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NIH Data Management and Sharing Policy

This guide supports researchers' efforts to comply with the NIH Data Management and Sharing Policy. It offers step-by-step guidance on how to plan for data sharing and write a data management and sharing plan to meet NIH requirements.

What to Include in Your Plan

NIH expects that researchers will maximize the appropriate sharing of scientific data. With this in mind, the "Access, Distribution, or Reuse Considerations" element of your data management and sharing plan should include descriptions and justifications for any limits on sharing. You should indicate here any limitations related to the following:

  • Informed consent (e.g., in cases where participant consent limits the scope or extent of sharing and future research use)
  • Privacy and confidentiality protections aligned with applicable federal, Tribal, and local laws, regulations, and policies (e.g., in situations with a greater risk of re-identification)
  • The controlled sharing of data derived from humans (i.e., requirements that such data be made available by a data repository only after approval)
  • Any restrictions imposed by federal, Tribal, or state laws, regulations, or policies
  • Any restrictions imposed by existing or anticipated agreements (e.g., with third-party funders, with partners, with repositories, with Health Insurance Portability and Accountability Act [HIPAA] covered entities that provide Protected Health Information under a data use agreement, or through licensing limitations attached to materials needed to conduct the research)
  • Any other considerations that may limit the extent of data sharing

For additional guidance, see NIH's FAQ, "What are justifiable reasons for limiting sharing of data?," and the NIH notice, "Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data."

For additional guidance related to sharing large-scale human genomic data, see "Elements to Include in a Data Management and Sharing Plan," section 5. Also, see the FAQs for NIH's Genomic Data Sharing Policy, particularly those related to "Submission of Human Genomic Data to Controlled-Access Databases" and "Consent for Broad Sharing."

What You Will See in the DMPTool

The DMPTool's section on the "Access, Distribution, or Reuse Considerations" element includes three text boxes, one for describing and justifying any limits on sharing, another for specifically addressing whether access to scientific data will be controlled, and a third for indicating, if applicable, how the privacy, rights, and confidentiality of human research participants will be protected.

Accompanying these boxes is sample language and considerable guidance from NIH, JHU, and the DMPTool.

See the "Planning Step 5: Consider Using the DMPTool to Write Your DMS Plan" page of this guide for more about the DMPTool.

The DMPTool's section on access/distribution/reuse