Consent Form Reporting on ClinicalTrials.Gov, 2013-2023

Consent Form Reporting on ClinicalTrials.Gov, 2013-2023
Research Letter
Sydney A. Axson, Reshma Ramachandran, Alexa Lisenby, Nicholas A. Giordano
JAMA Open, 21 June 2024; 7(6)
Introduction
Informed consent documentation is legally, ethically, and scientifically imperative for research and provides prospective trial participants key study information. Historically, consent documents have been difficult to obtain and not consistently publicly available. As of July 21, 2019, and after a 2-year voluntary period, the revised Common Rule required select federally funded interventional trials to publicly post consent forms no later than 60 days after the last participant visit. The revision intends to increase research transparency and inform consent development. Although transparency efforts addressing trial registrations and results are well studied, less is known about public availability of consent forms in the context of the revised rule’s recent implementation. This cross-sectional analysis examined National Institutes of Health (NIH)–funded trial consent form availability on ClinicalTrials.gov.