A randomized control trial of re-designed and shorter research informed consent forms to improve comprehension
The medium-length informed consent form, written at a sixth-grade reading level, with shorter words and sentences, tables, and enhanced formatting, produced significantly better comprehension than longer or shorter informed consent forms. The short informed consent form produced the same level of comprehension as a long informed consent form used in approved clinical trials. Researchers, pharmaceutical companies, and institutional review boards should adopt these informed consent form modifications to increase participant comprehension and satisfaction.
Authors
- Eli Silvert (ORCID: https://orcid.org/0000-0003-0445-4395)
- Merjan Lijerón Ozisik
- Ezekiel J Emanuel
- Samantha Lopez-Rico
Institutions
- University of Pennsylvania (US)
Publication Details
- Journal
- Clinical Trials
- Published
- 2026-03-28
- DOI
- https://doi.org/10.1177/17407745261429936
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00