The U.S. Government Wants 1 Million People to Volunteer Their Genetic Data
The National Insitute of Health (NIH) said yesterday that it’s finally launching All of Us, a huge research study with the aim of making precision medicine available to people of all backgrounds.
First announced by President Barack Obama back in 2015, participants would volunteer by submitting their medical records to the NIH, or via their doctors. In addition, they would fill out online surveys about their lifestyles, and provide blood and urine samples, as well as be having their genome sequenced.
Both researchers and the public could apply for access to the anonymized patient data, to get insights on how our individual differences affect health and disease risk.
Three years later, the project is finally officially being launched. Up until now, about 26,000 volunteers have provided blood and/or urine samples and filled out surveys about their lifestyle. No genomes have yet been sequenced though, instead, federal workers and clinic partners have enrolled “beta testers” in a pilot phase.
NIH has funded more than 100 organisations from community groups to health centres, academic medical centres and private companies to carry out the program. These organisations have collaborated to develop the program’s protocol and technology systems, to engage diverse communities, to enrol participants and to securely gather and store participants’ information and biological samples for use in research.
This week is when the official enrollment begins. On May 6th, any U.S resident aged 18 or older can sign up. The project doesn’t only seek to harness the power of big data, it also promises participants access to their own information and summarised data from across the program.
“The All of Us Research Program is an opportunity for individuals from all walks of life to be represented in research and pioneer the next era of medicine,” said NIH Director Francis Collins. “The time is now to transform how we conduct research—with participants as partners—to shed new light on how to stay healthy and manage disease in more personalised ways. This is what we can accomplish through All of Us.”
In addition, the NIH has said it plans to notify participants if they have certain genetic variants linked to specific health problems. But after it was revealed last week that police had used public DNA databases to identify the ‘Golden State Killer’, will people still be as keen to share their data?
The program director of All of Us, Eric Dishman, told Scientific American in an interview that all participants are protected by federal law from them [the project] sharing this data with other federal agencies [such as law enforcement].
“… That data—because it was given as part of a research study—is admissible in court, and participants are immune from any consequences it could try to be used for,” he said.
When asking him whether people can back out of the program after being enrolled, Dishman told Scientific American that one can withdraw at any time.
“But obviously if someone has used your data as part of a summary statistic in a study, or run analysis on it and it’s already in publication, we can’t stop that,” he said.
“Moreover, by the time the sample gets to a biobank it has no information on it that would tie it to an individual unless it was sequenced (…), it’s already been “de-identified” at that stage…,” he added.
NIH officials have said in a briefing that they are focusing on gathering health and genetic data from diverse, and historically underrepresented groups. This includes ethnic and sexual minorities, as well as people with disabilities. In addition, they’ll focus on those with less than a high school education, and with income below poverty level.
“That scientific mission of achieving better coverage of underrepresented biomedical research is unique in our program. The diversity of data types we are trying to collect and do over time is different, too,” Dishman told Scientific American.
Giving Back to Participants
The program is also starting a “responsible return of information” pilot later this year. Part of that pilot is an effort to figure out how to get the appropriate educational and counselling resources in place for that group of people.
“We want to make sure there is counselling available to them to receive that information—and then general education and understanding of what that data means, and how it’s different than information you might get from an ancestry service you paid for last Christmas”, Dishman said.
As with all long-term projects, it will take a while before there are any evidence-based studies and breakthroughs from All of Us. “So how do you maintain that trust and importance of volunteering, but manage expectations to make clear that this won’t be about overnight miracles?” Dishman questions.