NIH Data Management and Sharing Plan Guidance
Overview
Introduction
NIH issued the Data Management and Sharing (DMS) policy (effective January 25, 2023) to promote the sharing of scientific data. Read more at sharing.nih.gov, but in short, under the DMS policy, NIH expects that investigators and institutions:
- Plan and budget for the managing and sharing of data
- Submit a DMS plan for review when applying for funding
- Comply with the approved DMS plan
The Health Sciences Library provides a free service to assist with DMS Plan creation and implementation.
- Complete the request form for a librarian review of your NIH DMS plan
Data Management and Sharing Consultation Services
Are you an investigator facing a grant application or renewal and need a data management and sharing plan (DMSP) reviewed? UVA Health offers both free and fee-based assistance to:
- Discuss your plan in the context of your funder and/or FOA requirements
- Consult on your draft plan or route to other UVA DMSP services
- Review and providing feedback on your plan prior to submission or after Program Officer comments. Areas of focus include:
- Identifying an appropriate repository
- Referring to documentation and metadata standards
- Incorporating UVA-approved language for oversight
UVA Health Services
- Learn more about services to assist UVA Health investigators with data management related to public access compliance on our guide.
- Jump straight to requesting assistance with your DMS plan through this request form.
Plan Elements
Developing Your Plan
For a good overview of what data management and sharing entails, see Sharing Data: The Basics from NCI/NIH.
Below are the six required elements to be addressed in the Data Management and Sharing Plan. This page summarizes information from the NIH data sharing website's Elements page and the Format page.
Consult the table below for required elements (left) and local guidance (right), including links to UVA resources and experts.
Writing tip: do not include hypertext (e.g., hyperlinks and URLs) in the DMS Plan attachment. The hyperlink policy applies to DMS Plans as well, and NIH may withdraw your application from consideration if you include them.
ELEMENT 1: DATA TYPE |
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| NIH Description | UVA Guidance |
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Briefly describe the scientific data to be managed and shared A. Types and Amount Summarize the types and amount of scientific data to be generated and/or used in the research. Describe your data in general terms (e.g., 256-channel EEG data and fMRI images from ~50 research participants). Descriptions may indicate the data modality (e.g., imaging, genomic, mobile, survey), level of aggregation (e.g., individual, aggregated, summarized), and/or the degree of data processing that has occurred (i.e., how raw or processed the data will be) |
Consider phrasing as below, replacing the bracketed information with your specifics. Example:
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B. Preservation and Sharing Describe which scientific data from the project will be preserved and shared and provide the rationale for this decision.
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Preservation: Briefly describe which data will be preserved, referencing any applicable funder or institutional requirements for preservation/records retention UVA specifics: see UVA RES-002: Ownership, Retention, Safeguarding, Management, and Transfer of Research Records and the UVA Research Records site. Sharing: Briefly describe which data will shared and your reasoning |
C. Metadata and Documentation Briefly list the metadata, other relevant data, and associated documentation (e.g. study protocols, and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data |
Note what documentation will accompany the shared data to aid reuse, e.g. readme files, data dictionaries, metadata, survey instruments. |
ELEMENT 2: RELATED TOOLS, SOFTWARE AND/OR CODE |
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| NIH Description | UVA Guidance |
| Indicate whether specialized tools are needed to access or manipulate shared scientific data to support replication or reuse, and name(s) of the needed tool(s) and software |
Describe whether specific software programs or tools are required to open or re-analyze shared datasets. Consider important attributes such as the software version and any needed packages or extensions, and where they can be found. It is not necessary here to document what software/tools were used to generate the data (this could be included in your documentation). Examples:
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ELEMENT 3: STANDARDS |
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| NIH Description | UVA Guidance |
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Describe what standards, if any, will be applied to the scientific data and associated metadata State what common data standards will be applied to the scientific data and associated metadata to enable interoperability of datasets and resources, and provide the name(s) of the data standards that will be applied and describe how these data standards will be applied to the scientific data generated by the research proposed in this project. If applicable, indicate that no consensus standards exist. |
List which common data standards exist for your scientific data considering standards for terminology, content, and/or data exchange (e.g. ICD-10, CDISC, MINSEQE, DICOM, etc.). Decide which ones you will employ, thinking about what standards would help someone understand the data you collect and potentially combine it with other related datasets. If the repository you have chosen requires specific standards, list those here. If there are no consensus data standards for your research area, state that here. |
ELEMENT 4: DATA PRESERVATION, ACCESS, AND ASSOCIATED TIMELINES |
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| NIH Description | UVA Guidance |
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Give plans and timelines for data preservation and access A. Repository Provide the name of the repository(ies) where scientific data and metadata arising from the project will be archived B. Findability Describe how the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools. C. When and How Long Describe when the scientific data will be made available to other users (i.e., no later than time of an associated publication or end of the performance period, whichever comes first) and for how long data will be available.
