The National Institutes of Health will require applicants for federal research funding to submit a plan outlining how data gleaned from a potential project will be shared with the public, Director Francis Collins told CQ Roll Call. This move is part of a larger push from President Barack Obama’s administration to make information gathered from government-backed studies more public.
Academic research institutions and others have traditionally kept such data private. One of the more commonly cited justifications is the need to keep information proprietary in order to enhance their future applications with unique data and earn additional grants from the NIH. Collins said in an interview that notion is no longer accurate, and said the agency will begin to require applicants to all NIH centers to include a data-sharing strategy in grant proposals.
“We are going to expect that applicants who are generating data sets to produce a data-sharing plan or we are not going to fund them. And for applicants who basically have failed to live up to their responsibilities for data sharing, that will hurt them in their next opportunity to get funds from NIH. So any idea that hanging on to your data is going to help you in a future application to this institution is wrong-headed,” he said in a recent interview.
The NIH earlier this year finalized a rule that requires entities that conduct NIH-funded research to report the results on ClinicalTrials.gov, a federal database of clinical research. Collins could not say when that policy would be implemented across the agency, but said the NIH is in the “middle of figuring out how to regularize that” across the different NIH centers.
Heather Pierce, senior director of science policy and regulatory counsel at the Association of American Medical Colleges, said the move by NIH represents a broader shift for biomedical research as a whole.
“The conversation has moved from the theoretical to real policy changes at different levels,” Pierce told CQ Roll Call. “There are lots of efforts in this area, but it is generally a pretty heavy lift to have universal data sharing.”
Pierce would not say to what extent the group’s member institutions currently submit data-sharing plans as a part of the grant application process, and said AAMC was working with its members on “a number of different efforts related to helping think through the implementation of data sharing.”
Congressional advocates of the NIH’s efforts praised the agency’s move to require a strategy on data sharing as a contingent for federal research support.
“Dr. Collins is right to raise the bar on expectations for data-sharing on federally-funded research,” Sen. Elizabeth Warren, D-Mass., said in an emailed statement. “Improving data transparency is a key step to ensuring the integrity of our clinical trial system, and we need to move toward a baseline expectation that data from clinical trial research will be shared.”
Collins, who took the helm at NIH in 2009 after leading the National Human Genome Research Institute within the agency, is highly regarded by both the research community and congressional leaders.
He declined to say whether he would be interested in serving as director in the next administration, only noting that it would “depend a lot on the circumstances.” Many within industries and organizations that work with the NIH, however, hope he remains in charge.
Vice President Joseph R. Biden Jr. has championed the open sharing of data as a main tenet of the cancer “moonshot” initiative. In almost all of his public speeches on the program, Biden has not minced words in criticizing the tendency within the research community to keep data proprietary and outside of the public realm.
A 2015 study found that institutions across the board had relatively low reporting numbers, but that the pharmaceutical industry was better at uploading results from studies after one year than was academia.