Madison, Wis. — Participants who donated biosamples via the University of Wisconsin-Madison and UW Health as part of the historic "All of Us" Research Program, may soon see a return of their genetic results.
The National Institutes of Health (NIH), which leads the "All of Us" program, has begun returning genetic ancestry and trait information to its research volunteers. Health-related results will be available at a later date.
"This is an incredibly important milestone in this groundbreaking program," said Dr. Elizabeth Burnside, co-principal investigator, "All of Us" – UW-Madison and a UW Health physician. "Our many participants have selflessly contributed to the ‘All of Us' mission of a healthier future, so it's exciting to see the program begin the process of providing genetic information back to them."
As part of its core values, the program is committed to ensuring that participants have access to their own information, and many participants have expressed a strong desire to understand what their DNA can tell them.
To return genetic information, the program developed a robust informed consent process, giving participants information and choice about whether or not to receive results and to select which results they want to get back. The program also provides access to genetic counselors to help answer questions from participants and their health care providers.
"All of Us" is taking a phased approach to the return of genetic results and will offer additional results over time. In about a year, the program plans to begin offering participants the option to receive information about how their DNA may affect their body's response to certain types of medicines (pharmacogenetics), and about genetic variants associated with the increased risk of certain diseases, based on guidelines of the American College of Medical Genetics and Genomics. Participants will receive information back as their DNA samples are processed, so not everyone will receive information immediately.
Since "All of Us" opened enrollment nationwide in 2018, more than 270,000 people have contributed biosamples and more than 80 percent come from communities that are historically underrepresented in biomedical research. These include racial and ethnic minorities, sexual and gender minorities and other groups.
"We're heartened that so many members of diverse communities have placed trust in this program, so we're incredibly pleased that the NIH has begun the process of providing something of great personal value in return," said Dr. Dorothy Farrar-Edwards co-principal investigator, "All of Us" – UW-Madison. "Looking ahead, our hope is 'All of Us' will help provide important answers as to why some communities are more adversely affected by any number of diseases, including COVID-19."
"All of Us" plans to begin making genetic data available to researchers in about a year, with strict privacy and security safeguards in place to protect participants' information. The program seeks to engage researchers from diverse backgrounds to undertake a wide range of studies and learn more about how to tailor care to people's different needs.
The "All of Us" Research Program is working to build a diverse community of 1 million or more participant partners across the U.S. to help researchers learn more about how genetics, environment and lifestyle factors affect health outcomes. Participants share information in a variety of ways, including surveys, electronic health records, biosamples (blood, urine and/or saliva) and more. Data is stripped of personal identifiers and made available for research through the "All of Us" Research Hub.
UW-Madison, which has teams on the ground in Madison and Milwaukee, joins Gundersen Health System, Marshfield Clinic and the Medical College of Wisconsin in a Wisconsin consortium tasked with enrolling participants statewide. UW Health is a key partner, assisting UW-Madison with recruitment and enrollment efforts in the Greater Madison area.