The U.S. National Institutes of Health last week released a draft policy that will require all investigators with NIH funding to make their data sets available to colleagues. For the first time, grantees holding any NIH-funded grant—not just those above a $500,000 threshold in direct costs—will need to submit a detailed plan for sharing data, including steps to protect the privacy of research subjects.

For the biomedical research community, the draft rules, which update a 2003 policy, aren’t a big surprise: NIH has been gathering input on its ideas for the past 3 years. “We knew there was a lot of anxiety in the community about this and so we slowly shared our thinking and its evolution,” says Carrie Wolinetz, associate director for science policy at NIH in Bethesda, Maryland. Now, she says, “This is what the policy looks like in draft form.”

NIH will collect comments through 10 January 2020 and hopes to finalize the new rules next year. Here is more background on the policy:

NIH and its 27 institutes already have many data sharing policies, for example for genomic data and clinical trial results. Certain programs require data sharing, such as the Cancer Moonshot. And journals often have similar requirements. Why is a new NIH-wide policy needed?

Because many researchers still aren’t sharing their data, Wolinetz says. At one extreme, genomics researchers have a long tradition of sharing data sets; on the other hand, in epidemiology, “There is a more protective culture of holding on to data.” Sharing among basic researchers also varies by field, she says.

How are the new draft rules different from the 2003 policy?

NIH is now asking for more details on how the investigator plans to manage and share their data, Wolinetz says. “This is a little bit weightier than the previous plan” and applies to all NIH-funded research, not just large programs.

NIH isn’t asking that data be released within a certain time frame; it just says they “should be made available as soon as practicable.” Why not specify a timeline?

Because different disciplines will have different standards. “We are giving a lot of leeway. It’s impossible to come up with a one-size-fits-all policy,” Wolinetz says. But if a proposal is “out of the norm” for the researcher’s field or funding institute, “that’s going to be taken into account,” she adds.

Who will check the data sharing plan, and at what stage of the project? And what if a researcher doesn’t comply?

It will not be part of peer review, but program staff will assess the plan for a project awaiting an award and later “hold you accountable,” Wolinetz says. If an investigator does not follow through and share their data, they “may not receive additional funding.” Although revoking a grant for failing to share data is “a theoretical possibility,” in reality NIH usually resolves such issues through “conversations with institutions and investigators,” she adds.

NIH has been funding some data repositories, such as Figshare and the STRIDES cloud initiative. Does the agency ultimately want data sets to be deposited in NIH-sponsored repositories?

No decisions have been made. The best sustainable model for storing data long term “is very much a question on the table right now. These pilots represent our attempt to answer some of those questions,” Wolinetz says.