Adapting a conceptual framework to engage diverse stakeholders in genomic/precision medicine research.

INTRODUCTION: Genomic/precision medicine offers a remarkable opportunity to improve health and address health disparities. Genomic medicine is the study of genes and their interaction with health. Precision medicine is an approach to disease prevention and treatment that considers individual variability in genes, environment and lifestyle. Conclusions from studies lacking diversity may hinder generalizability as genomic variation occurs within and between populations. Historical factors, such as medical mistrust, ethical issues related to decision making, and data sharing pose complex challenges that may further widen inequities in genomic/precision medicine if not appropriately addressed. Although few biomedical studies integrate priorities of community partners into their conceptual framework, effective implementation of genomic/precision medicine research calls for the involvement of diverse stakeholders to expand traditional unidirectional models of engagement in clinical research towards authentic bidirectional collaboration. METHODS: A multipronged approach was used integrating an evidence-based literature review and best practices in developing and evaluating the engagement of diverse stakeholders in genomic and precision medicine research. This was combined with expert consensus building to adapt a conceptual model from a community engagement framework to addressing genomics to be scalable to engagement science, which is challenging to genomic/precision medicine research. RESULTS: The final enhanced conceptual framework is composed of four overarching dimensions now inclusive of domains in trust, exploitation, discrimination, privacy risk, stigmatization, prior harms/injustices, failure to recognize coexisting governments, intersectionality and research transformation. This conceptual framework proposes effective participant research engagement strategies for upstream relationship building, distinct from downstream recruitment strategies in which the goal is enrolment. CONCLUSION: To further shape the evolution of genomic/precision medicine research, it is important to leverage existing partnerships, engage participants beyond recruitment and embrace diverse perspectives. PATIENT OR PUBLIC CONTRIBUTION: In preparation of this manuscript, the perspectives of the community partners on the impact of engaging in genomic/precision medicine research beyond research participation were integrated into this conceptual framework from various guided listening sessions held in diverse communities.

Innovation in Large-Scale Research Programs: Elevating Research Participants to Governance Roles Through the All of Us Research Program Engagement Core.

PROBLEM: Despite the successes of community-engaged research in advancing research relevance and health equity for diverse communities, the impact of this research has been limited to local and regional programs. Engaging diverse community voices in large-scale, national research programs represents a paradigm shift in biomedical research. Still, disconnects remain between research decision makers and the communities they serve, impeding richer, bidirectional engagement. APPROACH: An engagement core team was established within National Institutes of Health All of Us Research Program (AoURP) in 2018 to synthesize community-engaged research practices and establish infrastructure that operationalizes diverse research participant engagement. The authors integrated research participants as "participant partners" within the AoURP governance, an approach that is embedded into the engagement core's 3 aims: (1) integrate a diverse pool of participants into the program, (2) identify and meaningfully engage a cadre of diverse participants into program governance, and (3) assess the impact of such engagement on research. Participant partners are compensated as consultants at approximately $50/hour. OUTCOMES: As of August 2022, more than 515,000 individuals consented to participate in the AoURP, with more than 49% representing racial/ethnic minorities. The authors invited participants to self-nominate if interested in engaging in research working groups, decision making, and governance. Also, consortium partners nominated individuals on AoURP community advisory and/or participant advisory boards to serve as participant ambassadors. Ten individuals were selected as participant partners for the 2022-2025 term. Eight serve on the steering committee; of those, 4 serve on the executive committee; 2 more serve on the advisory panel. An additional 23 serve as participant ambassadors. NEXT STEPS: The authors continue to increase the number of research participants serving as engaged partners in the program. Engagement approaches will be systematically evaluated with the goal of adoption by other large-scale research programs.