“Availability of Informed Consent Documents on ClinicalTrials.gov: A 10-Year Review” 

By Sydney Axson, Assistant Professor of Nursing and Research Associate in the Rock Ethics Institute

Abstract: The world’s largest clinical trial registry, ClinicalTrials.gov, was created to provide trial information to the public, clinicians, and researchers. Federal law requires trial information to be presented in a readily understood manner. Over time, content requirements for the site have expanded in scope as access to such content is legally, ethically, and scientifically imperative. The importance of this content requires monitoring and evaluation of clinical trial transparency practices. As of July 2019 the revised Common Rule has required federally funded trials to post consents no later than 60-days after the last participant visit, a disclosure previously voluntary. In this work in progress presentation, I will share preliminary findings on the availability of informed consent documents on ClinicalTrials.gov over time. Informed consent documents have a distinct role amongst clinical trial documentation and represent an important step in making clinical trials more accessible to prospective research participants.