National Institutes of Health has $1.5 billion of federal funding to help participating health networks collect and submit genetic data from their patients

Many of the nation’s most prominent health networks and hospitals signed up to participate in an ambitious genetic research project organized by the National Institutes of Health (NIH) and supported by more than one billion dollars in funding from the federal government.

The NIH wants to gather genomic material from one million people to investigate numerous medical conditions. Health networks and hospitals have been invited to refer their own patients to participate. While some are being paid tens of millions of dollars to participate in the initiative, how this project will influence the development of clinical services that incorporate precision medicine and genetic medicine has yet to be determined.

Known as the “All of Us Research Program,” the NIH project, budgeted at $1.5 billion, aims to gather the genomic data of at least one million people. Participants are providing genomic material from blood and urine samples, along with supplementary data from their electronic health records (EHRs), wearable devices, and personal surveys. Study subjects will have the option to obtain their primary data files.

The initiative suggests a new way to conduct large research projects at a time when precision medicine is swiftly being adapted by providers. “Today, much of our medical care is ‘one-size-fits-all,’ not tailored to the specific needs of the individual patient. If we are to make the biomedical breakthroughs necessary to realize the full promise of precision medicine, researchers need a lot more data that takes into account individual differences in lifestyle, environment, and biology,” said NIH Director Francis Collins, MD, in a recent blog post. As a result, many specimens will be taken from groups that have been traditionally under-represented in research initiatives, such as minorities.

Altogether, 43 hospitals and health networks are initially participating in All of Us. They include:

NIH officials said the network was designed to ensure that genetic data will be collected from a broad diversity of patients. The NIH noted that “additional organizations will be added” in the future.

“Participants will be partners in research, not subjects, and will have access to a wide range of study results,” Collins said. “What we’re doing with the All of Us research program is intersecting with other fundamental changes in medicine and research to empower Americans to live healthier lives.”

The All of Us initiative will initially focus on identifying disease-associated and pharmacogenomic variants in dozens of genes. But in a USA TODAY op-ed published last spring, Collins observed that data from the study would be used to fight diabetes, cancer, and Alzheimer’s disease.

Francis-Collins-MD

NIH Director Francis Collins, MD (above), has said that the All of Us Research Project will break long-standing barriers regarding the subjects who usually participate in large-scale studies and that “every person who signs up for All of Us will be a true partner with NIH in this pioneering effort.” But the NIH has been vague about what the initiative will eventually accomplish, and whether the huge amount of personal data that will be collected will be completely secured. (Photo copyright: National Institutes of Health.)

Hospitals, Healthcare Networks Receiving Related Grants

All of Us is accompanied by cash grants to the participating hospitals and healthcare networks. According to a news release, the Mayo Clinic will receive $142 million over five years to be the primary biobank for the initiative. It will store 35-million specimens in all. The Mayo Clinic doubled the size of its facility in Minnesota for storage/processing and added another 2,000 square feet to its bio-storage facilities in Florida.

To support its biobank function, Mayo Clinic’s Mayo Medical Laboratories will be used to gather and transport specimens from providers around the country. NIH said that the biospecimens will be matched against the demographic and lifestyle information that is collected from those patients whose genetic data will be part of the program.

In Wisconsin, the Marshfield Clinic Research Institute, the University of Wisconsin School of Medicine and Public Health, the Froedtert and the Medical College of Wisconsin, and the BloodCenter of Wisconsin received $60 million in grants to enroll study participants over five years, according to a news release.

The University of Alabama at Birmingham received a $45-million, five-year funding award, according to a news release. As the lead institution in the southern US for the initiative, it is enrolling up to 93,000 participants in Alabama, Louisiana, and Mississippi.

Despite the NIH’s bankroll, there are concerns about what the initiative will eventually capture and make public. The agency has not published any specific goals other than enrollment numbers, and some experts have raised concerns about protecting the data of the participants.

Tiffany Li, a Resident Fellow at Yale Law School’s Information Society Project (ISP), told the Washington Post she was certain there would be some legal ways to access the genetic data of the participants.

Medical experts have also raised concerns about what All of Us may eventually accomplish in terms of moving precision medicine forward.

“What’s going to be their definition of success? Fewer disparities in healthcare? Increased life expectancy? Decreased health costs? It seems a little vague,” Mike Joyner, MD, a Mayo Clinic researcher, told Health News Review.

A similar opinion was expressed by University of Minnesota bioethicist Leigh Turner. “Such a large-scale, high-profile initiative attracts a lot of attention, but that doesn’t mean there will now be an inevitable and swift march toward the development of precision medicine,” he said.

For the moment, most hospitals and health networks participating in the project will focus on identifying test subjects and helping them to enroll. It has yet to be determined if these participating institutions may have additional responsibilities in the coming years.

—Ron Shinkman

Related Information:

Precision Communication for Precision Medicine: How NIH’s All of Us Is Tackling Patient Recruitment

‘All of Us’ Biobank to Store 34-Million Samples for Medical Research

Google Cloud Moves into Medicine with NIH Partnership

National Academies Report: Provide Patients with Clinical Study Results

NIH’s All of Us Research Program Partners with the National Library of Medicine to Reach Communities Through Local Libraries

National Organizations Support Outreach Efforts for NIH’s All of Us Research Program