NIH Data Management and Sharing Policy Information

Overview

NIH has issued the(effective January 25, 2023) to promote the sharing of scientific data. Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies.All research, funded or conducted in whole or in part by NIH, that results in the generation of "scientific data" must comply with this policy; training grants, fellowships, conference grants and more are not subject to the DMS Policy. Please consult your OCG Proposal Analyst for more information. Please note that it is expected that thePI will beresponsible for managing and sharing data in compliance withthe DMS Plan incorporated into the award terms and conditions.

Under the DMS policy, NIH expects that investigators and institutions:

  • Plan and budget for the managing and sharing of data, which must be included with the proposal
  • Submit a DMS Plan for review when applying for funding at proposal; DMS plan may be revised at the Just-In-Time phase
  • Comply with the approved DMS Plan which will be incorporated into the award terms & conditions; NIH to ask for updates during the annual progress report (RPPR)

Individual NIH Institutes, Centers, or Offices may have additional policies and expectations (see).​

What is Scientific Data?What is NOTScientific Data?

"Scientific data" is defined 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 will vary depending on the project and the context. Potential examples ofscientific datamay include, but are not limited to:

  • Single-cell RNA sequencing (scRNA-seq) of T lymphocytes or other immune cells in a study of HIV/AIDS
  • Electrophysiological recordings and fMRI images in a study of a rodent model of PTSD
  • Step activity from a wearable device in a study of cardiovascular health

Scientific data donot include:

  • Data not necessary for or of sufficient quality to validate and replicate research findings,
  • Laboratory notebooks,
  • Preliminary analyses,
  • Completed case report forms,
  • Drafts of scientific papers,
  • Plans for future research,
  • Peer reviews,
  • Communications with colleagues, or
  • Physical objects, (e.g., laboratory specimens)

Secondary Data:Secondary data may need a DMS plan if it is “new, derived data as a result of their research” with exemptions for primary data that has sharing limitations. See for more information.

When should I share my scientificdata?

Scientific data should be shared as soon as possible, but no later than the time of apublication of findingsin a peer-reviewed journal OR at theend of the award, whichever comes first. The publication date is considered to the be when the article is first available via print or electronic format.Does a pre-print article trigger this requirement? No, this requirement is only applicable to a published, peer-reviewed article. Scientific datathat wasn't published should be shared by end of award, so then pre-print data may be required if data isnot published by end of award.

Applicability

The DMS Policy applies to all research that generates scientific data, including Research Projects, some Career Development Awards, SBIR/STTR, and Research Centers. The DMS Policy does not apply to research and other activities not generating scientific data, including Training Grants, Fellowships, Construction (C06), Conference Grants, Resource (Gs), and Research-Related Infrastructure Programs.

Proposal Development

Please notifyyour OCG Proposal Analystas early as possible in advance of the deadline and review theNIH Required Documents PI Checklistfor all current proposal requirements, to ensure new DMS Policy requirements are being addressed in both the proposal and proposal budget.

Proposal requirements include:
The DMS Plan must include the following elements within the recommended 2-page limit, and the should be used to build your DMS Plan:
  1. Data Type
  2. Related Tools, Software and/or Code
  3. Standards
  4. Data Preservation, Access, and Associated Timelines
  5. Access, Distribution, or Reuse Considerations
  6. Oversight of Data Management and Sharing - Note: It is expected that PI is responsible for oversight of DMS.

Before exporting your DMS Plan from the , PIs must ensure that NIH formatting requirements are specified in the "Download" tab; . NIH formatting requirements include 0.5" (13mm)margins and Arial font at size 11.If questions exist about the completion of the DMS Plan in the DMPTool, please contactCRDDS.

The DMS Plan will not be included in the materials sent to peer reviewers, unless data sharing is integral to the project design and specified in the Funding Opportunity Announcement. The DMS Justification included in the Budget Justification will be available to reviewers though, which includes a summary of the DMS plan.

