All Of Us Research Program Returns Results

The U.S. 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. This marks a major milestone for the program, delivering on its promise to share information and return value to participants.

“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. “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.”

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

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.

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 2-3% of participants will receive a result showing a pathogenic or likely pathogenic variant linked in one of the genes in the report. Those whose results show they may have an increased risk of 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. The clinical DNA test will be conducted by Color Health, which provides genetic counseling services to all 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 health care provider and undergo the appropriate clinical testing prior to considering changes to medications.

All Of Us works with a consortium of national and community partners across the United States to help reach people and collect DNA samples and data from surveys, physical measurements, electronic health records (ERHs), and wearable devices. The program’s Data and Research Center, Participant Technology Systems Center, and Genetic Counseling Resource worked closely with the program and other partners to develop the process for returning health-related genetic results. The program’s Biobank and Genome Centers collaborated to generate the genomic data that informs the personalized results.

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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