Wanted: 1 million people to help transform precision medicine: All of Us program open for enrollment
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* Julia Haskins

Too often, biomedical research has suffered from a lack of diversity. People who are among historically underrepresented races, ethnicities, disabilities, health statuses and myriad other identities tend not to be well-reflected in such research, which can create gaps in medical and health care.

Without diverse enrollees, researchers lose out on information. And that deprives many people of the treatment and prevention practices that could help them achieve better health outcomes.

![Figure1](http://www.thenationshealth.org/https://www.thenationshealth.org/content/nathealth/48/5/1.1/F1.medium.gif)

[Figure1](http://www.thenationshealth.org/content/48/5/1.1/F1)

All of Us, a large-scale longitudinal research program coordinated by the National Institutes of Health, is seeking to diversify biomedical research by involving a wide range of participants.

Image courtesy All of Us Research Program

The National Institutes of Health is working to transform the status quo in biomedical research with the All of Us Research Program, an ambitious venture to enroll at least 1 million U.S. adults in the largest precision medicine initiative to date. The program, which officially launched May 6, seeks to expand precision medicine — medical care and prevention that explore the genetic, lifestyle and environmental influences on health — by including a more representative sample of Americans.

“There is a tremendous opportunity to be gained from more personal, personalized preventive health, and also treatment that really takes into account each of us as unique individuals,” Dara Richardson-Heron, MD, chief engagement officer and scientific executive for All of Us, told *The Nation’s Health.*

In 2015, President Barack Obama announced the Precision Medicine Initiative, which has an objective of enabling “a new era of medicine through research, technology and policies that empower patients, researchers and providers to work together toward development of individualized care,” according to the mission statement.

While the Precision Medicine Initiative’s short-term goals focused on cancer research, All of Us fits into its long-term goals of scaling up precision medicine across health care. To broaden the reach of precision medicine, the program requires the participation of everyone, including people who are not regularly included in biomedical research.

With a program as wide-scale as All of Us, research and public health may be able to better understand the factors that contribute to health disparities among marginalized groups, and work toward equity in health care delivery and access. APHA member and All of Us advisory panel member David Williams, PhD, MPH, stressed that precision medicine is not a panacea, but it does have the potential to promote improved access to quality care for at-risk populations.

“It is one component of the kind of efforts we need as a society to ensure that everyone gets the appropriate care and gets access to the opportunities that drive and support good health,” Williams, the Florence Sprague Norman and Laura Smart Norman professor of public health at the Harvard T.H. Chan School of Public Health, told *The Nation’s Health*.

All of Us will be collecting a large amount of data from participants, which may include physical measurements, biosamples such as blood or urine and information from wearables and digital apps, depending on what people choose to contribute. Participants may also be asked to provide access to their electronic health records. While voluntary, handing over such private data raises alarms for some, a concern that All of Us recognizes.

“We’re asking people to share the most personal information that you could possibly share about yourself, and that includes your DNA,” said Steven Steinhubl, MD, director of digital medicine at Scripps Translational Science Institute, which is managing enrollment of volunteers who sign up on their own.

![Figure2](http://www.thenationshealth.org/https://www.thenationshealth.org/content/nathealth/48/5/1.1/F2.medium.gif)

[Figure2](http://www.thenationshealth.org/content/48/5/1.1/F2)

Photo courtesy All of Us

All of Us has a number of safeguards in place to ensure participants’ privacy, according to the program. Data are encrypted and direct identifiers of participants are removed. There will be a public database that can be used to look at larger trends among participants, but will lack information on individuals. A controlled scientific database will include individual-level information that researchers, who must adhere to a code of conduct, can use with permission from the All of Us Resource Access Committee. In addition, participants can refuse any activity and withdraw from the program at any time.

Privacy is not the only concern that has come up in the rollout of All of Us. The program must contend with a long history of abuse in biomedical research toward marginalized groups — the same people that All of Us wants better represented.

There are countless examples of such offenses, from the exploitation of black men in the U.S. Public Health Service Syphilis Study at Tuskegee to the non-consensual and uncompensated use of cells from Henrietta Lacks to children with intellectual disabilities infected with viral hepatitis as part of vaccine research at the Willowbrook State School in Staten Island, New York. Violations of trust and bodily autonomy have led some groups to fear biomedical research, and it is a hesitancy that All of Us is addressing.

“We acknowledge and understand that these unfortunate events have led to hesitancy, and even a refusal of some people, to even consider participating in research,” Richardson-Heron said. “What I hope to do is to merely make the case that if we don’t participate in research, and if people from all walks of life don’t participate in research, then you won’t be able to ensure that these populations have the benefit of any new developments.”

APHA Executive Board Vice Chair Ella Greene-Moton was invited to join some of the earliest conversations about the Precision Medicine Initiative and has been a proponent of bringing more underrepresented groups into biomedical research. In conversations with community members, she has encountered skepticism from people who worry that biomedical research will not actually serve them, and may even be harmful. But she also believes that participation offers groups who have been exploited in the past the opportunity to have their voices heard and shape the interventions that will impact their lives.

“It’s about…not just sitting at the table, but being actively involved, asking the questions you need to ask and holding people accountable,” Greene-Moton, community education coordinator at the Center for Public Health and Community Genomics, told *The Nation’s Health.*

## Program partners conducting outreach

One way that All of Us is working to build trust is through its community engagement partners and influencers, which educate people on the program and help them sign up. Groups such as the Asian & Pacific Islander American Health Forum, National Alliance for Hispanic Health and Black Women’s Health Imperative are working to reach their communities with culturally competent engagement practices. All of Us also offers numerous community resources, including videos and handouts, to share with people who want to learn more about volunteering.

Organizations such as APHA and the National Association of County and City Health Officials are also partnering with All of Us to promote the program. APHA member Oscar Alleyne, DrPH, MPH, senior advisor for public health programs at NACCHO, noted the potential for precision medicine to bridge clinical medicine and practice with public health by focusing on both upstream and downstream solutions. For example, a clinician will address diabetes management within the context of individual patients, while a public health practitioner will consider how factors in a community may influence the likelihood a person will have Type 2 diabetes, Alleyne said.

“By expanding the evidence-base to include people from underrepresented populations, we can create much more effective health interventions that ensure equity in our efforts to prevent disease and reduce premature death,” said APHA Executive Director Georges Benjamin, MD, in a news release.

In addition to the many partners working with program volunteers, All of Us aims to treat participants themselves as partners in shaping the program, rather than research subjects. Long-term engagement is a priority for All of Us, with the program planning to continue for at least 10 years. And the longer that people are actively engaged in the initiative, the more data there will be for researchers.

“We believe that the way to keep (participants) engaged and truly feeling like partners is to make sure that we continue to return value to the participant, and that’s going to be different in everybody,” Steinhubl told *The Nation’s Health.*

The program is clear in stating that participants will not gain a direct medical benefit from their involvement. But their engagement could lead to medical discoveries that may help generations of people down the line.

“The real value of participating in research may take years, but just like we’ve all benefited from studies that have taken years…I think our program over the long term will provide many significant advances,” Richardson-Heron said.

For more information and to volunteer to be part of All of Us, visit www. [allofus.nih.gov](http://allofus.nih.gov).

*   Copyright The Nation’s Health, American Public Health Association