Basic Track (SBER)
2019 SBER Conference
Basic
B03 - Informed Consent in SBER
Jennifer B. Dier, CIP, CCRP, CHRC
Senior IRB Analyst, UC San Diego
Yvonne Lau, MBBS, MBHL, PhD
Director, Division of Education and Development, HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Linda E. Petree, BA, CIP
Director, HRPP, The University of New Mexico
Speaker(s)
The new informed consent requirements in the revised Common Rule can present a challenge in SBER. For example, it can be tricky to determine when the key information requirement (46.116(a)(i)) is needed in already simplified consent documents. Adding this information can result in unnecessary redundancy of content and added length to the informed consent process, without added value to the subject experience. This session will offer guidance to IRBs and researchers on this, as well as will discuss using flexibility in implementing other common informed consent regulations relevant to SBER (e.g., waivers of informed consent, waiver of documentation, electronic consent). During this session, speakers and attendees will:
Learning Objectives:
- Review the informed consent regulations in the revised Common Rule
- Discuss ways IRBs can navigate the key information requirement
- Offer guidance and strategies for IRBs and researchers for satisfying the informed consent regulatory requirements, including documentation waivers, while ensuring an efficient and concise informed consent discussion