IRB Operations Advanced Track
2019 AER Conference
D22 - The Keys to Key Information—An Interactive Workshop
Yvonne Lau, MBBS, MBHL, PhD
Director, Division of Education and Development, HHS OFFICE FOR HUMAN RESEARCH PROTECTIONS
Jerry A. Menikoff, MD, JD
Director, Office for Human Research Protections
Speaker(s)
The requirements for a key information section and for providing information in a way that enhances potential subjects' understanding of why one might or might not want to participate in the research with the goal of making informed consent more meaningful to research participants constitutes a major revision to the Common Rule. This interactive workshop explores OHRP’s thinking about the new requirements for informed consent at 45 CFR 46.116(a)(5), how they could be met, and what might be some examples of best practices. The workshop will focus on biomedical clinical trials, will use case examples for discussion, and provide concrete suggestions for making consent document a meaningful decision tool for participants. During this session, speakers and attendees will:
Learning Objectives:
- Review the new requirements for informed consent at 45 CFR 46.116(a)(5)
- Explore what might be "key information" for potential clinical trial research participants
- Describe best practices and approaches for key information in the setting of clinical trials