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If you are sharing data: Indicate what repository you have chosen to share your data, considering NIH's desired characteristics. NIH states that primary consideration should be given to data repositories that are discipline or data-type specific. If none are available, consider generalist repositories or UVA 's institutional repository LibraData. For Findability, note if the repository assigns persistent identifiers such as a DOI or accession number. For When, most plans should reference NIH's language "no later than time of an associated publication or end of the performance period, whichever comes first". For How Long you can reference the retention policy of the repositories. If you are not sharing data: Describe how, and for how long, your data will be preserved. How long to maintain data Note that under Section 8.4.2 of the NIH Grants Policy Statement, grantee institutions are required to keep the data for 3 years following closeout of a grant or contract agreement. Contracts may specify different time periods. UVA retention rules are described in UVA RES-002: Ownership, Retention, Safeguarding, Management, and Transfer of Research Records. |
ELEMENT 5: ACCESS, DISTRIBUTION, OR REUSE CONSIDERATIONS |
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| NIH Description | UVA Guidance |
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Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data related to any considerations that may limit the extent of data sharing A. Factors NIH expects that in drafting Plans, researchers maximize the appropriate sharing of scientific data. Describe and justify any applicable factors or data use limitations affecting subsequent access, distribution, or reuse of scientific data related to informed consent, privacy and confidentiality protections, and any other considerations that may limit the extent of data sharing. See Frequently Asked Questions for discussion of justifiable reasons for limiting sharing of data. B. Access Control State whether access to the scientific data will be controlled (i.e., made available by a data repository only after approval). C. Protections If generating scientific data derived from humans, describe how the privacy, rights, and confidentiality of human research participants will be protected (e.g., through de-identification, Certificates of Confidentiality, and other protective measures). |
Limiting Factors for data sharing may include institutional policies, patent and intellectual property rules, data size limitations, informed consent that doesn't allow for sharing (HIPAA), revised Common rule, federal, state, local rules, and tribal rules. Genomic data rules also should be considered. For Access Control, describe any controlled access practices (e.g. via a Data Sharing Agreement); if using a repository, reference its options for limiting access (note that Vivli, dbGAP, NIMH's Data Archive (NDA) and many others offer controlled access options). Refer to any Protections utililized such as de-identification methods. Learn more about how to address access to data from Human Subjects research in your Data Management and Sharing Plan. |
ELEMENT 6: OVERSIGHT OF DATA MANAGEMENT AND SHARING |
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| NIH Description | UVA Guidance |
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Indicate how compliance with the DMS plan will be monitored and managed Describe how compliance with this Plan will be monitored and managed, frequency of oversight, and by whom at your institution (e.g., titles, roles). |
Describe oversight and reporting responsibilities, e.g. updating and revising the DMS Plan if necessary. View UVA sample language on Oversight/Compliance for your plan. Consider describing data management responsibilities, e.g., data capture, documentation, quality review, storage and backup, and who will be responsible, e.g. positions and roles; data preservation and/or sharing responsibilties, e.g. data deposit (and utilization of any access controls if needed) and name those responsible (as above). |
Background Information
What's New?
NIH has issued a final Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This Policy requires submission of a Data Management and Sharing Plan (DMSP) for grant applications for NIH-supported research that results in the generation of scientific data.
Investigators are required to:
- Submit a DMSP (approximately two pages) outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.
- The Plan may request funds toward data management and sharing in the budget and budget justification sections of the application.
- Comply with the DMSP approved by the funding Institute or Center (IC).
When?
NIH applications for receipt dates on or after January 25 2023 require submission of a DMSP, including new proposals or active NIH awards going up for renewal with receipt date of January 2023.
Who?
The 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: Research Projects, some Career Development Awards (Ks), Small Business SBIR/STTR, and Research Centers.The DMS Policy does not apply to research and other activities that do not generate scientific data, including: Training (T), Fellowships (Fs), Construction (C06), Conference Grants (R13), Resource (Gs), Research-Related Infrastructure Programs (e.g., S06).
- NIH Institute and Center Data Sharing Policies - check if your IC has specific data sharing policies in addition to the trans-NIH policies.
- Applicable Activity Codes: comprehensive listing of all NIH activity codes that generally require applicants to submit a DMSP
Why?
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.
How do I get started?
Review the core information from NIH below to familiarize yourself with the DMS Policy and Plan. Then, visit the Plan Elements for guidance in preparing your plan.
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What Should I Know? NIH's new Scientific Data Sharing website contains the latest information from NIH. It includes:
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Selected NIH Policies
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Selected NIH Policies NOT-OD-21-013 - Final NIH Policy for Data Management and Sharing (October 29, 2020) NOT-OD-22-189 - Implementation Details for the NIH Data Management and Sharing Policy (August 5, 2022) NOT-OD-21-013 - Supplemental Information to the NIH Policy for Data Management and Sharing: Protecting Privacy When Sharing Human Research Participant Data (September 21, 2022) NOT-OD-21-014 - Supplemental Information to the NIH Policy for Data Management and Sharing: Responsible Management and Sharing of American Indian/Alaska Native Participant Data (September 21, 2022) |
Learn More
Learning Opportunities
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Webinars and Training UVA Webinar: NIH’s New Data Management and Sharing Policy (12/15/22) Additional learning opportunities, including informational webinars and accompanying slide decks |