IRB Operations Advanced Track
2019 AER Conference
E23 - Implementing Key Information in Multi-Site Research
Wednesday, November 20
11:30 AM - 12:45 PM
Location: Room 108
David G. Forster, JD, MA, CIP
Chief Compliance Officer, WIRB-Copernicus Group
Jeanne Velders, JD, CIP
Interim Director, Human Research Protection Office, Washington University in St. Louis
Joan Affleck, M.A., M.B.A.
Executive Director, Head of Medical Writing, Merck & Co., Inc.
Speaker(s)
The revised Common Rule requires a concise and focused presentation of the key information at the beginning of the consent form. Many parties, including IRBs, institutions, and sponsors, have proposed templates for key information. This session will compare the various templates as well as any available agency guidance. During this session, speakers and attendees will:
Learning Objectives:
- Review the requirement for key information
- Compare and contrast templates for key information
- Discuss best practices for key information, especially for multi-site research