NIH Data Management and Sharing Policy (2023)
In an effort to promote and share scientific data, the NIH has established a Data Management and Sharing Policy (DMSP), beginning January 25th, 2023, requiring ALL grant or renewals that generate Scientific Data to include a robust and detailed plan for how you will manage and share data during the entire funded period.
THE NIH EXPECTS THAT INVESTIGATORS AND INSITUTITIONS SPECIFICALLY EXECUTE THE FOLLOWING UNDER THE DMSP :
CHANGES TO APPROVED PLANS REQUIRE PRIOR NIH APPROVAL.
Penn Libraries Can Help!
Penn Libraries has an extensive guide on NIH data management and sharing plan, as well as many helpful resources including support for Research Data Services. The library can also provide advice on choosing a data repository.
Visit the Penn Libraries website for more information and view the video below for further guidance.
Data Management Resources
DMPTool for Data Management Plans
A resource to draft data management plans that meet funding agency requirements.
Determine if your proposed research is subject to the DMSP
Please note that 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.
Access sample templates for various scientific fields
In need of clinical data for research? Via Penn PSOM VPN or UPHS network, learn more about Penn's self-service tools and clinical data sources for research at the Penn Research Analytics Storefront.
- Create your own schedule. Developing a Data Management Sharing Plan should be a high priority for any active NIH awards going up for renewal with a receipt date of January 2023, or submitted NIH proposals this year.
- Familiarize yourself with the policy and the differences taking effect in January 2023.
- Understand the FAIR (findable, accessible, interoperable, reusable) principles.
- Review your own practices that pertain to the new policy.
- Utilize Penn data services to help you meet your needs. This includes items such as computing, storage, and consulting.
A Data Management and Sharing Policy (DMSP) must be included in all new proposals. Execution of your ICO-approved plan and document that work in your RPPR to comply will occur after your funding is awarded.
How to Plan for the Managing and Sharing of Data:
2.) Confirm what data needs to be managed and by whom
3.) Verify the data that is required to be shared under the policy (see the definition of Scientific Data above). As a general rule for data sharing, keep in mind that your data should be "as open as possible, and as closed as necessary".
- Your DMSP should document the following:
The datasets that would be subject to additional privacy controls, the person who will manage such controls, and who all will have access to these datasets.
If applicable, confirm that the Data Use Agreement allows for de-identified data sharing and/or sharing of derived datasets, if possible.
Your consent forms should contain appropriate language, specifically if your research includes human subjects, to ensure de-identified data sharing. See the NIH's guidance on privacy protections and AI/AN populations
Leaders/groups of indigenous populations must approve your plan for collection or use if they are involved in your research.
3.) You are now ready to begin writing your DMSP (see the "Submission" section below for submission details.) The DMPTool is a great resource for creating your plan and includes guidance on what to write in each section of the DMSP.
|You can draft the plan yourself with DMPTool using the NIH 2023 template.|
How to Budget for the Managing and Sharing of Data:
Any costs necessary to carry out the DMSP can be included as a line item in the budget. Additionally, the budget justification must include a short synopsis of the DMSP. The budget justification will justify any costs associated with long term storage of the data for which you are requesting the sponsor to pay. While completing this portion of the DMSP, please reference the NIH provided lists of allowable and unallowable costs.
All costs related to complying with the policy must be budgeted for in the proposal and paid for during the performance period / before the end of the grant. For further assistance, please reference the NIHM Data Archive (NDA) cost estimation tool or the publication Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data.
Step 1: Any current ongoing grants should immediately compare the new requirements to its existing data practices.
Step 2: Please be aware that more intense data management and sharing plans are required in this new policy and remember, that data sharing must be communicated in your updated plan. Additional areas of your grants may need review including: documentation, data use agreements, carving out time for data preparation, etc.
Step 3: Reference the "Planning and Budgeting for New Proposals" section above to draft the plan.
The plan should be two pages or less. To assist, please reference the NIH optional DMS Plan format page.
The following information is required:
- Data Type
- Related Tools, Software and/or Code
- Data Preservation, Access, and Associated Timelines
- Access, Distribution, or Reuse Considerations
- Oversight of Data Management and Sharing
Data Management & Sharing Policy (DMSP)
Unless specifically highlighted in the Funding Opportunity Announcement, plans are NOT part of graded peer review criteria. NIH Program Staff are responsible for the reviewing and approving plans prior to award, and may request prior modification as appropriate. Additionally, these plans must be approved by the funding institute prior to award. The plan itself will have a special spot for upload in the SF-424 application packet for submissions.
For more information of these elements, please view the Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
To improve the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data, the NIH recommends sharing datasets through established data repositories.
Your data should be accessible as quickly as you are able. Additionally, you can use relevant requirements and expectations (i.e. data repository policies, award record retention requirements, or journal policies) to determine when to make your data sets available.
The NIH requires that you share your data when you publish your work or before your performance period ends, whichever comes first, regardless of journal or repository policies.
There are no specific requirements for how you share your data. When your data is shared, you should prioritize the NIH’s goal of making data as accessible as possible. The expectation from the NIH is that all shareable data be made available, whether it is associated with a publication or not.
Please do not share your data if doing so would violate privacy protection or applicable laws.
If that data you share is related to human subjects, your plan must address how data sharing will be communicated in the informed consent process with consent forms, waivers of consent, etc. For additional guidance on consent, see item 8 in the NIH FAQ.
Before submitting your data to your chosen repository, you will need to:
- Rationally group your data in sections for citation and reuse. This allows for ease in assigning a persistent identifier(s) (e.g., DOI) to the dataset. The use of persistent identifiers for datasets are strongly encouraged by the NIH, as they make it easier for others to cite your data and for the NIH to track compliance.
- Ensure your data complies with privacy regulations.
- Export your data as a .csv or another machine-readable file.
- If applicable, use any appropriate data and metadata standards to your field. View searchable database of standards.
- Record the all dataset information in a separate readme.txt file / generate metadata adhering to the format required by your chosen repository or discipline.
Compliance & Institutional Oversight
Compliance with the ICO-approved plan and documentation in the annual Research Performance Progress Report (RPPR) is required. Non-compliance may result in :
- Additional terms and conditions to the award
- Cancellation of the award
- The potential to affect future funding decisions
In order to avoid possible issues when reporting progress, make sure that your submitted plan contains enough information that the program officer can evaluate efficiently.
Any changes made to your submitted plan must be re-approved by NIH. (The process varies depending on if the change is made pre-award or post-award.)
Responsibility for overseeing the implementation of DMSPs is flexible with the NIH policy. Although the specifics may vary depending on the project, the following general responsibilities apply:
- Overall responsibility is attributed to the PIs who are required to ensure the execution of DMSP.
- The consistency of sharing of data concerning human subjects between the DMSP and informed consent is ensured by the HSPP/IRB.
- PIs and Sponsored Projects and Contracting ensure the correct data use agreements are established before sharing sensitive data.