NIH’s All of Us Research Program Starts Returning Genetic Health-Related Results to Participants
To help historically underrepresented communities learn more about their health, the National Institutes of Health’s (NIH’s) All of Us Research Program began returning personalized health-related DNA results (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants) to more than 155,000 participants, NIH reported in December 2022 (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants). The reports include information on whether participants have an increased risk for certain health conditions and how they might process certain medications.
“Knowledge is powerful,” Josh Denny, MD, MS, chief executive officer of the All of Us Research Program, said (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants). “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. 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 All of Us Research Program started returning genetic ancestry and trait results to participants in December 2020. The program has returned genetic ancestry and trait results (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants) to more than 175,000 participants and provides about 6,000 results each month. About 80% of All of Us Research Program participants represent communities that have been historically underrepresented in medical research (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants).
The program’s hereditary disease risk report contains information on 59 genes and variants (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants) that are associated with increased risk for (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants) specific cancers, heart conditions, blood disorders, and more. The researchers anticipate that 2%–3% of participants will have a result showing a pathogenic or likely pathogenic variant (https://voice.ons.org/news-and-views/understand-genomic-variants-to-confidently-educate-your-patients) in one of the genes. Participants can also choose to receive a DNA report that includes seven genes (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants) known to affect how a person’s body processes certain medicines.
“Returning information in research programs is the ethical choice, but must be done responsibly and equitably,” Alicia Zhou, PhD, chief science officer of Color Health, the genetic counseling resource for the All of Us Research Program, said (https://allofus.nih.gov/news-events/announcements/nihs-all-us-research-program-returns-genetic-health-related-results-participants). “All of Us is setting a new precedent for longitudinal research programs.”