Research Covered Under the Data Management & Sharing Policy

Research Covered by 2003 NIH Data Sharing Policy

NIH’s 2003 Data Sharing Policy applies to research that fulfills all of the following conditions:

• The research is supported by NIH through grants, cooperative agreements, intramural research, contracts, or other funding agreements. 
• The applicant sought $500,000 or more in direct costs in any year of the proposed project periods.
• The application was submitted on or after October 1, 2003, but before January 25, 2023.

NIH’s 2003 Data Sharing Policy applies to the sharing of final research data. Note that if an applicant seeks NIH support to transform or link datasets (as opposed to generating a new set of data), NIH’s 2003 Data Sharing Policy still applies.

Final research data is recorded factual material commonly accepted in the scientific community as necessary to document and support research findings. For many scientific areas, final research data includes both raw data and analyses conducted on the data.

For example, final research data for a clinical study would include a dataset that was used in the published study, but not the clinical documents (for example, medical records) that the dataset was derived from.

Generating large-scale genomic data? NIH’s Genomic Data Sharing (GDS) policy may also apply to your research. Note that on or after January 25, 2023,  projects subject to the GDS Policy should describe their plans for sharing genomic data as expected by the GDS Policy as part of their DMS Plan.

• To learn if a project falls under the GDS Policy, see Does GDS Apply to My Research?
• To understand how to develop a DMS Plan that complies with the GDS Policy, see Writing a Data Management and Sharing Plan.
   

Foreign Collaborations

Policies related to data sharing vary across countries. Investigators from foreign institutions and U.S. investigators collecting data in other countries should familiarize themselves with the policies governing data sharing in the countries in which they plan to work and address any specific limitations in the data sharing plan in their application. For more information, view this presentation on planning for foreign collaborations.

Proprietary Data

NIH understands that some scientific data generated with NIH funds may be proprietary. In particular, under the Small Business Act, Small Business Innovation Research (SBIR) grantees may withhold their data for 20 years after award date, unless NIH obtains permission otherwise. However, NIH still expects SBIR applicants to address data sharing in their applications.

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 there may be circumstances where a co-funder has requested restrictions on data sharing as a condition of funding. The application should identify these restrictions and propose how data from the co-funded project will be shared. NIH staff will evaluate the justifications of investigators who believe that they are unable to share data.

For questions or concerns about data sharing expectations for proprietary data, please contact the Office of Science Policy. Small businesses may wish to contact the NIH SEED Office.

Research Covered by the 2023 Data Management & Sharing Policy

The NIH Data Management & Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data.

This includes all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements.

For more about expectations of the policy, see the Data Management and Sharing Policy Overview page.

Scientific Data is defined as data commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications.

• Scientific data includes any data needed to validate and replicate research findings.
• Scientific data does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens.

The DMS Policy applies to all research that generates scientific data, including but not limited to:

• Research Projects
• Some Career Development Awards (Ks)
• Small Business SBIR/STTR 
• Research Centers

 The DMS Policy does not apply to research and other activities that do not generate scientific data, including but not limited to:

• Training (T)
• Fellowships (Fs)
• Construction (C06)
• Conference Grants (R13)
• Resource (Gs)

Be sure to check out our complete list of NIH activity codes subject to the DMS Policy as well as your funding opportunity to determine if the DMS Policy applies to your application.

You may be subject to additional sharing policies. To find out more, check our list of NIH Institute and Center Data Sharing Policies and/or use the decision tool Which Policies Apply to My Research?

Policy Effective Date

The effective date for the DMS Policy is January 25, 2023. Specifically, the policy applies to:

• Competing grant applications that are submitted to NIH for January 25, 2023 and subsequent receipt dates.
• Proposals for contracts that are submitted to NIH on or after January 25, 2023.
• NIH Intramural Research Projects conducted on or after January 25, 2023.
• Other funding agreements (e.g., Other Transactions) that are executed on or after January 25, 2023, unless otherwise stipulated by NIH.

Foreign Collaboration

Policies related to data sharing vary across countries. Investigators from foreign institutions and U.S. investigators collecting data in other countries should familiarize themselves with the policies governing data sharing in the countries in which they plan to work and to address any specific limitations in the plan in their application. For more information, view this presentation on planning foreign collaborations.

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.

For questions or concerns about data sharing expectations for proprietary data, please contact the Office of Science Policy. Small businesses may wish to contact the NIH SEED Office.