New 2023 NIH Policy for Data Management and Sharing

NIH has issued a new Data Management and Sharing (DMS) Policy, effective January 25, 2023. This new policy requires ALL grant applications or renewals that generate Scientific Data (see definition below) to include a data management and sharing plan (DMSP) and budget requests for data management activities when applicable. Additionally, the policy sets an expectation for researchers to share data to the maximum extent possible given certain factors (i.e., legal, ethical, or technical, etc.) which may preclude sharing. This policy differs from the previous 2003 policy which only required grants of $500,000 per year or more in direct costs to provide a brief explanation of how and when data resulting from the grant would be shared. 

DMSP Requirements 

The data management and sharing plan (DMSP) should outline in 2-pages how data will be managed and shared by addressing the following elements:  

  1. data type,  
  2. related tools, software, and/or code,  
  3. standards, data preservation, access,  
  4. associated timelines, access, distribution, or reuse considerations, and  
  5. oversite of data management and sharing. 

 

The DMSP will be submitted with your grant application and assessed by NIH Program Staff (peer reviewers can also comment on the proposed data management budget). The Institute, Center, or Office (ICO)-approved plan will become a Term and Condition of the Notice of Award. As research progresses, the DMSP can be updated and re-approved as it is intended to be a living document. 

NIH Resources 

In anticipation of this new policy, the NIH has created many resources to help researchers prepare for these new requirements. More detailed information on this new policy can be found via the links below:

 

Does the 2023 Data Management & Sharing Policy Apply to My Research?

The NIH Data Management & Sharing (DMS) Policy, effective January 25, 2023, applies to all research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. 

Scientific Data is defined as data 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 includes any data needed to validate and replicate research findings. 
  • Scientific data does 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. 

Scope of Policy 

This policy covers all NIH-supported research regardless of funding level, including: extramural grants, extramural contracts, intramural research projects, and other funding agreements. Therefore, the DMS policy applies to: Research Projects, Some Career Development Awards (Ks), Small Business SBIR/STTR, and Research Centers and does not apply to: Training (T), Fellowships (Fs), Construction (C06), Conference Grants (R13), Resource (Gs), and Research-Related Infrastructure Programs (e.g., S06).  

For more details on research covered by this policy, see the NIH Research Covered by the 2023 Data Management & Sharing Policy page.  

What Can Be Included in the Budget for Data Management and Sharing? 

The Supplemental Policy Information: Allowable Costs for Data Management and Sharing, outlines that funds may be requested for data management and sharing activities in the budget and budget justification sections of an application. To request funds for data management and sharing costs, include a line item in the budget form and a brief summary of the data management and sharing plan as well as a description of the requested data management and sharing cost in the budget justification. Note that all allowable costs will need to be incurred during the performance period.  

For more details on allowable and unallowable costs, see the NIH Budgeting for Data Management and Sharing resource. 

Additionally, a helpful resource, created by the National Academies of Science, Engineering, and Medicine, may be useful when developing a budget for data management and sharing costs: Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data. 

gear2.png As of October 5, 2023, NIH no longer requires the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories.

What Tools & Resources Are Available to Me?

The NIH has provided many FAQs and Supplements to the new policy as well as resources on planning and Budgeting for Data Management and Sharing, Data Management, and Sharing Scientific Data.  Penn State has also formed a committee that will provide researchers with guidance on the new policy. Read this Penn State News article for more information. If you are aware of other resources, please complete this form so that they can be added to the list below. 

Need support with data management plans, data documentation, and data sharing and preservation? The Data Learning Center Data Management Support Team within the Penn State University Libraries also offers resources and tools for creating data management plans as well as sharing data.  

Need support with determining the appropriate data storage option for during your research project?

Additionally, when determining where to store data during a project, Penn State offers tools for determining information classification levels and storage options available: 

Need support with high-performance computing? 

 

Presentations

In addition to the resources provided above, the following presentations give an overview of the policy, available support, and how to create a data management plan. 

Frequently Asked Questions

NIH provides Guidance about allowable costs. There are currently no budget caps on cost. Costs are requested as seperate line item with accompanying justification. 

As of October 5, 2023, NIH no longer requires the use of the single DMS cost line item. NIH recognizes that DMS costs may be requested in many cost categories.

Shared scientific data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first. See NIH's 2023 Data Sharing FAQs for more information.

NIH acknowledges that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Foreseeable limitations should be described when drafting DMS plans. A compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH. See NIH's 2023 Date Sharing FAQ page for justifiable reasons to limit sharing. 

See exceptions above.

The DMS Plan will likely be submitted prior to IRB during the proposal submission process. IRB is aware of the NIH DMS Policy. Data management activities outlined in the IRB Study Protocol should align with what is written in the DMS Plan that is submitted to NIH.

This is a known service gap at PSU. Researchers can budget for this as an allowable cost if their lab/group are not able to perform deidentification.

No. Only applies to new proposals going forward.

Element 6, “oversight,” of the DMS Plan should describe how the Principal Investigator (PI) and/or CO-Is will monitor and manage the DMS Plan. This section should not list the Office of Sponsored Programs or Office of Research Affairs. PIs are the stewards of the scientific data that is generated as a part of their sponsored research. This means that the PI is responsible for the oversight of the data management and sharing plan, and the implementation of said plans, for their research projects. 

Oversight of DMS Plans includes:

  • Awareness of the elements listed in the DMS Plan
  • Sharing the DMS Plan with study team members
  • Ensuring that data management and sharing activities follow what is listed in the DMS Plan
  • Modification of DMS Plans if data management and sharing activities change throughout the duration of the project (e.g., a different data repository will be used than what is listed, there are new limitations on what data can be shared, etc.).
  • Working with authorized institutional officials (e.g., your grants and contracts office) to submit DMS Plan modifications to have them reapproved by NIH Program Officers.

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The current policy is from 2003. See more information here. Toggle between applications before/after Jan 25th 2023 to compare.