An Innovative Simulation-based Community-engaged Intervention for Training Research Assistants in Culturally Appropriate Informed Consent.

Background: Enrolling under-represented groups in biomedical research remains challenging owing to limited health literacy, historic medical abuses, and mistrust. Addressing such barriers requires scrutiny of informed consent processes and training of research assistants (RAs). Applying simulation methods that are well-established in medical education, Simulation-based Community-engaged Research Intervention for Informed Consent Protocol Testing and Training (SCRIIPTT) engages community members as community advisors (CAs) to train RAs in implementing culturally appropriate approaches, such as addressing difficult issues related to race and power dynamics, into the informed consent training process.

Objectives: To present SCRIIPTT's development, implementation, and preliminary findings.

Methods: Over 12 months, our community-academic partnership 1) introduced SCRIIPTT to the greater community using the Truth & Reconciliation Model, which acknowledges the wrongs of research and offers an apology; 2) deepened understanding of community concerns; 3) developed the intervention; 4) conducted a pilot; and 5) disseminated findings.

Results: SCRIIPTT included a comprehensive training manual, scenarios for simulated informed consent encounters, and a 37-item checklist to measure performance. Outcomes include CA and RA satisfaction surveys, and RA performance rating. The checklist adequately measured observable behaviors. RAs reported important gains in knowledge, self-confidence, and cultural competence in conducting informed consent. CAs reported positive experiences, being fully engaged and valued as members of the research team and participants during simulation encounters.

Conclusions: This pilot study demonstrated the feasibility of SCRIIPTT, with preliminary evidence of effectiveness and acceptability. SCRIIPTT offers an innovative approach for community engagement in research training and advancing the skills of RAs in culturally appropriate informed consent.