January 9, 2020: NIH Collaboratory Investigators Respond to Draft NIH Policy on Data Sharing

NIH Collaboratory leadership and Demonstration Project principal investigators, along with their colleagues, responded this week to the recently released Draft NIH Policy for Data Management and Sharing and supplemental draft guidance. The draft policy proposes that applicants for research funding submit a plan describing how scientific data will be managed and shared.

“We applaud the NIH’s policy and commitment to making the results and outputs of the research it funds and conducts available to the public. We enthusiastically support data sharing and agree with the principles of this policy. However, we believe more detail is warranted about the different types of research (ie, embedded pragmatic research), the associated protections, and acceptable mechanisms for sharing data, such as public and private archives and enclaves.” —Response to Draft NIH Policy for Data Management and Sharing

The main topics covered in the response are:

  • Support for the goals of the draft data sharing policy
  • Assessing and mitigating re-identification risk
  • Protecting secondary subjects
  • Use of data enclaves
  • Crediting those who share data

Other signatories include participants in the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative of the Leadership Consortium for Value and Science-Driven Health Care, and leaders of the Health Care Systems Research Network.

The full letter is available for download and includes the list of signatories.

Comments are due no later than January 10, 2020, and may be submitted online.

For more on data sharing, see the Living Textbook chapter, Data Sharing and Embedded Research.