The National Institutes of Health announced today that national enrollment for its — an ambitious effort to collect demographic, health, genomic, and other data from at least 1 million Americans for use in healthcare research — will open on May 6 for those aged 18 years and older.
To kick off the launch, the organization will be holding community education events in seven US cities, as well as a similar program held online the same day.
“The idea of bringing 1 million people from all walks of life to partner in the research process might have seemed like a pipe dream 15 years ago, but today it is a reality,” NIH Director Dr. Francis S. Collins said during a press event today. “… We didn’t really have the right opportunities in terms of technology and ability to manage large amounts of data. But now we do — the costs of genetic sequencing continues to plummit, EHRs [make] it possible to collect medical information about individuals without having to depend on paper records, which would be utterly impractical for 1 million people. Now is the right time for all of us.”
The All of Us Research Program was established by the White House in 2015, then as the Precision Medicine Initiative Cohort Program. The initiative aims to establish a dataset and research infrastructure that can be used by researchers of various disciplines for years to come. According to All of Us Director Eric Dishman (formerly of Intel), the program’s beta phase has already included 45,000 participants, with roughly 27,000 having already completed the protocol, and over a hundred partnerships spanning 129 clinic locations.
Of note, the program is a conscious effort to collect data on ethnicities and social demographics that may not often be represented in medical research, but are still reflective of the population of the US, Dr. Edith Mitchell, director of the Center to Eliminate Cancer Disparities at Thomas Jefferson University Hospital, explained to Babyforyou.net.ua. Further, because the data collected throughout the course of the program will be made available to the participating individuals, Mitchell said that enrollment could be the first step for many Americans to begin tracking and managing their personal health data.
“This is an opportunity for individuals to actually take charge of their data information and make sure that it is available for personal utilization in terms of their own healthcare,” she said in an interview. “And then [the data] will be available to researchers without the name or other identifying characteristics. It will be de-identified in terms of personal information, and therefore researchers will have the opportunity to group individuals with similar characteristics for research on disease processes or other indicators.”
The basic protocol involves participants viewing informed consent materials designed to illustrate how their data is being used, visits to local participating clinics to be evaluated, and, in some cases, provision of biological samples for use in genomic research. However, the program also announced that it has been exploring the use of data-collecting wearables — such as Fitbit’s devices — to paint a better picture for researchers accessing the data.
“Soon we’ll be offering opportunities for people to share data from their existing wearable devices like fitness trackers, and some health apps coming out soon that are fun to play, but also help researchers collect important data, and then also invitations to pilot new approaches to capturing [EHR] data,” Dishman said during the press event. “This will be a long journey to help both the individuals, but also researchers, get a rich, longitudinal in-depth record about themselves.”
Both Mitchell and Dishman stressed the importance of ensuring the privacy to the program’s long-term success, with the latter promising immediate transparency and other safeguard protocols in place should any types of breaches occur throughout the program.
“Safeguarding participants’ privacy and data are our top responsibility. If we lose that trust, then we lose the viability of the program. Data is only used for research purposes — there’s no selling of people’s data to marketers or advertisers or anything like that,” Dishman said. “We have powerful certificates of confidentiality, thanks to federal law, that helps us protect your identifying information from other government agencies, law enforcement, and legal procedings. We’re using the most advanced commercial cloud-based storage … we’re of course using best practices on standards of cybersecurity [with] experts in government and private sector to inform what we’re doing.”