ELSIcon2022 Paper: Navigating community engagement in clinical trial research

ELSIcon2022 • Paper • June 1, 2022

Mikaella Caruncho, Jennifer James, Galen Joseph

In recent years, community engagement approaches to genomic research have grown in popularity, motivated by a range of factors including instrumental goals of increasing diversity among trial participants and meeting funder requirements, as well as ethical concerns about advancing equity. Yet, as community engagement is often siloed as its own form of research, inclusive processes may be sidelined in favor of other research study design priorities. The WISDOM trial is an online, pragmatic RCT testing a risk-stratified approach to breast cancer screening using genomics. Using WISDOM as a case study, we will examine efforts to adopt community-engaged practices late in the accrual process and the tensions between these practices and existing trial infrastructure. Our mixed methods embedded ELSI study of the WISDOM trial includes observations of study working groups and interviews with study staff, participants, and community advisory board members. This presentation will elucidate the complexities of engaging historically underrepresented communities, highlight motivations of various stakeholders, and examine institutional and systemic barriers to fostering meaningful collaboration. Our research raises questions such as: How do different stakeholders conceptualize the practice and value of community engagement? What level of engagement should be implemented and at which timepoints of a study? Should community engagement be mandatory for all genomic research? This presentation aims to spark discussion on the ethical considerations of community engagement in clinical trial research, and how to achieve broader transformations of inclusive research
policies.