Massive US Study Begins Announcing Gene Findings with Participants

More than 155,000 Americans who shared their DNA with scientists to learn more about genetics will receive the results. On December 13, the National Institutes of Health announced they would start informing study participants of some early findings.

The study was conducted to understand the sequencing behind people's genetics, environmental factors, and personal habits to determine their overall health. If any volunteers carried one or more of the 59 inherited diseases or potential medication complications, the National Institutes of Health (NIH) would begin notifying them.

What is NIH’s research project?

The NIH's program, titled All of Us, is a collaborative research effort to congregate health data from a million or more individuals across the United States for 10 or more years. The study focuses on the environment, biology, and habits of the volunteers.

The program’s goal is to learn how these factors affect health. The study will determine if participants have an increased risk for inherited health conditions or medications, and will aid in the prevention and treatment of certain diseases.

“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 All of Us Research Program Chief Executive Officer Josh Denny, M.D., M.S.

About 80 percent of the project volunteers are from communities that are historically underrepresented in the medical research field, and roughly half of the volunteers fall under a racial or ethnic minority group. All of Us began returning the genetic ancestry results to individuals in December 2020 and has given results to approximately 175,000 participants, with an anticipated return of 6000 results per month.

What are All of Us’ values?

The All of Us research program has set core values to provide the best experience and results. Participation is open to eligible adults who reside in the United States. Currently, the program is only accepting adult volunteers, and children may be included in the future.

According to the NIH, participants are referred to as partners to build a trusting relationship and show the agency’s commitment to the study. “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,” Denny said.

All of Us values transparency, and participants are made aware of how their information is used and shared. Participants can view their information and select what they want others to see.

The group research database is publicized, and anyone can acess the information. Individual research databases are available only if the volunteer consents to allowing the information to be made public. The data is stored on a secure cloud system that meets the Federal Information Security Management Act's criteria and ongoing security tests will be used to protect all participants.

“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 Chief Engagement Officer of the program Karriem Watson.

Alicia Zhou, Ph.D., chief science officer of Color Health, the Genetic Counseling Resource for the All of Us Research Program, said, “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.” She added, "Returning information in research programs is the ethical choice, but must be done responsibly and equitably. All of Us is setting a new precedent for longitudinal research programs.”

NIH plans to expand the project throughout 2023, working with more volunteers.

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