NIH Data Management and Sharing Policy
Background
In October 2020, the Final NIH Policy for Data Management and Sharing was released. This policy requires submission of a Data Management and Sharing Plan at the time of proposal as well as release of the data, whether access is open or controlled, to be made "no later than the time of an associated publication, or the end of the award/support period, whichever comes first." When this policy goes into effect in January 2023, awards will include the approved DMS Plan in the Terms and Conditions, at which point IU will become legally responsible for complying with the DMS Plan. More information about the IU Research Data Management Plan Working Group is available in the IU RDMP Working Group section of this policy.
Supplementary information was released alongside the policy, listed below.
NOT-OD-21-014 – Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan
NOT-OD-21-015 – Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing
NOT-OD-21-016 – Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research
In April 2022, the NIH launched a new website on data sharing.
NOT-OD-23-161 – Updated Instructions to the NIH Policy for Data Management and Sharing Costs (released July 31, 2023)
Back to topIU Research Data Management Plan (RDMP) Working Group
In the fall of 2021, the IU Research Data Management Plan Working Group was convened to address the NIH DMS Policy. We are providing presentations to inform all stakeholders about the Final NIH Data Management & Sharing (DMS) Policy and gather input identifying specific challenges, opportunities, and supports needed to comply with the NIH DMS Policy.
While many units have requested synchronous presentations, we recognize that not everyone is able to attend those sessions. A recorded version of our presentation is available in Kaltura.
Key Policy Details
- Beginning January 25, 2023, all funding proposals that result in the generation of scientific data to the National Institutes of Health must include a Data Management and Sharing (DMS) Plan.
- DMS Plans must be submitted at the time of application. DMS Plans should be uploaded in the designated form field as outlined in the most appropriate NIH Application Guide (SR424) for more information. They will be included in the Budget Justification section.
- The DMS Plan will become a Term and Condition of the Notice of Award.
- The DMS Plan should describe a plan for managing and sharing the resulting scientific data. If you do not plan to share, provide a rationale for why data sharing is not possible. In the context of this policy, data sharing refers to making data available to people beyond the project personnel.
- There is a new definition of scientific data: “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 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.”
- While this policy does not supersede the need to protect the confidentiality and privacy of participants, the NIH is strongly encouraging researchers to consider options for sharing human subjects data that retain those protections, such as de-identification or controlled access sharing.
- The timeline for sharing data is very specific - "no later than the time of publication or the end of the award or support period, whichever comes first."
Elements of a DMS Plan
1. Data type
2. Related tools, software, or code
3. Standards
4. Data preservation, access, and associated timelines
5. Access, distribution, or reuse considerations
6. Oversight of data management and sharing
Guidance & Support
Available Resources
- NIH's Data Management & Sharing Policy Overview Website – This website includes information on planning/budgeted, the submissions and review process, as well as, implementation.
- NIH's Writing a Data Management & Sharing Plan Website – This website outlines how to write and submit your Data Management & Sharing Plan, including a DMS Plan format page you can use, descriptions of the required sections and sample plans.
- IU's Fillable DMS Plan Form – This form walks you through the different required sections and will allow you to print out a copy of the DMS Plan that you can attach to your proposal.
- IU's Data Management & Sharing Plan Guidance website – This website outlines each of the required sections of the DMS Plan, including the policy descriptions, IU guidance and samples responses.
- DMP Tool - This is a free, open-source, online application that helps researchers create data management plans. The tool provides a click-through wizard for creating a DMP that complies with funder requirements. It also has direct links to funder websites, help text for answering questions, and data management best practices resources.
Uploading your Plan to your Application
Depending on the type of application (Research, Career, Training or Fellowship) your plan could be uploaded into different forms within your proposal application. The appropriate field, regardless of the form, should be labeled Other Plan(s). Please see the NIH Application Guide for specific information on where to upload the form for your application.
Budgeting for your DMS Plan Costs in your Application - Prior to October 5, 2023
NIH is requiring you to address your Data Management & Sharing costs on all impacted proposals, which includes listing a specific dollar amount for DMP plan requested costs, providing a brief summary of the DMS plan as well as a description of the DMS costs.
For R&R Budgets:
- Costs should be budgeted in the "Data Management and Sharing Costs" line item under Other Direct Costs "8-17 Other" on the R&R Budget Form.
- Costs should be justified in the Budget Justification attachment and include a brief summary of the DMS plan and a description of the DMS costs.
For Modular Budgets:
- Costs and justification should be included in the Additional Narrative Justification attachment of the PHS 398 Modular Budget Form, which includes a dollar amount of the needed costs, a brief summary of the DMS plan and a description of the DMS costs.
Budgeting for your DMS Plan Costs in your Application - On or After October 5, 2023
NIH is requiring you to address your Data Management & Sharing costs on all impacted proposals, which includes listing a specific dollar amount for DMP plan requested costs, providing a brief summary of the DMS plan as well as a description of the DMS costs.
For R&R Budgets:
- Costs should be budgeted in the appropriate cost category, e.g. personnel, equipment, supplies, and other expenses on the R&R Budget Form. DMS costs should no longer be budgeted as a single cost line item.
- Costs should be justified in the Budget Justification attachment and include a brief summary of the DMS plan and a description of the DMS costs.
For Modular Budgets:
- Costs and justification should be included in the Additional Narrative Justification attachment of the PHS 398 Modular Budget Form, which includes a dollar amount of the needed costs, a brief summary of the DMS plan and a description of the DMS costs.
The NIH Application Guide states that costs justifications should include:
- A brief justification of the proposed activities that will incur costs
- A brief summary of type and amount of scientific data to be preserved and shared and the name of the established repository(ies) where they will be preserved and shared.
- Including indicating general cost categories such as curating data and developing supporting documentation, local data management considerations, preserving and sharing data through established repositories, etc., including an amount for each category and a brief explanation.
Allowable Costs include:
- 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
Unallowable Costs include:
- Infrastructure costs that are included in institutional overhead (for instance, Facilities and Administrative costs)
- 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
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