- What should I be doing now?
- The DMS Plan
- When should data be shared?
- What happens if I don’t comply with the policy?
1. Evaluate your personal needs and timelines. Suppose you have plans to submit an NIH proposal after January 25, 2023, or you have an active NIH award up for renewal after January 2023. In that case, you should be actively focusing on developing DMSP plans. This is especially important if you are working with external collaborators as it may take additional time to finalize data procedures and data sharing agreements. Additionally, the IRB may ask for elements from the DMSP as part of their review if human subjects are involved in your research. It is highly recommended you complete the DMSP prior to seeking IRB approval or renewal.
2. Discuss the new requirements with colleagues—reach out to colleagues and collaborators at CNE, locally, and further afield. Understand how they’re managing the new requirements and how you can utilize best practices in your data management processes.
3. Utilize the resources available to you. Familiarize yourself with the CNE resources such as the Research Roundup, The CNE Research Community Workspace on Teams, and the Research Administration Website. NIH has a robust Data Sharing Website ; additional resources can be found in the resources section below.
4. Designate a data manager. Identify one individual who will develop expertise in data management processes and procedures specific to your needs. This individual should also assist in evaluating current data management practices relative to the DMS Policy, especially around documenting existing practices and developing new ones to address the increased emphasis on data sharing and administrative oversight.
5. Reach out to us as soon as possible to review current data services and capabilities and assess whether they will meet your needs. If you identify specific tools or resources that would facilitate data management and data sharing for your lab members, they will need to be vetted by IS, so early engagement is key. While reviewing data/IS needs you should also consider costs you may need to work into current or proposed budgets, such as those for additional labor (data cleaning, documentation, etc.) or other NIH allowable costs (see Budget section below).
6. Request a risk assessment for your chosen repository. Submit a Vendor Risk Assessment request through ServiceNow so that IS can evaluate the repository. Refer to the NIH Data Management Checklist for more details.
As part of the NIH DMS Policy, researchers are required to submit a Data Management and Sharing Plan (DMSP) when applying for funding or renewal (after January 25, 2023) that details how scientific data will be managed and shared. More details can be found here.
DMPTool is a resource to assist in writing DMS Plans. The tool provides sample language, templates, and guidance. To access the CNE managed version of the site, create an account using your carene.org credentials.
The plan should include the following elements:
- Data Type
- Related Tools, Software, and/or Code
- Data Preservation, Access, and Associated Timelines
- Access, Distribution, and Reuse Considerations
- Oversight of Data Management and Sharing
NIH recommends the DMSP be no longer than two pages in length. A recommended draft format template is available here.
The expectation is researchers will work to maximize the appropriate sharing of scientific while considering factors such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation.
Applications subject to NIH’s Genomic Data Sharing (GDS) Policy should also address GDS-specific considerations within the elements of a DMS Plan.
The DMSP will be reviewed by NIH program staff and will not be part of scientific peer review unless data sharing is integral to the proposed project.
If funded, the DMSP will become part of the terms and conditions of the award.
The informed consent process will need to include language specific to scientific data sharing and reuse.
**You should consult with IS early in the writing process to collaborate on any specific needs to implement your DMSP and to receive an IS risk assessment of your repository. They should be part of the development DMSP, not problem solvers after the fact.
Making data accessible and reusable may incur costs. Allowable, reasonable costs related to data management and sharing may now be included in application budgets and justifications.
Reasonable, allowable costs may be included in NIH budget requests for:
- Curating data
- Developing supporting documentation
- Formatting data according to accepted community standards, or for transmission to and storage at a selected repository for long-term preservation and access
- De-identifying data
- Preparing metadata to foster discoverability, interpretation, and reuse
- Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management and preservation (for example, before deposit into an established repository).
- Preserving and sharing data through established repositories, such as data deposit fees.
- If the Data Management & Sharing (DMS) plan proposes deposition to multiple repositories, costs associated with each proposed repository may be included.
Note that all allowable costs submitted in budget requests must be incurred during the performance period, even for scientific data and metadata preserved and shared beyond the award period.
- Budget requests must NOT include:
- Infrastructure costs that are included in institutional overhead
- Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data.
- Costs that are double charged or inconsistently charged as both direct and indirect costs
The National Academies of Science, Engineering, and Medicine has developed a resource "Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data" that may be useful when budgeting for data management and sharing costs.
NIH encourages scientific data to be shared as soon as possible, and no later than the time of an associated publication or end of the performance period, whichever comes first. NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.
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.
Once funding is awarded, the approved DMSP becomes part of the terms and conditions of your award. You must comply with the DMSP and document that compliance in reports such as the annual Research Performance Progress Report (RPPR). Non-compliance may result in enforcement action from the NIH such as
- Addition of special terms and conditions to the award
- Termination of the award
Non-compliance may also affect future funding decisions. To avoid possible issues when reporting progress, ensure that your submitted plan contains enough detail for the program officer to be able to evaluate compliance.
If you make changes to your submitted plan, your new plan must be re-approved. Instructions on how to make changes to an approved plan can be found here.
Data Management Channel on The CNE Research Community Workspace, powered by Microsoft Teams. Click here to join!
Protecting Privacy when Sharing Human Research Participant Data
Reasonable Management and Sharing of American Indian/Alaska Native Participant Data
FASEB DataWorks! Data Management Plan (DMP) Challenge Evaluation Rubric
- NNLM Creating Data Management Plans with DMPTool
Webinars, Articles, and Presentations
NIH Data Management and Sharing Webinars and PPT presentation
“Update on the NIH Policy for Data Management & Sharing and Implementation Activities”
“Understanding the 2023 NIH Data Management and Sharing Policy”
“Update on Implementation of New NIH Data Management and Sharing Policy”
2022 Blalock Lecture Series: “The New NIH Data Sharing Policy”
"Ten simple rules for maximizing the recommendations of the NIH data management and sharing plan"
Harvard Data Science Review: “Changing the Culture on Data Management and Data Sharing in Biomedicine”