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Research Data Management NIH Data Management and Sharing Policy

NIH Policy for Data Management and Sharing

What's in the policy?

NIH grants submitted on or after January 25, 2023 must adhere to the new Data Management and Sharing (DMS) Policy. The policy applies to all UAB grant submissions to the NIH that will generate scientific data. Applicants will be required to submit a two-page data management and sharing plan. 

There are notable differences from earlier NIH policies:

  • Changes in format and broader in scope
  • Required for all NIH grant submissions if the grant will generate scientific data
  • Defines what is and is not data (see below)
  • Asks PI to maximize appropriate data sharing
  • Data must be made available at the time of publication or at the conclusion of the granting period, whichever comes first

 

 

The final DMS Policy defines Scientific Data 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.”  


Does my proposal need a DMS plan?

If your proposed project generates scientific data, you will likely need a DMS plan.

Still not sure, check out this complete list of activity codes.


 

Webinars on the NIH DMSP

Watch our training webinars on the new NIH DMSP 

A fresh look at the NIH DMS policy

CCTS TIERS webinar. December 2023. Updated overview of the policy and of the NIH's reception of DMS plans in the first year of the policy.

Recording

Slides

2023 and Me: Part 1

Overview of the policy including which data should be shared and where, and how the policy will affect grant submissions

Part 1 recording

Download the slides from the Part 1 (pdf)

Download the answers to all questions posed in the Part 1 webinar chat log (pdf)

 

2023 and Me: Part 2

Review of example plans written by and for UAB researchers followed by an extended Q&A session with the UAB DMSP task force

Part 2 recording

Download the slides from Part 2 (pdf)

Download the answers to all the Q&A questions (pdf)

 

 

Policy details


How does the DMS policy affect grant submissions? 

  • You can request funds for DMS costs
  • DMSP is reviewed by NIH staff
  • the DMSP does not impact scoring
  • The DMSP may be updated as the project evolves
  • Non-compliance may impact future funding decisions for the recipient institution

What data should be shared?

  • Appropriate data to validate and replicate findings from published studies
  • Data from a study even if not directly linked to a publication
  • Null findings that do not result in publication

What doesn't fall under the policy?

  • Laboratory notebooks
  • Preliminary analysis/optimizations
  • Case report forms
  • Physical objects or specimens
  • Manuscript drafts or correspondence

What are acceptable reasons to not share?

Legal

Explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure

Ethical

Concerns around privacy or safety of research participants

Pre-existing consent policies or agreements prohibit sharing of participant-derived material

Technical

Digitization of datasets is impractical


 

The 6 elements of a DMSP

Example Plans

Developed through a collaboration between the RDM librarian and UAB principle investigators. The plans were written before the NIH data management and sharing policy became effective and has not been reviewed by the NIH. 

Example 1. This sample was made by transforming a resource sharing plan into a DMSP for an R21 project. It contains proteomics, metabolomics and sensitive clinical data 

Example 2. Sample plan for an R01 grant studying cardiac function in a murine model system. It contains imaging, transcriptomic, and epigenomic data types. 

Example 3. Sample plan for a K23. The proposed study is a randomized clinical trial with both quantitative and qualitative data. Sensitive data shared via controlled access through a clinical trials data repository.

Example 4. Sample plan for an R01. The proposed study includes both retrospective analysis, prospective biobank collection of bacterial isolates. Major data types include clinical microbiological, clinical case data, and bacterial genomic sequences.

Example 5. Sample plan for an R01 studying bacterial infection in a murine model system. Data types include bacterial genomics, transcriptomics, bioinformatics and image data.

Example 6. Sample plan for an Early Stage Investigator (ESI) R01 cross-sectional study of microbiome, neurology and oral cancers using multiple in vitro and in vivo models. Data types include genomics, gene and protein expression profiles and other phenotypes.

Example 7. Sample plan for an R01. The proposed study is a Multiphase Optimization Strategy (MOST) randomized clinical trial.

 

Other examples from outside UAB

Sample plans written by NIH institutes/centers

DMSP template

Fill out the template below to craft your DMS plan following the 2023 NIH guidelines

 

DMPTool


 

DMPTool provides templates that can be used in developing Data Management Plans that meet the requirements for grant applications sent to US federal funding agencies. 

Update an existing DMS plan

An active DMS plan must be formally revised if/when your plans for data management and sharing change, for example, sharing data to a different data repository, sharing more/less data than originally planned, adding a data type, etc.

Awardees should work with their OSP federal grants officer to submit changes via the Prior Approval Module of eRA Commons (see offical notice NOT-OD-23-185 and eRA instructions). These prior approvals must be submitted by an OSP federal grants officer 30 days prior to the requested change’s planned effective date. 

Additional Resources