Human research will be more equitable, inclusive and stronger if the people who are participants in studies also help plan and guide the direction of those studies.
Since 2017, this form of engagement has been an important part of the national All of Us Research Program, an ambitious effort led by the National Institutes of Health (NIH) to accelerate the prevention and treatment of illness through genomic and precision medicine.
The NIH is supporting these efforts through a $2 million award that may be renewed annually for up to five years depending on budget approval. This award will fund the All of Us Engagement Core, based at Vanderbilt University Medical Center.
“We’re engaging participants in committees and governance groups,” explained Consuelo Wilkins, MD, MSCI, Senior Vice President for Health Equity and Inclusive Excellence at VUMC, and director of the All of Us Engagement Core.
“They’re working alongside the principal investigators of the programs. They’re working alongside NIH officials. They’re on executive and steering committees, where they have voting rights and responsibilities that are equal to everybody else’s,” she said. “We’re not aware of any other NIH programs that have participants involved in this level.”
As part of the expansion, the Engagement Core has brought on two new faculty leads:
- Elizabeth Cohn, RN, PhD, vice president for health equity research at Norwell Health, New York State’s largest health care provider; and
- Melody Goodman, PhD, vice dean for research at New York University, who will lead a participatory evaluation process to guide engagement in precision medicine research.
A major goal is to enroll more children and teens in research. Toward that end, community engagement “studios” will elicit input from the parents of children from three different pediatric age groups (0-5, 6-12 and 13-18 years), and from racially diverse communities.
Youth and family committees composed primarily of adolescents will guide pediatric engagement and the sustained involvement of parents and children in research across the lifespan. These longitudinal studies focus on maintaining and improving health, as well as treating and preventing disease.
“We still don’t know a lot about how to keep people healthy,” Wilkins said. “What does it look like to remain healthy across the lifespan?”
Much of pediatric research has focused on rare or genetic illnesses that show up early in life, she said, and not as much on risk factors for common chronic conditions, including obesity, diabetes and cardiovascular disease, later in life.
Engagement also means increasing diversity, by expanding the inclusion of racial and ethnic groups, gender identities and people from low-income and rural communities who previously have been underrepresented in research.
Diversity is important because studies restricted to limited groups may not be relevant to other populations. “It really is very beneficial to have those voices reflected,” Wilkins said.
Engaging a more diverse group of “participant partners” in guiding research requires a lot of preparation and constant communication.
A three-member team consisting of two engagement liaisons provides the information and resources that participants need to confidently ask their questions alongside other committee members who have doctoral or medical degrees.
Team members are Alecia Fair, DrPH, research assistant professor, Division of Geriatric Medicine; Selena McCoy Carpenter, MEd, senior population/public health manager, Wilkins Health Equity and Engagement Lab (WHEEL); and Kayla Somerville, MPH, WHEEL program manager. All three have extensive experience in health equity, global health and social/behavioral research.
In the past four years, 81 study participants, including 58 from historically excluded communities, have become part of the governance structure of the All of Us program. Eight of them serve on the steering committee and four on the executive committee.
“That’s another reason this expansion is to be celebrated,” Fair said. When Wilkins helped bring health equity and engagement to the All of Us research effort in 2017, “it was a big culture shift and power disruption to make this happen,” she said.
“We’ve had to change some internal policies on how we do the work,” Wilkins explained. “We have people who cannot afford to pay for hotel or airfare (to attend meetings) without having a travel advance.”
It’s all about “making sure these folks are able to shine, express themselves and bring in their input,” she added. Importantly, the team’s consistency and authenticity has helped engender trust among those new to the scientific process and procedures.
Trust “is something I’ve been trying to push for a long time,” Wilkins said. “When people don’t understand it, and they can’t explain it, it’s hard. When there are people like you at the table giving us input and helping to guide the program, it really does look different.”
Engaging Diverse Stakeholders in Genomic/Precision Medicine Research: The All of Us Research Program Engagement Core is funded by National Institutes of Health award funding No. 1OT2OD035980-01. All of Us is a registered service mark of the U.S. Department of Health & Human Services (HHS).