remains relevant in light of the FDA's recent proposal to mirror the Key Information requirement for FDA-regulated research. In this session, speakers will present the results of empirical research characterizing actual Key Information sections as they are found on consent forms posted to ClinicalTrials.gov, and present recommendations on how to improve Key Information sections and best practices for writing and reviewing them.

Learning Objectives:

  • Understand the regulatory requirement for Key Information sections and what the Common Rule and other regulatory documents say about the sections to date
  • Review the results of empirical research characterizing Key Information sections as they are found in consent forms posted to ClinicalTrials.gov across several axes, including length, readability, and topics included
  • Explore a set of empirically-informed recommendations for best practices concerning the writing and IRB review of Key Information sections