NIH Data Management and Sharing Policy (DMSP)
NIH Data Management and Sharing Policy (DMSP)
New NIH Funding Requirement Starting January 25
Beginning in January 2023, Final NIH Policy for Data Management and Sharing (NOT-OD-21-013) will require researchers to include a data management and sharing (DMS) plan in funding applications. In preparation for the policy implementation, NIH has launched a Scientific Data Sharing Website.
The Final DMS Policy applies to all research, funded in whole or in part by NIH, that results in the generation of scientific data. This includes competing grant applications and proposals for contracts that are submitted to NIH on or after the January 25, 2023, submission deadline. The DMS Policy does not apply to research and other activities that do not generate scientific data, including training, infrastructure development, and non-research activities.
Once a grant has been awarded, the DMS Plan becomes part of the award's terms and conditions. NIH expects researchers and institutions to implement data management and sharing practices as described in their approved Plan. Compliance with the DMS Plan, including any updates, may be reviewed during regular reporting intervals.
The DMS Policy applies to all research that generates scientific data, including Research Projects, some Career Development Awards, SBIR/STTR, and Research Centers. The DMS Policy does not apply to research and other activities not generating scientific data, including Training Grants, Fellowships, Construction (C06), Conference Grants, Resource (Gs), and Research-Related Infrastructure Programs.
Explore these NIH Introductory Webinars outlining the new requirements.
Researchers will be required to submit a DMS plan at the time of application to the funding NIH Institute, Center, or Office (ICO) that outlines how scientific data and related metadata will be managed and shared, including any potential restrictions or limitations.
Below are the six required elements and some details on how to address them. NIH has published a Data Management and Sharing Plan Elements Guide which you can read for more information.
Element 1: Data Type
Summarize the types and estimated amount of scientific data expected to be generated in the project. Describe which scientific data from the project will be preserved and shared. NIH does not anticipate that researchers will preserve and share all scientific data generated in a study. Researchers should decide which scientific data to preserve and share based on ethical, legal, and technical factors. The plan should provide the reasoning for these decisions. Briefly list the metadata, other relevant data, and any associated documentation (e.g., study protocols and data collection instruments) that will be made accessible to facilitate interpretation of the scientific data.
Element 2: Related Tools, software, and code
State whether specialized tools, software, and/or code are needed to access or manipulate shared scientific data, and if so, provide the name(s) of the needed tool(s) and software and specify how they can be accessed.
Element 3: Standards
State what common data standards, if any, 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.
Element 4: Data Preservation, Access, and Associated Timelines
Provide the name of the repository(ies) where scientific data and metadata arising from the project will be archived. Describe how the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools. 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.
Element 5: Factors affecting access, distribution, or reuse of scientific data, controlled access and privacy considerations
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. State whether access to the scientific data will be controlled (i.e., made available by a data repository only after approval). 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).
Element 6: Oversight of Data Management and Sharing
Describe how compliance with this Plan will be monitored and managed, frequency of oversight, and by whom at your institution (e.g., titles, roles). This element refers to oversight by the funded institution, rather than by NIH. The DMS Policy does not create any expectations about who will be responsible for Plan oversight at the institution. At UCCS, the PI and their team are responsible for oversight and compliance with their DMSP.
In addition, researchers proposing to generate scientific data derived from human participants will need to describe how privacy, rights, and confidentiality of human research participants will be protected.
This article Ten simple rules for maximizing the recommendations of the NIH data management and sharing plan by Sara Gonzales Matthew B. Carson, and Kristi Holmes provides 10 key recommendations for creating a DMSP that is both maximally compliant and effective.
Principal Investigator Human Subject Items to Consider When Developing the DMS Plan
- Review NIH Sharing Data from Human Participants
- Consider what factors might limit data sharing
- Informed consent that will not permit or limits scope of sharing or use. Projects are expected to include data sharing requirements in consent forms to the extent possible.
- Privacy or safety of research participants would be compromised and available protections are insufficient.
- Explicit federal, state, local, or Tribal law, regulation or policy prohibits disclosure.
- Restrictions imposed by existing or anticipated agreements with other parties.
- Consider how research participant data will be shared.
- Secondary data may need a DMS plan if it is “new, derived data as a result of their research” with exemptions for primary data that has sharing limitations. See FAQ B.7 under Managing and Sharing Scientific Data for more information.
- Consider how research participants will be informed their data will be shared (i.e., de-identified using HIPAA de-identification standard or identifiable. This is managed by the research team.)
- How will this be addressed in the informed consent form and the IRB application?
- You can find sample NIH/DMSP informed consent language on the IRB website in the Example Informed Consent Language document.
- When submitting an NIH funded proposal to the UCCS IRB include your DMS plan to the IRB for general awareness. Please note the IRB may ask some follow-up questions or make requests to ensure the DMS plan follow federal regulations and campus policies.
- If using Genomic Data, review NIH Genomic Data Sharing Policy.
If you have questions about sharing human subjects data or the IRB application process, please reach out to the IRB@uccs.edu.
Data Management and Sharing Plan FAQs
UCCS and CU Resources
- UCCS DMSP Awareness Sheet
- Finding an Open Repository for Data Research from Kramer Family Library
- For assistance contact Norah Mazel
- Sample DMS Plans based on NIH examples
- Other CU Resources:
- NIH Resources to Prepare Applicants for New Data Management Sharing Policy - Includes sample plans, a two-part webinar series, FAQs, and a list of data repositories
- NIH Sample Plans
- NIH Budgeting for Data Management and Sharing
- NDA Cost Estimation Tool
- NIH Sharing Data from Human Participants
- NIH Supported Data Repositories
- Resources to help you find an appropriate repository for your research
- NIH Data Management and Sharing Tips Resources
- NIH Data Management and Sharing FAQ
- NIH Data Management and Sharing Plan vs. Resource Sharing Plan
- NIH Links to Supplemental Information
- NOT-OD-21-014 – Elements of an NIH Data Management and Sharing Plan
- NOT-OD-21-015 – Allowable Costs for Data Management and Sharing
- NOT-OD-21-016 – Selecting a Repository for Data Resulting from NIH-Supported Research
- NOT-OD-23-070 – NHLBI Supplement to the NIH Policy for Data Management and Sharing (Table)
- OSF Working Group on DMSP Guidance - Includes policy readiness checklist for librarians and researchers and other resources