Engaging Participants as Partners: ELSI Considerations in Large-Scale Precision Medicine Research

To be relevant and impactful, it has become increasingly necessary for researchers to engage stakeholders outside the usual research communities, such as patients and community representatives. Yet, this type of engagement typically occurs in community-based participatory and patient-centered outcomes research, not large-scale genomics or precision medicine research. The All of Us Research Program, which will enroll at least 1 million participants from diverse backgrounds, has committed to actively engaging its participants as partners in all aspects of the program ­– from research design through governance. With guiding principles on privacy and trust and a mission to empower participants, All of Us intends to promote transparency, reciprocity and involvement of participant communities in the governance, oversight, design, implementation and evaluation of the program. This engaged and participant-centric approach represents a substantial shift in large biomedical research initiatives, which until recently had little, if any, public involvement. In this panel, we will discuss lessons learned by the All of Us Engagement Core in developing the infrastructure, tools and resources to meaningfully engage participants as partners. We will highlight important ELSI considerations related to:

1) identifying and selecting a diverse group of participants to engage in governance;

2) effectively engaging participants in these new roles;

3) assessing the impact of participant engagement on the research; and

4) preparing researchers, including those with limited experience in engagement, to work with participants in these roles.

Panelists: Alecia M. Fair, DrPH; Karriem Watson, DHSc, MS, MPH; Elizabeth Cohn, RN, PhD; Consuelo Wilkins, MD, MSCI