September 2026 - Grand Rounds 68
Pragmatic clinical trials frequently satisfy the regulatory criteria for a waiver of informed consent for research. Investigators and Institutional Review Boards might thus assume that there is no reason to disclose information about these studies to participants. To assess this approach, this Grand Rounds presentation will discuss reasons to provide information to participants, even when the study does not pose significant risks to them, and their consent for research is not being solicited.
Speaker
David Wendler, PhD
Acting Chief
Department of Bioethics
NIH Clinical Center
Learning Objectives
- Identify reasons to disclose information to research participants
- Consider which reasons apply to research without informed consent
- Evaluate potential concerns with disclosure