NIH Data Management and Sharing Policy

 

NIH Data Management and Sharing Policy

NIH has issued a new policy effective for all grant applications and renewals submitted that generate scientific data starting January 25, 2023.  Previously, grants over 500K in direct costs required a brief description of how data would be shared.  The new policy requires a detailed plan that is reviewed by NIH.

Scientific Data is defined in the policy as "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."

Scientific data should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the performance period of the extramural award that generated the data. 

Your plan may be subject to additional NIH Institute and Center Data Sharing policies. Please check the web site of the Institute you are applying to for specifics regarding repositories, etc. 

Required Elements

NIH Link: Elements of an NIH Data Management and Sharing Plan

The Data Management and Sharing Plan is up to 2 pages in length and includes:

  1. Data Type 
    1. Summarize the types and amount of scientific data to be generated and/or used in the research. Describe which scientific data from the project will be preserved and shared. The plan should provide the reasoning for these decisions.  A brief listing of 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
    2. Genomic data sharing plan is now part of this document: Implementation Changes for Genomic Data Sharing Plans
  2. Related Tools, Software and/or Code
    1. 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. If applicable, specify how needed tools can be accessed.
  3. Standards 
    1. Describe what standards, if any, will be applied to the scientific data and associated metadata (i.e., data formats, data dictionaries, data identifiers, definitions, unique identifiers, and other data documentation).
    2. NIH Data Management Guidance
    3. NIH Common Data Elements Webinar: Standardize Your Research with the NIH Common Data Element Repository 
  4. Data Preservation, Access, and Associated Timelines
    1. Selecting a Data Repository
    2. NIH information on Repositories
    3. The name of the repository(ies) where scientific data and metadata arising from the project will be archived. 
    4. How the scientific data will be findable and identifiable, i.e., via a persistent unique identifier or other standard indexing tools.
    5. When the scientific data will be made available to other users and for how long. Identify any differences in timelines for different subsets of scientific data to be shared
    6. Data must be shared no later than the time of an associated publication or at the end of the performance period, whichever comes first. Include in the plan a description of which repository unpublished data will be shared in at the end of the performance period.
  5. Access, Distribution, or Reuse Considerations
    1. Describe any applicable factors affecting subsequent access, distribution, or reuse of scientific data including informed consent, privacy and confidentiality protections, legal restrictions, if access is controlled, etc.
    2. Special Considerations:
      1. Human subject data
        1. Protecting Privacy When Sharing Human Research Participant Data
        2. NIH Guidance on Informed Consent and Sharing Data
      2. American Indian/Alaskan Native
        1. Considerations for Researchers Working with AI/AN Communities
  6. Oversight of Data Management and Sharing
    1. The primary investigator is responsible for ensuring that the DMS plan is executed
    2. Describe how the PI will monitor compliance with the plan including frequency
    3. List roles of people executing the plan including a description of tasks. (e.g., post-doc, research scientist, subaward collaborator, etc.)

 

Individual NIH Institutes, Centers, or Offices may have additional policies and expectations (see NIH Institute and Center Data Sharing Policies).

Templates

NIH template

The Federal Demonstration Project is piloting two templates developed in collaboration with NIH:

FDP Template Alpha

FDP Template Bravo

Budget  

NIH Link: Budgeting for NIH Data Sharing and Management Plan

Data Management and Sharing costs per NIH guidelines are for preparing research data for sharing and sharing data/repository costs.  Costs associated with the routine conduct of research, including costs associated with collecting or gaining access to research data are not allowed per NIH guidelines in the DMS cost section of the budget.

Although DMS Plans will not be seen by peer reviewers, the justification provides details about the plan for reviewers to assess reasonableness of DMS costs. This is the only place in the application the reviewers will see any details of the DMS Plan.

Data Management and Sharing costs must be incurred during the performance period of the project, even though scientific data and metadata shared beyond the award period.

  1. Budget
    1. Allowable costs include:
      1. Repository fees (e.g., data deposition, storage)
      2. Labor for de-identification, data curation (e.g., structuring, indexing, etc.), formatting data, developing supporting documentation and metadata, de-identification,  etc.
    2. Unallowable costs include:
      1. Infrastructure costs
      2. Dartmouth data storage fees
      3. Research data access fees
    3. Costs must be paid upfront before the end of the performance period (i.e. repository fees)
    4.  Budget Format
      1. DMS costs are no longer a separate line item in the budget.
      2.  DMS costs are required to be listed in their respective cost categories such as Personnel (e.g., data curation), or Other Costs (e.g., repository fees).
      3. Personnel costs associated with data management and sharing activities are included in the overall budgeted personnel effort which now includes both the effort to conduct the science of the project and the effort to share the data.
      4. DMS Costs in detailed and modular budgets guide
  2. Justification:
    1. Detailed budget justifications require a section labelled: “Data Management and Sharing Justification”.
    2. Modular budget justifications require a section labelled, “Data Management and Sharing Justification” in the “Additional Narrative Justification” document.
    3. If not requesting costs, include a statement that no costs are being requested for data management and sharing.
    4. If requesting costs:
      1. Include total direct cost requested for Data Management and Sharing.
      2. Name of the established repository(ies) to be used and iInclude summary of type and amount of scientific data to be preserved and shared.
      3. Describe the specific costs (e.g., personnel, repository fees) and an amount assigned for each cost thatare embedded in detailed budget line items or are components of modular requests, For personnel, list only the total cost.
      4. Length no more than ½ page.
    5. DMS Justification checklist and examples

Resource Sharing Plan

The Resource Sharing plan is only required for projects that develop research tools and/or model organisms.  For more specific information (and suggested language if applicable) please see Dartmouth OSP NIH Resource Sharing Plans. 

NIH Review of the DMS Plan

NIH program staff will review the DMS Plan for acceptability and may request modifications prior to award as appropriate. Plans must be approved by the funding institute before award. Scientific reviewers will not see the plan but they will see the budget and budget justification.  The approved plan becomes part of the terms and conditions of the award. 

Updating the DMS Plan

The process for submitting requests to update your plan depends on where you are in the grant award cycle Requesting Revisions to an Approved Data Management and Sharing (DMS) Plan:

  1. Pre-award: Just in time: There is a new Data Management and Sharing Plan Revision section in the JIT screen to upload the revised plan.
  2. Post-Award: RPPR: Within 30 day of RPPR submission, upload the revised plan to section C.5.c  
  3. Post-Award: Off Cycle requests: select “submit a Prior Approval – DMS Request” in the Prior Approval Module in ERA Commons to submit a revised plan

DMS Plan Reporting

Section 5C of the RPPR has been updated to report data sharing activities.  Please see the NIH RPPR instruction guide for specific instructions.

  1. Question C.5.c automatically indicates if the award is applicable to the 2023 NIH DMS policy
  2. For each data type in the plan, report on Data Type, has the data been generated, Has the data been shared, if not, what is the sharing status, repository, and Unique Identifiers/DOI.
  3. Describe any deviations from the plan
  4. Report any prospective changes to the plan and if changes, upload the revised plan

Institutional Resources

Storage/Computing

 

Dartmouth Library Data Management (data organization, choosing a repository, writing a DMSP)

 

Library/OSP Webinar resources:

NIH Data Management Plans and Practices 

Slide presentation from October 10, 2024

Presentation recording from October 10, 2024

OSP Roundtable and NCURA Region I conference slides:

New NIH Data Sharing Plans: What You Need to Know to Support Your Researchers

This presentation includes a case study/example

Slide presentation from May 10, 2023

Questions about sharing human subject data

 

Who do I contact with questions?

 

Helpful Links

 

 

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