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Today, nearly twenty years after the publication of the Final NIH Statement on Sharing Research Data in 2003, we have released a Final NIH Policy for Data Management and Sharing. This represents the agency’s continued commitment to share and make broadly available the results of publicly funded biomedical research. We hope it will be a critical step in moving towards a culture change, in which data management and sharing is seen as integral to the conduct of research. Responsible data management and sharing is good for science; it maximizes availability of data to the best and brightest minds, underlies reproducibility, honors the participation of human participants by ensuring their data is both protected and fully utilized, and provides an element of transparency to ensure public trust and accountability.

This policy has been years in the making and has benefited enormously from feedback and input from stakeholders throughout the process. We are grateful to all those who took the time to comment on Request for Information, the Draft policy, or to participate in workshops or Tribal consultations. That thoughtful feedback has helped shape the Final policy, which we believe strikes a balance between reasonable expectations for data sharing and flexibility to allow for a diversity of data types and circumstances. How we incorporated public comments and decision points that led to the Final policy are detailed in the Preamble to the DMS policy.

The Final policy applies to all research funded or conducted by NIH that results in the generation of scientific data. The Final Policy has two main requirements (1) the submission of a Data Management and Sharing Plan (Plan); and (2) compliance with the approved Plan. We are asking for Plans at the time of submission of the application, because we believe planning and budgeting for data management and sharing needs to occur hand in hand with planning the research itself. NIH recognizes that science evolves throughout the research process, which is why we have built in the ability to update DMS Plans, but at the end of the day, we are expecting investigators and institutions to be accountable to the Plans they have laid out for themselves.

I strongly suspect we will hear both from those who think we should have gone farther and required that all data resulting from NIH-funded research be shared, regardless of extenuating factors, and those who think we have gone too far in requiring all applicants to develop a Plan. Which perhaps means we’ve gotten it just right! For some investigators and disciplines, who have been at the forefront of data sharing, this will be very familiar; for others, this will be new territory. Anticipating that variation in readiness, and in recognition of the cultural change we are trying to seed, there is a two-year implementation period. This time will be spent developing the information, support, and tools that the biomedical enterprise will need to comply with this new policy. NIH has already provided additional supplementary information – on (1) elements of a data management and sharing plan; (2) allowable costs; and (3) selecting a data repository – in concert with the policy release.

As NIH Director Francis Collins notes in his Director’s Statement today, the novel coronavirus pandemic has highlighted the importance of making research data broadly accessible. But even as the world struggles with this acute global crisis, it is important to note that we are at an extraordinary time in biomedical science, where new technologies, data science, and understanding of fundamental biology are converging to accelerate the pace of discovery and medical advancement. The Final NIH Policy for Data Management and Sharing builds on those exciting opportunities, and we look forward to working with our stakeholders to fulfill its vision.

Posted by Dr. Carrie D. Wolinetz, October 29, 2020