Precision medicine promises to transform the health system by providing patients more individualized prevention and treatment, lowering health care costs, and potentially reducing disparities in health outcomes. This emerging field takes into account individual variability in biology, lifestyle, and environmental exposure and leverages recent advances in technology to integrate clinical, genetic, environmental, behavioral, and social data.
Understanding individual variability means precision medicine must involve people who reflect the full range of age, race, ethnicity, gender identity, geography, and health status. Engaging such a diverse group of people in research may be as challenging as the science of precision medicine and will require new approaches to engagement, including strategies that build partnerships and trust in communities often underrepresented in research.
The All of Us Research Program, a key element of the Precision Medicine Initiative (PMI), will enroll at least 1 million participants and offers an unprecedented opportunity to include the range of biologic, behavioral, cultural, and geographic diversity necessary to advance precision medicine. Like many other aspects of this large, historic PMI program, there is no roadmap for engagement at this scale. In fact, the type of participant and community involvement envisioned for All of Us — participants as partners — represents a substantial change in biomedical research, which, until recently, had little, if any, public involvement.
To prepare for All of Us, I led engagement for the PMI pilot, which was tasked with eliciting input from potential participants in the design of the program. At the forefront of my mind was the need to ensure the program would be truly for everyone, and that the voices of groups often underrepresented would be heard. We designed an approach that prioritized diversity (demographic groups often underrepresented in research) and inclusivity (groups that may have substantial and unique barriers to participating). We identified 16 different groups including racial and ethnic minorities, sexual and gender minorities, older adults, people living in rural communities, individuals with limited literacy, people who are blind, and individuals who are deaf.
More than 5,000 individuals representing all 50 states agreed to participate and helped design the program by responding to surveys, being interviewed, and testing modules that collect lifestyle and behavioral data. To gain deeper perspectives, we also held Community Engagement Studios, face-to-face roundtable sessions designed specifically to obtain feedback from patients and community members in a structured approach that balances the power dynamics between researchers and stakeholders. In less than 6 months, we held 78 Community Engagement Studios in key cities including Miami; Rochester, NY; Nashville; St. Louis; Chicago; New Orleans; Sioux Falls, SD; and Los Angeles. We captured feedback from 654 individuals including 46% racial and ethnic minorities and 9% sexual and gender minorities.
To accomplish this, we didn’t send out flyers or emails announcing that researchers from Vanderbilt and Meharry were coming to town. Instead, we worked with community organizations that recruited and hosted these Community Engagement Studios. Of course, we paid them for their time, but we also asked for their guidance on how to engage their communities and respected their advice. If they said it’s better to have the Studio in the evening or mid-morning, we did. If the organization said their clients would prefer food from a neighborhood restaurant, that’s what we ordered. With their help, we gained input from all of our priority populations including some individuals experiencing homelessness, people who live in the mountains without regular access to Internet, and deaf people who communicated with sign language.
Discovering Unique Needs and Preferences
We learned that while there are similar barriers to participating in precision medicine across the groups, there are unique needs and preferences among some groups, which are likely to be missed if all voices are aggregated. For example, all groups had some concerns about the privacy and security of their data, but more minorities feared financial loss due to others accessing their data. Sexual and gender minorities were concerned that questions wouldn’t allow them to self-identify or wouldn’t fully capture their culture and behaviors. Some Asian Americans wanted to be reassured that their Eastern medicines and holistic therapies would be included. People who are blind or deaf shared that they are rarely asked their opinions about research, and when they are interested in research studies, the exclusion criteria often prevent them from volunteering.
Lack of trust was identified as an important barrier for most groups, and, for some, this was more important than researchers’ prowess or academic affiliation. Given the complexity and newness of precision medicine, groups felt particularly vulnerable and believed the trustworthiness of researchers was paramount.
There was variability in what community members thought would improve trust. Though the cause of distrust was different, both rural communities and Latinos/Hispanics were less trusting of research if the federal government would have access to their data. Individuals who were deaf and sexual and gender minorities worried about eugenics and would be more trusting if researchers with experience working with their communities were involved.
Establishing Trust with Community Partners
I have no doubt that without partnering with community organizations, who lent us their trust, it would have taken much longer to convene the Studios and it’s unlikely that we would have reached beyond the highly motivated, well-connected individuals who are already likely to participate in research. We quickly recognized that these community organizations could do far more for precision medicine than just host Studios. They also can help researchers understand the varied perceptions of risk and trust in communities and help tackle some of the overarching issues that may stall precision medicine, such as limited genomic health literacy. To fulfill these roles, community organizations should be trained, empowered, and resourced as partners in the research. They should be involved in the design of precision medicine programs, not burdened with filling the gaps when researchers fail.
It would be a mistake to take our findings and draw population-specific conclusions, such as African Americans need navigators or older adults prefer phone calls rather than emails. Instead, researchers and clinicians must embrace the bigger picture — there is individual variability in barriers, facilitators, needs, and preferences. Fully realizing the promises of precision medicine for everyone will require cultural humility, a process of self-reflection and honesty to build trustworthy relationships, and precision engagement.
The work reported in this publication was supported by the National Institutes of Health under Award Numbers OT2OD023132 and U54MD010722. The content is solely the responsibility of the author and does not necessarily represent the official views of the National Institutes of Health.