Characterization of Informed Consent Forms Posted on ClinicalTrials.gov

Characterization of Informed Consent Forms Posted on ClinicalTrials.gov
Research Letter
Tony Tse, Sarah White, Luke Gelinas, Walker Morrell, Barbara Bierer, Deborah A. Zarin
JAMA Network Open, 18 November 2021; 4(11)
Open Access
Introduction
Informed consent forms (hereinafter, forms), part of a larger consent process that serves multiple bioethical functions, are intended to provide potential research volunteers with sufficient written information about a clinical trial to help them decide about participation. Despite concerns about their overall quality, broadly generalizable samples of forms have been difficult to access for quality improvement. Since July 2017, ClinicalTrials.gov has allowed voluntary posting of forms for registered studies. Subsequently (January 21, 2019), the revised Common Rule form-posting requirement (45 CFR 46.116[h]) became effective (eAppendix in the Supplement). To explore how access to forms has increased on ClinicalTrials.gov after these initiatives, we sought to characterize registered trials with available forms and posting trends. We also assessed the frequency of form posting by funder type for trials initiated since the revised Common Rule compliance date…
Discussion
As of July 7, 2021, forms were publicly available on ClinicalTrials.gov for nearly 2100 US trials for a range of intervention types and conditions from across 600 mostly nonindustry sponsors. Many of these trials (1243 of 2088 [59.5%]) did not list funding by a US federal agency and, among those 1243 trials, some were initiated before the compliance date, suggesting that their forms were likely not required to be posted under the revised Common Rule. The absolute percentages of federally funded trials initiated since the Common Rule compliance date in set 2 remain relatively low, with fewer than 87 of 529 trials (16.5%) listing a key funder type of “NIH” or “other US federal agency” having posted forms. Although forms for a range of trials are now available on ClinicalTrials.gov, most appear to have been posted voluntarily. Limitations of this cross-sectional study include that retrieved trials were likely skewed toward those required by federal reporting requirements. Trials may have also been miscategorized because of errors or incomplete information in data self-reported by study sponsors. Further research is needed because it is likely too soon to assess the full impact of the revised Common Rule requirement.