Skip to Main Content
It looks like you're using Internet Explorer 11 or older. This website works best with modern browsers such as the latest versions of Chrome, Firefox, Safari, and Edge. If you continue with this browser, you may see unexpected results.

NIH Data Management and Sharing Policy

Guide to Complying With the 2023 NIH Data Management and Sharing Policy

Considerations for Human Subjects Data

While the NIH expects that researchers will attempt to maximize scientific data sharing in their DMS Plans,  they acknowledge that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Investigators are required to still follow federal regulations for the protection of human research participants, other NIH expectations for the use and sharing of scientific data derived from human participants as well as any other applicable laws, regulations, statutes, guidance or institutional policies related to research with human participants and the protection of participant privacy. 

For research on human subjects, The NIH encourages award recipients to:

  • Address data management and sharing issues during the informed consent process to ensure prospective participants understand how their data will be managed and shared
  • Outline steps they will take for protecting the privacy, rights, and confidentiality of prospective participants (i.e., through de-identification, Certificates of Confidentiality and other protective measures)
  • Assess limitations on subsequent use of data and communicate these limitations to the individuals or entities (e.g., repositories) preserving and sharing data
  • Consider whether access to shared scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. Sharing through controlled access may be specific by certain funding opportunity announcements of the funding NIH Institutes or Centers. 

Informed Consent and Data Sharing

Although the DMS policy strongly encouragers researchers to plan for how data management and sharing will be addressed in the informed consent process and to maximize the appropriate sharing of scientific data when developed DMS Plans, the policy does not expect that informed consent given by participants will be obtained in any particular way, such as through consent for broad data sharing (e.g., the broad consent provision of the Common Rule). Investigators, however, should be aware that they may be subject to other requirements or particular expectations for consent, such as the NIH Genomic Data Sharing Policy. 

Considerations for Proprietary Data

Some scientific data generated with NIH funds may be proprietary. The NIH has provided guidance on proprietary data for the following groups: 

SBIR and STTR Awardees

Some data generated with NIH funds may be proprietary. Under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive (effective May 2019), SBIR and STTR awardees may without applicable data for 20 years after the award date, as stipulated in the specific SBIR/STTR funding agreement and consistent with achieving program goals. SBIR and STTR awardees are still expected to submit a DMS Plan per new policy requirements. 

Investigators co-funded by the private sector

For research co-funded by the private sector (for example, the pharmaceutical or biotechnology industries), the extent of data sharing may be limited by restrictions imposed by licensing limitations attached to materials needed to conduct research. The NIH suggests that applicants should discuss projects with proposed collaborators early to avoid agreements that prohibit or unnecessarily restrict data sharing. NIH staff will evaluate the justifications of investigators who believe that they are unable to share data.