Sustainable Solutions to Translating Best Practices for Informed Consent

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Project Summary/Abstract Current approaches to informed consent hinder rather than help research recruitment. Informed consent templates often include legal jargon, technical wording, and numerous repetitive and confusing sections. The consent process and templates can increase disparities in study participation among racially minoritized populations, rural-residing populations and older adults. Fortunately, we and colleagues have developed tools and recommendations to improve understanding and adoption of evidence-informed practices for consent in clinical trials. Yet these tools and recommendations are not widely used in practice. In this project, we will used mixed-methods to address this gap between knowledge and practice. We aim to: (1) Engage with key stakeholders to improve these forms and processes in a way that is feasible, acceptable, and sustainable; (2) Prepare an improved consent template and process for implementation; (3) Implement and test the consent template and process in three studies (1 per institution at 3 institutions). We will use Expert Recommendations for Implementing Change (ERIC) strategies to ready sites for implementation, focusing on strategies to increase capability, opportunity, and motivation to implement change. A community advisory board will actively engage in the study for its duration to ensure that each step of the process aligns with their needs. Our strong study team has expertise in research ethics, health literacy, health communication, health decision making and implementation science. This study will overcome barriers to translation by providing: (1) A toolkit to facilitate adoption of an evidence-based informed consent template and process, and (2) a national model for participant-centered informed consent, meeting regulatory requirements without overburdening participants or researchers. We will test our intervention’s robustness in different environments with different regulatory systems for research and unique institutional strengths.