Skip to Main Content

NIH Scientific Data Sharing Policy: Limitations on Sharing

This guide explains the requirements related to scientific data sharing for NIH-funded research.

What are justifiable reasons for limiting sharing of data?

From the NIH data sharing FAQs page:

 Potential examples of justifiable factors include:

  • informed consent will not permit or will limit the scope or extent of sharing and future research use
  • existing consent (e.g., for previously collected biospecimens) prohibits sharing or limits the scope or extent of sharing and future research use
  • privacy or safety of research participants would be compromised or place them at greater risk of re-identification or suffering harm, and protective measures such as de-identification and Certificates of Confidentiality would be insufficient
  • explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure
  • 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, through licensing limitations attached to materials needed to conduct the research)
  • datasets cannot practically be digitized with reasonable efforts

Examples of reasons that would generally not be justifiable factors limiting scientific data sharing include:

  • data are considered to be too small
  • data that researchers anticipate will not be widely used
  • data are not thought to have a suitable repository

Proprietary Data

From Research Covered Under the Data Management & Sharing Policy:

Considerations for Proprietary Data

NIH understands that some scientific 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 2, 2019, SBIR and STTR awardees may withhold 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 expected to submit a Data Management & Sharing Plan per DMS Policy requirements.

Issues related to proprietary data also can arise when co-funding is provided by the private sector (for example, the pharmaceutical or biotechnology industries). NIH recognizes that the extent of data sharing may be limited by restrictions imposed by licensing limitations attached to materials needed to conduct the research. 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.