2023-2027 Streamlined Consents for Research (Project SCORE): AHRQ R01 HS029310

Informed consent documents are often lengthy, difficult to understand, or redundant. Many informed consent templates exceed their own readability standards. Few include short summaries, white space, bullets, or graphics, and participants often lack basic knowledge of important research concepts, including randomization, study risks, right to refuse participation, alternatives to treatment, and risks from participation. Complex consent forms can reduce understanding, increase participant concerns, and lead some participants to decline participation.

This study, Project SCORE (Streamlined Consents for Research) will develop and test visual templates for the key information section of informed consents. The study will test the template’s feasibility, acceptability, and appropriateness across three participating institutions (Washington University School of Medicine in St. Louis, University of Utah, and University of North Carolina—Chapel Hill).

This research is supported by the Agency for Healthcare Research & Quality, SIteman Cancer Center, and the Institute for Clinical and Translational Sciences. This project is led by Dr. Mary Politi with collaboration from Dr. Ashley Housten, Dr. Jessica Mozersky, Dr. Angela Hill, Dr. Kim Kaphingst, Dr. Erin Rothwell, and Dr. Clara Lee.

Publications

Cooksey KE, Goldstein E, Lee C, et al. Qualitative Assessment of Proposed Visual Key Information Pages for Informed Consent. Journal of Clinical and Translational Science. Published online 2024:1-24. doi:10.1017/cts.2024.662