NIH’s Policy for Data Management & Sharing
The NIH Policy for Data Management & Sharing became effective on January 25, 2023. The policy aims to promote the sharing of scientific data, accelerating biomedical research by enabling validation of research results, providing access to high-value datasets, and encouraging data reuse for future research studies. The DMSP must reflect the proposed approach to data management and sharing at the time it is prepared and must be updated throughout the life of the project, as appropriate. Moreover, the policy establishes that investigators are expected to share data to the maximum extent possible.
What studies does the new NIH policy for data management and sharing apply to?
Every NIH grant application that generates scientific data, regardless of the total direct costs per year, MUST include a data management and sharing plan (DMSP). Consequently, the new policy applies to all Research Projects, some Career Development Awards (Ks), Small Business SBIR/STTR, and Research Centers. When applicable, grant applications that require DMSP’s must include budget requests for data management. The new policy does not apply to Training (T), Fellowships (Fs), Construction (C06), Conference (R13), or Resource (Gs) grants, and Research-Related Infrastructure Programs (e.g., S06).
How does the NIH define Scientific Data in its new policy?
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
When is the DMSP submitted to NIH?
The DMSP and the data management budget are submitted with the grant application. Both will be reviewed by NIH Program Staff and study section reviewers. The approved DMSP will become a Term and Condition of the Notice of Award. Over the term of the award, the DMSP may be updated and re-approved as research progresses.
In addition, as of October 1, 2024, Research Performance Progress Reports (RPRR) must provide details on how investigators are adhering to their approved DMS Plans. Specifically, investigators must address five questions:
- Whether data has been generated to date and what type of data it is
- Whether data has been shared for use by others
- If data has been shared, in what repository and under what unique digital identifiers
- If data has NOT been shared, what is the status of data sharing (e.g. being prepared for submission, submitted to repository, not yet expected to be shared); and
- If data has not been generated and/or shared as outlined in an approved DMS plan, what corrective actions have been or will be taken to comply with the approved plan.
More information about RPRR requirements for DMS Plans may be found here:
What core elements and what format does NIH require for a DMSP?
In February 2026, the NIH announced that it had streamlined the core elements of a DMSP and created a DMSP form to aid compliance monitoring (NOT-OD-26-046). Effective May 25, 2026, DMSPs submitted with NIH applications should include only the following elements:
- Will there be maximum appropriate sharing of scientific data underlying peer-reviewed publications and other findings resulting from the work supported by this award (including preprints, refereed papers reported at conferences, and other findings)? [YES/NO]
- Will the scientific data underlying peer-reviewed publications be shared by the time of publication or, for other findings, by the end of the period of performance, which includes no-cost extensions? [YES/NO]
- Will shared scientific data be made available for at least as long as required by applicable data repository policies and/or journal policies? [YES/NO]
- If you answered “no” to elements 1, 2, or 3, or if you anticipate that sharing will be limited in some other way, please describe these limitations and the ethical, legal, or technical factors for them (see for example FAQ B.5 and other relevant FAQs). Your response should specify a particular reason(s) for limiting sharing. [300 words maximum]
- If scientific data derived from human research participants will be shared, will privacy, rights, and confidentiality of participants be protected as outlined in NOT-OD-22-213, including whether any scientific data will be shared using access controls? [YES/NO]
- In the table below, please list [100 words maximum]:
- Key types of scientific data anticipated to be generated during the project, including the species and modality, if known (e.g., “human genomic data,” “rat functional magnetic resonance imaging data”). NIH recognizes that not all data types expected to be generated in the study will meet the definition of scientific data or can be anticipated in advance. If a data type does not appear on the list, it does not imply that that data type will not be shared if it is generated in the study.
- The repository or an example of a repository where the scientific data may be managed and shared, if the scientific data is known at time of application. NIH expects the use of established repositories for preserving and sharing scientific data when they are available.
| Expected Data Type | Established Repository or Example |
- For studies subject to the NIH Genomic Data Sharing Policy (GDS) (e.g., using NIH funds to generate large-scale human genomic data):
- Will you share all large-scale human genomic and associated data in a NIH-designated repository according to the accelerated timelines expected in the GDS Policy?. If “no,” address in element 4. [YES/NO/Not Applicable]. If “no,” address in element 4.
- Do you anticipate that when sharing large-scale human genomic data that you will be able to meet the expectations of the Institutional Certification in the GDS Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-124.html; IV.C.5)? [YES/NO/Not Applicable] If “no,” address in element 4.
Are sample Data Management & Sharing Plans Available for Review?
NIH has provided sample DMS Plans as examples of how a DMS Plan could be completed in different contexts. Note that the sample DMS Plans provided below may reflect additional expectations established by NIH or specific NIH Institutes, Centers, or Offices that go beyond the DMS Policy. Applicants will need to ensure that their Plan reflects any additional, applicable expectations (including from NIH policies, ICO policies, or as stated in the FOA).
For Element 6: Oversight of Data Management and Sharing, ORED has prepared sample text:
At FIU, the PIs of proposals submitted to the NIH are required to develop, monitor, and manage Data Management and Sharing Plans (DMSP). FIU’s Office of Research and Economic Development (ORED) verifies that a DMSP is included in all new NIH proposals that generate scientific data. To ensure compliance with NIH DMSP guidelines, ORED requires each PI to certify at the time of RPRR and final report that the NIH-approved DMSP has been followed. Any changes to the DMSP must be reported to the NIH by the PI through ORED. ORED will periodically audit some NIH-approved DMSPs to monitor adherence.
PI First and Last Name, DEGREE, ORCID ID, will be responsible for the day-to-day oversight of the project team’s data management and data sharing activities, certifying adherence to the DMSP at the time of RPRR and final report, and contacting ORED to communicate any changes to the DMSP to the NIH.
| Sample | Description | NIH Institute or Center |
| Sample Plan A | Clinical and/or MRI data from human research participants | NIMH |
| Sample Plan B | Genomic data from human research participants | NIMH |
| Sample Plan C | Genomic data from a non-human source | NIMH |
| Sample Plan D | Secondary Data Analysis | NIMH |
Another excellent resource for information and sample DMSP’s is the National Institute of General Medical Sciences (NIGMS). Specific details regarding NIGMS’ expectations for its grantees and sample DMSP’s organized by research activity codes, including SBIR/STTR applications, and sample text for clinical trials may be found here.
How do researchers request funds for data management and sharing in their NIH grant applications?
Please refer to the website that NIH prepared entitled Budgeting for Data Management & Sharing.
Resources:
NIH has been working on this revised policy for more than three years. It has created a very informative website for Scientific Data Sharing and numerous additional resources of value to researchers. For more details about the new policy and DMSP’s, please refer to the following:
Announcement to University Community Re: DMSP Reporting Requirements for RPRRs
NIH Application Instruction Updates Data Management and Sharing (DMS) Costs (NOT-OD-23-161)
Overview of 2023 NIH Data Management & Sharing Policy
FAQs for 2023 Data Management & Sharing Policies and Procedures
Research Covered Under the new NIH Data Management & Sharing Policy
Writing a Data Management & Sharing Plan
NIH Data Management and Sharing Plan Format Page
Data Management and Sharing Plan Expectations for NIGMS Grantees
Budgeting for Data Management & Sharing
