Learn eCORE recognizes the importance of improving diversity and inclusion in research. Our courses address these topics and we have discussed this issue in other blogs and on social media.
We recently had the opportunity to speak with Dr. Martin Mendoza, Director of health equity for the National Institutes of Health’s All of Us Program. This blog focuses on our discussion about diversity and inclusion in this program and efforts to enroll people from communities historically underrepresented in biomedical research. We will also be posting a second blog that will focus on the data generated by the All of Us Program and efforts to encourage its use by diverse investigators. Learn eCORE is proud to be a member of the All of Us Community Advocate Network, to support the All of Us program goals, particularly those related to diversity, equity, and inclusion.
Dr. Mendoza, can you briefly introduce yourself and the All of Us Program
Thanks for the opportunity to connect with the Learn eCORE team Ann and Sherry! I actually got my start in research as a high school student working on the Human Genome Project at the National Human Genome Research Institute. After earning a Ph.D. in cancer biology from Johns Hopkins University, I spent time working on clinical trial inclusion and human subjects protections at NIH. I then transitioned to the Food and Drug Administration (FDA) where I led extramural research for minority health and was the primary author for FDA’s first ever guidance document on clinical trial diversity. After FDA, I served as the Director of the Division of Policy and Data in the U.S. Department of Health Human Services’ Office of Minority Health, where I developed policies and initiatives to eliminate health disparities. About a year ago, I brought my research and health equity experience to All of Us to provide leadership for improving the program’s inclusion and diversity efforts.
All of Us was created in 2015 as result of NIH’s Precision Medicine Initiative. The program has a very ambitious goal to enroll one million or more participants from diverse groups historically underrepresented in biomedical research. Participants can choose to share detailed health and lifestyle information, includes blood, saliva or urine samples to create a large, inclusive dataset. Researchers can tap this data to examine the impact of biological, genetic, and lifestyle factors on health. All of Us believes that achieving our goals will help improve individualized health care and provide valuable data on a variety of health conditions.
How does All of Us define diversity, equity and inclusion and how are these relevant to its program goals?
All of Us defines these very broadly. In addition to including racial and ethnic minority participants, All of Us also seeks to include participants with various disabilities, limited health care access, lower educational attainment, those from varying gender identity groups, LGBTQAI+ participants, those from rural areas, and participants across the life span. We also have twin goals of including participants as well as researchers from diverse groups and backgrounds.
This focus on getting participants from groups that have historically been excluded from research is notable. Why is this important to All of Us?
Having a diverse set of participants is central to achieving the program’s mission of creating one of the largest and most diverse health related datasets. Having data from participants who reflect the diversity of the U.S. will enable researchers to conduct a wider variety of research studies with results that are more broadly generalizable. We also hope that specifically encouraging participation from those that normally do not participate widely in research will help build trust in the research enterprise among disenfranchised groups in the U.S.
Can you give us some examples of what All of Us is doing to achieve these ambitious recruitment goals?
Community engagement is one key to our success. To help with our recruitment efforts, All of Us has engaged with many trusted community partners. We have been very intentional in these efforts by identifying specific recruitment needs and partnering with groups that are well-recognized in target communities, such as the American Association on Health and Disability that helped us develop a working definition for disability to ensure that our participants appropriately reflect individuals who identify as disabled. Just looking at our community partners demonstrates our plan for broad recruitment, for example, groups such as the Black Greek Letter Consortium, the National Association of Hispanic Nurses, Asian Pacific Community in Action, FiftyForward, PrideNet, and the National Rural Health Association.
The All of Us Division of Engagement and Outreach oversees the program’s efforts to foster relationships with participants, community partners, researchers, and providers across the United States. This division is also focused on engaging people and populations who have been left out of medical research in the past and inviting them to help drive new biomedical discoveries.
What are concerns people have about participating in research and what are some ways All of Us has tried to address these?
People, particularly those in underrepresented groups, are keenly aware of past abuses in medical research such as the U.S. Public Health Service Syphilis Study at Tuskegee. There is also a general mistrust of the government and a sense that people don’t gain anything from participating in research. Such concerns make individuals reluctant to participate in research. All of Us acknowledges these concerns upfront; we are very clear about risks of participating in research and the ways in which we reduce these risks. We also articulate the benefits of participating in All of Us, such as the return of health-related results and the control we give participants over their data. Our purposeful consideration of concerns has allowed us to develop specific answers to many common questions about participation. We welcome open dialog with potential participants, and we also try not to over promise what All of Us can do. Working with trusted community partners is also quite helpful in addressing concerns and building trust.