Budgeting for the DMSP

Please work with your OCG Proposal Analyst and utilize the NIH Cost Estimation Tool to develop your budget and to ensure DMS costs are appropriately addressed. CRDDS is available for consult to determine applicable costs, review your DMS Plan, and direct you to appropriate repositories and resources while helping you determine costs. Please reach out to CRDDS as early as possible in the proposal processif seeking their assistance.

Allowable Costs:Unallowable Costs:
  • 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
  • Preserving and sharing data through established repositories (ex: data deposit fees). If proposing multiple repositories, costs associated with each may be included
  • Infrastructure costs that are included in institutional overhead (for instance,)
  • 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

DMS Requirements for R&R Detailed Budgets:

Please use the OCGNIH Cost Estimation Tool for creating all NIH budgets for proposed research funding and the OCGBudget Justification Templateor the OCG Additional Narrative Justification Template to develop the budget justification.

Update for all research proposals due on/after 10/05/23 that require a DMS Plan: While “Data Management and Sharing Costs” are no longer required as a separate line item in the R&R budget, the total DMS cost estimate must be specified within the Budget Justification. The OCGBudget Justification Templateshould be used to developthe detailed Budget Justification, and the "Data Management and Sharing Justification" section must be completed even if no costs are proposed. If applicable, the Justification must specify if no DMS costs will be incurred. The DMS Justification must also briefly explain any personnel effort and costs associated with general cost categories: curating data and developing supporting documentation, local data management activities, preserving and sharing data through established repositories, etc. Subrecipients should include a DMS Justification in their Budget Justification as well and provide the same DMS Justification details.Please refer to theBudget Justification Templatefor detailed guidance on what information is needed.

DMS Requirements for Modular Budgets:

For NIH research proposals requiring a DMS Plan, NIH Modular Budgets will be used when the NIH budget is $250,000 or less in Direct Costs per year of the budget (unless the FOA requires a detailed budget or Human Fetal Tissue is proposed in the project).For theNIH Modular Budget, PIs may choose to use the OCG NIH Modular Budget Template or the detailed OCG NIH Cost Estimation Tool to develop their internal budget.

However, all costs must be included in the now required Additional Narrative Justification under a section titled "Data Management and Sharing Justification" with all costs detailed and a brief summary of the DMS Plan provided; full instructions are provided in the OCGAdditional Narrative Justification Template’s "Data Management and Sharing Justification" section. If no costs will be included in thebudget, then this should be clearly iterated in the DMS Justification within the Additional Narrative Justification. Any subrecipient costs specific to DMS should be discussed in the Additional Narrative Justification as well.

Just-In-Time (JIT)

The DMS Plan will likely need to be revised during the JIT stage, prior to an award being made. NIH Program Officers (POs) will work with PIs to resolve issues and finalize the plan based on the PO's assessments. Once POs and PIs agree on the DMS Plan, it is then resubmitted as a JIT by your OCG Proposal Analyst.

Post-Award,Prior Approval andResearch Performance Progress Report (RPPR)

If an award is made, the approved DMS Plan will become a term and condition of the award and the PI is responsible for managing and sharing data as described in the DMS Plan and for overall compliance with the DMS Plan.During the funding period, compliance with the Plan will be determined by the NIH Institute or Center.

If changes are needed to your DMS Plan after award,please work with your OCG Grant Officer.Prior approval from the NIH Program Officer along with the revised DMS Plan are required when the following changes occur to the plan:

  • New Scientific Direction
  • Change in Data Repository
  • Timeline Revision

Compliance with the Plan, including any Plan updates, may be reviewed during regular reporting intervals (e.g. at the time of the annual RPPR).Please contact ocgreports@colorado.eduwhen submitting a NIH RPPR.​

Resources

CU «Ƶ Resources:

NIH Resources:

  • - CRDDS is also able to assist in selecting a data repository.
  • NIH FAQs: