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. 

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
  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
  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. Responsible Management and Sharing of American Indian/ Alaska Native Participant Data
  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).


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.

  1. Single Line item including all requested funds labeled “Data Management and Sharing Costs”
    1. Allowable costs include:
      1. Repository fees
      2. Labor for data curation, formatting data, developing supporting documentation and metadata, de-identification,  etc.
    2. Unallowable costs include:
      1. Infrastructure costs
      2. Research data access fees
    3. Costs must be paid upfront before the end of the performance period (i.e. repository fees)
  2. Justification:
    1. Label: “Data Management and Sharing Justification”.
    2. Although your DMS Plan will not be seen by peer reviewers, the justification provides details about your plan for review of reasonableness of budget.
    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 summary of type and amount of scientific data to be preserved and shared and the name of the established repository(ies) to be used.
      2. Use general cost categories such as curating data and developing supporting documentation, local data management activities, preserving and sharing data through established repositories, etc.
         and amount for each category including a breakdown of personnel effort if applicable.
      3. Recommended length no more than ½ page.

Note: Budget and justification will be seen and reviewed by scientific reviewers.


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 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 DMS Plan

If your plan changes, work proactively with your program officer to have the changes approved.  For example, if you choose to submit to a different repository than specified in your plan, this must be approved and an  updated Notice of Award will be issued with the new plan.

DMS Plan Reporting

The RPPR is being updated to include reporting of data deposited in repositories.  Data shared can be cited as products of awards and listed as products of NIH funding.

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 May 2, 2023

Presentation recording from May 2, 2023

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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