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NIH seeks health data of 1 million people, with genetic privacy suddenly an issue

NIH Director Francis Collins talks about the 'All of Us' Research Program, a historic effort to gather data from one million or more people living in the United States. (Video: Washington Post Live)

The National Institutes of Health on Tuesday announced the launch of its attempt to enroll 1 million people in a landmark research effort aimed at developing “personalized” methods of prevention, treatment and care for a wide variety of diseases.

The “All of Us” recruitment effort begins Sunday with community events in seven sites around the country, where people will be encouraged to sign up for the mammoth research project. Its goal is to supplement and in some cases replace the need to repeatedly recruit human subjects for research by providing a huge database of health and lifestyle information for scientists to plumb.

The effort comes during a time of intense interest in data privacy. Authorities recently revealed that they had used DNA retrieved from a crime scene and GEDmatch, a website of genetic information, to find and arrest the man suspected to be the Golden State Killer, who terrorized Californians with a series of rapes and homicides in the 1970s and 1980s.

But NIH Director Francis Collins and the project’s director, Eric Dishman, said volunteers’ personal data will be carefully shielded. They noted that Congress expanded protections for federally funded research in the two-year-old 21st Century Cures Act, with an eye on this type of project.

They said the information is off limits to subpoenas and search warrants via “certificates of confidentiality” given to each subject. The rules protect researchers from being forced to release identifying information in judicial proceedings.

“This is something we thought about,” Collins said. “We knew this was going to be an issue in getting people comfortable.”

Tiffany Li, a lawyer and resident fellow at Yale Law School’s Information Society Project, said she is cautious about claims that any database can be completely shielded from access by law enforcement. She noted provisions of the USA Patriot Act that allow access to some health information in intelligence matters.

“I would argue that there probably is some way to access the data,” Li said.

Additional privacy protections included inviting hackers to try to breach the database where the information will be stored, Dishman said, although he acknowledged that no database is 100 percent safe from intrusion.

Personalized medicine, also known as “precision medicine,” is a relatively new approach to treatment that uses genetic and other information to develop therapies targeted at individuals rather than groups of people. It has been most helpful so far in treating some cancers, because gene sequencing has allowed scientists to develop treatments based on genetic mutations found in tumor cells rather than on the part of the body where tumors emerge. Dishman said he is alive today because such an effort saved him from a rare form of kidney cancer.

Collins and others have long theorized that there are many more applications for the approach. After President Barack Obama announced the initiative in his 2015 State of the Union address, NIH began testing the program in 2016.

In the test phase of what Collins said is “among the most ambitious research efforts” ever undertaken, NIH recruited 45,000 people, 27,000 of whom completed all the surveys, supplied information such as height and weight, and gave blood and urine samples. That total is short of the 79,000 Collins said NIH hoped to recruit in 2016.

The project leaders say they hope to reach its goal of 1 million enrolled in five or six years.

Information culled from the project will be available at three levels: some to the general public, some under more tightly controlled circumstances to researchers because of the risk of identifying people participating in the trial, and the rest under the tightest control because of that risk. Participants in the study will have access to their information at all times. Organizers are recruiting only adults but hope to include children later.

The officials who briefed reporters Tuesday emphasized the goal of including people from varying races, ethnic groups, education levels and socioeconomic groups, as well as people with physical and mental disabilities and differing access to care.

Dara Richardson-Heron, the project’s chief engagement officer, called the study a rare opportunity to address the historical disparity in care between whites and racial minorities, as well as a chance to bring underrepresented groups into clinical research, where subjects have long been mostly white and male.

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