Optimizing Informed Consent—A Call to Action

Optimizing Informed Consent—A Call to Action

Viewpoint

Nancy E. Kass, Ann Meeker-O’Connell, Stephanie R. Morain, Matthew A. Crane

JAMA Health Forum, 2 May 2025; 6(5)

Excerpt

People who volunteer to participate in clinical trials regulated by the US Food and Drug Administration (FDA) play an integral role in advancing scientific knowledge about medical products. These clinical trials are intended to generate reliable evidence that informs product development and, ultimately, patient care—an essential task given the vast gap in evidence for clinical care.1 When implementing clinical research, investigators should provide information about a planned trial to potential participants in a clear, comprehensible way, both out of respect for the individuals who consider volunteering and so that those individuals can make informed decisions about whether they wish to volunteer.

…, we intend to identify additional ways to improve how the research community designs and obtains informed consent, in partnership with potential research participants, researchers, and others in the clinical trial and clinical practice communities… We also plan to continue supporting the research community in applying recommendations from our guidance or appropriate alternative approaches to improve informed consent, including through future demonstration projects that provide examples of clear, understandable, and informative consent documents and processes. Finally, given the multiregional nature of clinical trials, we are working with global partners—in partnership with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use—to promote the comprehensibility and brevity of informed consent. We hope that a strategic and collaborative focus on informed consent will help to fulfill this fundamental ethical commitment to potential research participants.