Publication
Published on: August 14, 2023
Published in: Journal of Clinical and Translational Science
Abstract: Barbara Bierer and MRCT Center colleagues Walker Morrell, Ava Glazier, and Deborah Zarin, together with Luke Gelinas of Advarra and Tony Tse of the National Institutes of Health, published Characterization of Key Information Sections in Informed Consent Forms Posted on ClinicalTrials.gov in the Journal of Clinical and Translational Science. The 2018 revised Common Rule requires informed consent forms to open with a “concise and focused” key information (KI) section, but provides no guidance on content or format. Analyzing federally funded treatment trial ICFs posted on ClinicalTrials.gov, the authors found that three-quarters included an identifiable KI section averaging one page—yet readability showed little improvement over full ICFs, and a meaningful minority omitted core content such as the main reasons to join or not join a study. The authors call for consensus-based guidelines to help researchers and IRBs develop KI sections that are both compliant and genuinely useful to participants.
Gelinas L, Morrell W, Tse T, Glazier A, Zarin DA, Bierer BE. Characterization of key information sections in informed consent forms posted on ClinicalTrials.gov. Journal of Clinical and Translational Science. 2023;7(1):e185. doi:10.1017/cts.2023.605
