Welcome to Project SCORE (Streamlined Consents for Research)! This multi-site trial aims to adapt, implement and test clear, engaging informed consent templates for research studies. We will use mixed-methods conduct this work across three different institutions in the U.S.
The study is funded by the Agency for Healthcare Research and Quality (AHRQ, grant R01 HS029310). Some of the work we are doing to get ready for this project is being supported by Siteman Cancer Center and the Institute for Clinical and Translational Sciences at Washington University in St Louis.
What we know already
Informed consent templates are required to provide clear, transparent information for study participants. However, they often include legal jargon, technical wording, and confusing and repetitive sections. The complex consent process can increase disparities in study participation and thus disparities in study benefits.
What we found in earlier work
The “key information” section of informed consent is meant to ensure that the most important study information is described upfront, rather than being buried within “pages of tables” and “hundreds of risks.” However, new regulations requiring key information do not provide any further guidance on how it should be written or implemented.
We and others have developed suggestions for ways to implement clear, engaging key information to improve informed consent templates and processes. Prior to working with our Institutional Review Boards (IRBs), the key information lengthened and repeated information rather than clarified information about study details.
What we plan to do in this work
To address the gap between what we and others know are best practices for informed consent and the reality of existing lengthy, complex templates, our current study will engage with several university and medical center IRBs and key stakeholders (principal investigators of studies, research coordinators, potential participants) to improve these forms and processes in a way that is feasible, acceptable, and sustainable.