Who can participate in All of Us and how have you made participation easier?
Anyone 18 years and older who lives in the US, including its territories, and is not incarcerated can currently participate. Participants do not need to be U.S. citizens. Partly in response to COVID, we have increased remote participation options. We also have a mobile Journey Exhibit that travels the country and can enroll participants on the spot. We allow participants to determine what information they want to contribute, which could include completing online surveys, providing biosamples, such as blood, saliva, or urine, sharing electronic health records, and/or wearable device data.
On the All of Us website, it mentions that the program views “participants as partners”. What does this mean?
Our participants are central to all we do, and we strive to recognize their importance to our program. For example, All of Us shares personal results back to participants. At present this includes genetic ancestry results and some basic traits like lactose intolerance. Starting this winter, we will also provide some health-related results.
Researchers are increasingly aware of the importance of community engagement in developing successful research projects but often are not sure how accomplish this. Can you give us some examples of how All of Us has successfully engaged with diverse communities?
Identifying and building relationships with trusted community partners is key. For All of Us, these community partners will promote our program at the community events and have even accompanied our mobile Journey Exhibit on visits to specific communities. These partners also help us develop culturally appropriate materials and can provide insights into the best ways to explain what All of Us is trying to accomplish.
How can we make researchers aware of the specific concerns of the communities they hope to study?
In general, those involved in clinical research need to be actively involved in community engagement efforts so potential participants can better understand what being in a research study entails and how the research data they provide will be used. They also need to know the potential risks, as well as the benefits of participation.
For example, our program is clear with participants that our main goal is to create a data resource for researchers to advance health discoveries. But we also let potential participants know that we have stringent requirements to help ensure proper use of our data in research. Investigators who register to use the All of Us Researcher Workbench must go through a series of steps to gain access to our data. For example, they must post their plans for using the All of Us data on our Research Projects Directory. They are also required to sign a Data Use Agreement committing to such things as not attempting to identify or contact participants and not conducting stigmatizing research. This helps build trust and comfort in participating with our program.
All of Us was in full swing several years before the onset of the COVID-19 pandemic. How did COVID impact All of Us?
What the pandemic did early on was to shed light on the fact that many disenfranchised and underrepresented communities were the ones bearing the brunt. Those were our friends, our participants, people who work in the community to register potential participants for the program. That’s why one of the very first things we did was to check-in with the community. We sent out a survey to our participants to see how they were being impacted by the pandemic. This survey, called COPE, or the COVID-19 Participant Experience survey, collected responses from more than 63,000 participants, covering topics that include stress, mood, discrimination, social distancing, and economic and work changes, among others. This information amounts to the biggest infusion of mental health data in the program so far.
Not surprisingly, COVID did have an impact on our enrollment. Obviously, we had to pause in-person events, and, like many organizations, we had to adjust our day-to-day operations to a virtual setting – with the understanding that the digital divide impacts a lot of people in this country. Prior to the pandemic, we had established a network of community partners, health care provider organizations across the country. We pivoted from trying to enroll people in person to checking in, calling our participants to see if they needed resources or information. Our community partners took the lead in providing information on local food banks, then when vaccines became available, we provided information, in some situations, transportation. Many of our partners offered test kits.
This year, we did resume some in-person recruitment events and data collection but are retaining a hybrid model to enable enrollment of those who continue to prefer to participate virtually.
Going forward, how will All of Us maintain momentum and continue to expand diversity and inclusion in the All of Us participant pool?
We will soon be enrolling pediatric participants (under 18 years) which means we will have participants from across the lifespan.
We will also be developing partnerships with additional trusted community organizations to continue enrollment efforts and create additional remote participation options. We want to meet people where they are and we are open to anything we can do to enable anyone in the United States to readily participate in All of Us. We will also be continuing our focus on enrolling diverse participants.
Any closing thoughts?
Thanks to Learn eCORE for opportunity to share information about the All of Us Research Program. I am very encouraged about progress the program has made and how it can impact health and promote precision medicine. This effort would not happen without our participants who are true partners in this effort. Everything All of Us is able to accomplish is because of our participants, so I want to acknowledge them as the heart and soul of the program. Lastly, I would like to encourage your blog readers to consider participating in All of Us and in helping to spread the word about this unique research program!
Click here to learn more about becoming an All of Us participant