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All of Us Research Program Begins Returning Genetic Results to Participants

The National Institutes of Health’s All of Us Research Program has begun returning personalized health-related DNA results to more than 155,000 participants, with reports detailing whether participants have an increased risk for specific health conditions and how their body might process certain medications.

The program started returning genetic ancestry and trait results to participants in December 2020. So far, the program has offered genetic ancestry and traits results to more than 175,000 participants and continues to return about 6,000 results each month.

In this first phase of returning health-related DNA results, participants who provided a blood sample and consented to receive genomic information are being individually invited to receive their results. They can choose which health-related results they want, if any. Those who choose to receive results will get an alert several weeks later when their results are ready. Additionally, genetic counselors are available to meet with participants and their family members or health care provider to discuss and interpret their results.

“Knowledge is powerful. By returning health-related DNA information to participants, we are changing the research paradigm, turning it into a two-way street – fueling both scientific and personal discovery that could help individuals navigate their own health,” said Josh Denny, M.D., M.S., chief executive officer of the All of Us Research Program, in a statement. “This type of partnership with our participants is crucial for building trust and fulfilling the commitment we made to drive research that can offer meaningful insights for all.”

The program’s Hereditary Disease Risk report, informed by recommendations from the American College of Medical Genetics and Genomics, includes 59 genes and variants that are associated with serious, medically actionable health conditions. These genes are linked with an increased risk of specific cancers, heart conditions, blood disorders, and more. The program anticipates that 2 to 3 percent of participants will receive a result showing a pathogenic or likely pathogenic variant linked in one of the genes included in the report. Those whose results show they may have an increased risk of a serious health condition will be offered a clinical DNA test through the program’s genetic counseling resource, conducted outside of the program at no cost. This clinical DNA test will be conducted by Color Health, which provides genetic counseling services to All of Us participants.

Participants can also choose to receive a Medicine and Your DNA report that includes seven genes that are known to affect how the body processes certain medicines. Nearly all participants will learn more about how their bodies process medicines based on these results; however, participants are advised to consult a healthcare provider and undergo the appropriate clinical testing prior to considering changes to medications.

“Our participants care about their health as well as medical research. We strive to share information with them in a responsible, accessible, and impactful way that honors their trust in us and provides them with tools to continue to learn more about their own health,” said Karriem Watson, D.H.Sc., M.S., M.P.H., the program’s chief engagement officer, in a statement. “This intentional focus brings us one step closer to advancing health equity for our participants and can serve as a catalyst for change to increase representation in medical research.”

All of Us aims to partner with at least 1 million people who reflect the diversity of the United States to accelerate medical breakthroughs. About 80 percent of All of Us participants represent communities that have been historically underrepresented in medical research, and nearly 50 percent of All of Us participants identify with a racial or ethnic minority group.

The program plans to increase the number of participants who are invited to receive genetic health-related results throughout 2023, including new participants who join the program.

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