NIH Data Management and Sharing Policy

 

NIH Data Management and Sharing Policy

The 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 the 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

A Data Management and Sharing Plan that 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. Monitoring and Management
    2. Specific People Responsible
    3. How often

Budget  

NIH Link: Budgeting for NIH Data Sharing and Management Plan

  1. Single Line item on the budget form
    1. Allowable costs include labor for data curation, de-identification, preservation, etc.
    2. Costs must be paid upfront before the end of the performance period (i.e. repository fees)
  2. A brief summary of the DMS Plan and a description of the requested DMS costs in the budget justification
  3. Note: Budget and justification will be seen and reviewed by scientific reviewers.
  4. Budget resources and tools
    1. NIMH Data Archive (NDA)’s budgeting guide 
    2. NIMH Data Archive (NDA) Data Submission Cost Estimation Tool  Excel sheet download wtih example of cost calculations specifiec to the NIMH NDA
    3. European Based OpenAire Guide. Provides examples of costs. This tool provides examples in Euros and would need to be translated to USD.

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 January 17, 2023

Presentation recording from January 17, 2023

Questions about sharing human subject data

 

Who do I contact with questions?

 

Helpful Links

 

 

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