The National Institutes of Health is on track to ultimately recruit a million volunteers as part of the Precision Medicine Initiative’s All of Us research program, according to NIH Director Francis Collins, MD.

“This is a remarkable program on a scale never before attempted in the United States,” said Collins on Thursday during a speaker series in partnership with the National Library of Medicine. “More than 195,000 people already signed up, on the way to a million. That makes it already just about the biggest study that the National Institutes of Health has ever put on—and, we’re just getting started.”

Collins contends that NIH is “on track to achieve our one million participants within a five-year period from the original launch—and, I’m hoping we might even be able to do it a little sooner.” He pointed out that the All of Us research program was officially launched in May 2018, less than a year ago, but a lot has already been accomplished.

Of the 195,000 Americans who have volunteered to date, Collins disclosed that so far more than 117,000 participants have provided blood and urine samples that are being sent to the Mayo Clinic’s biobank in Rochester, Minn., which will store more than 35 million biospecimens and associated data for the cohort.

“As part of this study, people will be having a very detailed analysis of their DNA that’s derived from their blood samples,” added Collins. “We have now brought onboard three of the most advanced genome centers in the country—actually in the world—and they’re our partners in doing this.”

Also See: NIH establishes three genome centers to support PMI cohort

Participants in the All of Us research program will contribute their physical, genomic and electronic health record data to help researchers make medical breakthroughs by measuring risk for a range of diseases based on environmental exposures, genetic factors and interactions between the two.

“Making their electronic health records available is a critical part of this,” according to Collins.

In addition to providing blood and urine samples as well as access to their EHRs, participants’ information will be collected through fitness trackers, physical measurements and surveys.

“There’s a lot of new technologies that have come along, including things like wearable sensors that are keeping track of what’s happening day to day—which can be very valuable in trying to make this study even more powerful,” noted Collins. “If you have a Fitbit, we have asked you to begin to see about ways to share that data with the study. At the moment, it’s Fitbits, but other wearable devices will be coming along. All of this adds greater depth to the study.”

“The opportunity to deal with very large datasets—and also to develop highly secure computer systems—means that this is the right moment to mount a study of this sort,” added Collins. “All of the data will be anonymized before researchers get to look at it.”

Collins emphasized that researchers who have access to the data through the All of Us research program “have pledged they will not try to identify individuals, and they will adhere to this very strong security and confidentiality principle.”

However, an audit released last month by the Department of Health and Human Services’ Office of Inspector General found that NIH does not have adequate controls in place when it comes to permitting and monitoring access to the agency’s sensitive data. HHS Secretary Alex Azar was asked about the OIG report on Thursday during his testimony before the Senate Finance Committee regarding the agency’s fiscal year 2020 budget.

“The OIG report found that NIH did not consider national security risk when permitting and monitoring foreign principal investigators’ access to U.S. citizens’ genomic data,” said Sen. Chuck Grassley (R-Iowa) chairman of the Senate Finance Committee.

“The OIG further noted that NIH permitted access to genomic data to for-profit entities including companies from China, even though the FBI has identified those companies as having ties to the Chinese government,” Grassley added. “The OIG also found that NIH did not verify that foreign researchers had completed information security training.”

Azar responded that NIH recently established a working group to “address how to mitigate these concerns.” He added that the agency is taking the issue very seriously, while acknowledging that it’s an “immense” challenge.

