NIH research proposals that generate data are required to comply with the policy beginning January 25th 2023.
Effective January 25, 2023, the Data Management & Sharing (DMS) Policy 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.
- Scientific data include: the recorded factual material 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 do not include: Data not of sufficient quality to validate or replicate findings OR laboratory notebooks, preliminary analysis, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects.
Under the DMS Policy, NIH requires researchers to prospectively plan for how scientific data will be preserved and shared through submission of a Data Management and Sharing Plan (DMSP). For applicable grant and contract proposals, investigators are required to:
- Submit a DMSP as part of the funding application or proposal outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.
- Comply with the DMSP approved by the NIH funding Institute or Center (IC).
The DMS Policy does not apply to research and other activities that do not generate scientific data, for example: training, infrastructure development, and non-research activities. Please note that some K awards will be subject to the policy if the award includes funding for research that generates scientific data. For more information about the grants and activity codes covered or exempt by the 2023 Data Management and Sharing Policy, review the References below.
References: Data Management and Sharing Policy Overview, Research Covered by the 2023 Data Management and Sharing Policy.
NIH proposals that generate data are required to include a DMSP with an emphasis on data sharing and preservation.
Sharing scientific data accelerates biomedical research discovery, enhances research rigor and reproducibility, provides accessibility to high-value datasets, and promotes data reuse for future research studies. Ultimately, the sharing of scientific data expedites the translation of research results into knowledge, products, and procedures to improve human health.
As outlined in NIH's Supplemental Policy Information “Selecting a Repository for Data Resulting from NIH-Supported Research,” using a quality data repository generally improves the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data. For that reason, NIH strongly encourages the use of established repositories (See “Data Sharing and Preservation” below) to the extent possible for preserving and sharing scientific data.
NIH expects that researchers will take steps to maximize scientific data sharing, but may acknowledge in DMSPs that certain factors (e.g., ethical, legal, technical) may necessitate limiting sharing to some extent. Foreseeable limitations should be described in DMSPs. Per the Supplemental Policy Information “Elements of an NIH Data Management and Sharing Plan,” a compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH.
NIH respects and recognizes Tribal sovereignty and American Indian and Alaska Native (AI/AN) communities’ data sharing concerns, and NIH has proposed additional considerations when working with Tribes in the draft Supplemental Policy Information “Responsible Management and Sharing of AI/AN Participant Data.”
References: Data Management and Sharing Policy Overview, NIH Policy Frequently Asked Questions, Selecting a Data Repository
DMSPs are reviewed by NIH staff. Peer reviewers can comment on the budget, but not on the plans.
Peer reviewers may comment on the proposed budget for data management and sharing, although these comments will not impact the overall score, unless sharing data is integral to the project design and specified in the Funding Opportunity Announcement. This approach balances the benefit of consistency afforded by NIH program staff review of plans, review of updates, and compliance monitoring, with the opportunity for peer reviewers to comment on the requests for data management and sharing costs. Over time, and through these reviews, the NIH is hoping to learn more about what constitutes reasonable costs for various data management and sharing activities across the NIH portfolio of research.
For contracts, the evaluation of DMSPs will be conducted by the agency, with input from the Contracting Officer’s Representative (COR) and other NIH subject-matter experts as part of the proposal evaluation process.
References: NIH Frequently Asked Questions, Writing a Data Management & Sharing Plan
Data should be shared no later than the time of publication or end of the award, whichever comes first.
Scientific data should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the period of performance, whichever comes first. The DMS Policy expects scientific data to be shared at the earlier of:
- The time of an associated publication: Scientific data underlying peer-reviewed journal articles should be made accessible no later than the date on which the peer-reviewed article is first made available in print or electronic format.
OR
- The end of the performance period: Scientific data underlying findings not disseminated through peer-reviewed journal articles should be shared as soon as possible and no later than the end of the performance period. These scientific data may underlie unpublished key findings, developments, and conclusions; or findings documented within preprints, conference proceedings, or book chapters. For example, scientific data underlying null and negative findings are important to share even though these key findings are not always published. Researchers should be aware that some preprint servers may require the sharing of data upon preprint posting, and repositories storing data may similarly require public release of data upon preprint posting.
NIH Institutes, Centers and Offices (ICOs), funding opportunity announcements (FOAs), and other NIH policies (e.g., the Genomic Data Sharing Policy) may specify earlier expectations for data sharing timelines, in which case, the data should be made available as required by those expectations. To ensure compliance with the DMSP, Contracting Officers (COs) shall include the timeframe for data sharing in all applicable contract deliverables.
If a no-cost extension is granted for an extramural award, scientific data should be made accessible no later than the time of an associated publication, or the end of the no-cost extension, whichever comes first.
References: NIH DMSP Frequently Asked Questions
Compliance is expected and monitored at regular intervals.
The DMS Policy states, “after the end of the funding period, non-compliance with the NIH ICO-approved Plan may be taken into account by NIH for future funding decisions for the recipient institution.”
NIH will monitor compliance with DMSPs over the course of the funding period during regular reporting intervals (i.e., at the time of annual Research Performance Progress Reports (RPPRs)). Noncompliance with DMSPs may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award. If award recipients are not compliant with DMSPs at the end of the award, noncompliance may be factored into future funding decisions.
For contracts, noncompliance with the DMSP will be handled in accordance with the terms and conditions of the contract and applicable Federal Acquisition Regulation (FAR).
References: NIH DMSP Frequently Asked Questions
