NIH Tells Genomic Researchers: ‘You Must Share Data'

August 28, 2014

Scientists who use government money to conduct genomic research will now be required to quickly share the data they gather under a policy announced on Wednesday by the National Institutes of Health.

The data-sharing policy, which will take effect with grants awarded in January, will give agency-financed researchers six months to load any genomic data they collect—from human or nonhuman subjects—into a government-established database or a recognized alternative.

NIH officials described the move as the latest in a series of efforts by the federal government to improve the efficiency of taxpayer-financed research by ensuring that scientific findings are shared as widely as possible.

"We’ve gone from a circumstance of saying, ‘Everybody should share data,’ to now saying, in the case of genomic data, ‘You must share data,’" said Eric D. Green, director of the National Human Genome Research Institute at the NIH.

The NIH’s plan to require data-sharing hasn’t been entirely popular with the researchers themselves, at least not in the early stages. When it appeared last year, the initial version of the NIH's policy proposal drew criticism from the Federation of American Societies for Experimental Biology, the nation’s largest coalition of biomedical researchers, and the Association of American Medical Colleges, whose members include all 141 accredited U.S. medical schools.

Both organizations listed a series of possible problems, including a fear that the changes could mean increased administrative burdens for investigators and institutions. Both groups said on Wednesday through spokesmen that they had no immediate comment on the final version of the policy.

The NIH said the policy had roots in the Human Genome Project, in the 1990s, which raised hopes that a detailed examination of the genetic makeup of patients could prove powerful in treating and curing a variety of ailments.

The agency established a forerunner of the new policy in 2007, when it created a database for collecting test results and issued guidelines for the data’s use by researchers involved in "genome-wide association studies." Such studies involve searching the human genome for small variations that occur more frequently in people with a particular disease than in people without the disease.

'Benefit to Science'

That sharing effort has proved successful, several NIH officials declared in a report published on Wednesday in Nature Genetics. Over six years, more than 2,200 researchers in 41 countries have been given access to genomic data from 304 studies and produced more than 900 publications, they said.

The NIH recognizes the policy may put a greater burden on researchers, but considers the trade-off worthwhile, Dr. Green said. "If that means inconveniencing scientists along the way, but the overall benefit to science is greater, that has to win the day," he said.

The association of medical colleges, in its statement last year on the draft policy, suggested that it agreed with that overall point, even if it didn’t endorse some of the details. In fact, the association proposed that the NIH explicitly encourage further integration of such genomic data into a variety of medical-record formats.

The new NIH policy also encourages scientists to seek the broadest possible permissions from their human research participants to allow for future studies using their data. Information in the database is kept private, allowed only for research purposes, Dr. Green said. That includes protections against its use by private companies, such as insurers, or by law enforcement, NIH officials said.