NIH’s New Policy for Data Management & Sharing
Effective January 25, 2023
The new NIH Policy for Data Management & Sharing becomes 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. 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.
What are the core requirements for a DMSP?
In a maximum of two pages, each DMSP must outline how data will be managed and shared by addressing each of the following elements:
- Data type
- Related tools, software, and/or code
- Standards, data preservation, access
- Associated timelines, access, distribution, or reuse considerations
- Oversight of data management and sharing
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:
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
Data Management and Sharing Plan Expectations for NIGMS Grantees
Budgeting for Data Management & Sharing
