Systematic review of approaches to informed consent in recent high-impact clinical trials

Authors

• Caleigh Propes, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD
• Jonathan D. Casey, Vanderbilt University Medical Center, Nashville, TN
• Matthew W. Semler, Vanderbilt University Medical Center, Nashville, TN
• Stephanie C. DeMasi, Vanderbilt University Medical Center, Nashville, TN
• Amelia L. Muhs, LSU Health Sciences Center - New OrleansFollow
• Edward T. Qian, Vanderbilt University Medical Center, Nashville, TN
• Kevin P. Seitz, Vanderbilt University Medical Center, Nashville, TN
• Stephanie Morain, Johns Hopkins Berman Institute of Bioethics, Baltimore, MD

Document Type

Article

Publication Date

5-15-2026

Publication Title

Journal of Clinical and Translational Science

Abstract

The U.S. Food and Drug Administration (FDA) recently harmonized its regulatory criteria for waivers and alterations of informed consent with the U.S. Common Rule. We conducted a systematic review of clinical trials in the two highest-impact clinical journals in the U.S. to better understand practice-changing trials that are being conducted in the U.S. without prospective written informed consent. One in ten trials in our sample were conducted without prospective written informed consent. Such trials accounted for 93.1% of patient-subjects in our sample, enrolling nearly 3 million individuals. Further guidance would support socially valuable research while ensuring appropriate oversight.

First Page

e94

PubMed ID

42272868

Volume

10

Issue

1

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.

Recommended Citation

Propes, Caleigh; Casey, Jonathan D.; Semler, Matthew W.; DeMasi, Stephanie C.; Muhs, Amelia L.; Qian, Edward T.; Seitz, Kevin P.; and Morain, Stephanie, "Systematic review of approaches to informed consent in recent high-impact clinical trials" (2026). School of Medicine Faculty Publications. 4857.
https://digitalscholar.lsuhsc.edu/som_facpubs/4857
10.1017/cts.2026.10751