A Survey on Including Risks in the New “Key Information” Section of an Informed Consent Form: Where Do We Go from Here?

Authors

• KW Le
• SL Kopka
• DG Chaitt
• JF Pierson
• MC Nason
• TJ Miller

Abstract

The 2018 Final Rule introduces an informed consent form (ICF) section presenting “Key Information” a “reasonable person” needs when deciding whether to join a study, such as the “most important risks.” We asked colleagues what risks should be considered Key Information. We surveyed 3 cohorts involved in human subjects research at NIAID: all primary IRB members, all medical monitors, and a convenience sample of principal investigators (N: 29). The survey presented an ICF Potential Risks section from an IRB-approved study of a monoclonal antibody in HIV patients. It included risk language for the study agent and select study procedures. Respondents were asked to indicate which risks they would move to Key Information. We received 9 responses (response rate: 31%). Of 37 risks, all but 2 were chosen as Key Information at least once (mean risks selected: 12; range: 6–19). Only 7 risks were chosen by at least half of respondents; all were risks of the study agent. The most frequently chosen risks were the study agent’s most common side effects (8 respondents). Seven people included a statement about potential unknown study agent risks. The general side effects of monoclonal antibody infusions were chosen by 80% of IRB members but no other respondents. Although our results highlight variability in viewpoints of research professionals on selecting risks as Key Information, we will use the limited consensuses shown in this survey to develop Key Information. Moving forward, we plan to conduct a related survey in a broader population that includes research subjects.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021