The NIH has implemented a new Data Management and Sharing Policy which changes the requirements for all proposals submitted on or after January 25, 2023. After that date, each NIH grant proposal which will generate scientific data must include a Data Management and Sharing  Plan (DMSP) outlining how that data and any accompanying metadata will be managed and shared, taking into account any  potential restrictions or limitations. This includes information on data storage, access policies/procedures, preservation, metadata standards, distribution approaches, and more. 

The DMSP will be assessed by NIH Program Staff and are NOT a part of the scored peer review process unless specifically noted in the Funding Opportunity Announcement (though peer reviewers will be able to comment on the proposed data management budget). The Institute, Center, or Office (ICO)-approved plan becomes a Term and Condition of the Notice of Award.

(This page was last updated 12/16/2022)

First, determine if NIH's new policy will apply to your research. Check NIH's reference tool about Research Covered Under the Data Management and Sharing Policy.

If you plan to generate scientific data, you must submit a Data Management and Sharing Plan (DMSP) to the funding NIH ICO as part of the Budget Justification section of your application for extramural awards. 

Your plan should be two pages or fewer and must include:

• Data Type

• Related Tools, Software and/or Code

• Standards

• Data Preservation, Access, and Associated Timelines

• Access, Distribution, or Reuse Considerations

• Oversight of Data Management and Sharing.

To draft the plan itself, we recommend the DMPTool using the NIH 2023 template. (Note: The Genomic Data sharing components are still being worked on by the NIH DMPTTool Working Group as of 12/15/2022.) Enter your Lehigh username and click "Continue" to login using Lehigh's SSO. You can save plans for customization on a project-by-project basis. Additional guidance for completing each section of the template will be added to the DMPTool on a rolling basis. 

If you are including institutional services and tools in the DMSP, be sure to budget for any associated costs. 

Any costs related to complying with the policy must be paid for up-front during the performance period. For example, costs for long-term data preservation must be budgeted for in the proposal and paid before the end of the grant. You may find the NIHM Data Archive (NDA) cost estimation worksheet useful.

NIH provides sample plans here. 

NIH states that researchers should “maximize the appropriate sharing of scientific data generated from NIH-funded or conducted research, consistent with privacy, security, informed consent, and proprietary issues.”

The new policy requires a plan for maximizing the sharing of Scientific Data while acknowledging factors (legal, ethical, or technical) that may affect the extent to which it can be shared. The policy does not state that all data needs to be shared openly, meaning without restriction on who can reuse the data and for what purpose. However, restrictions on data sharing need to be outlined in the data management and sharing plan.

If you are conducting research with human subjects, you must incorporate consent during the data management and sharing process, even if data will be de-identified. If you are conducting research with American Indian, Alaska Native, or Indigenous populations, you must secure appropriate agreements with tribal authorities before using and sharing that information.

NIH 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.

NIH encourages scientific data be shared as soon as possible, and no later than time of an associated publication or end of the performance period, whichever comes first. NIH also encourages researchers to make scientific data available for as long as they anticipate it being useful for the larger research community, institutions, and/or the broader public.

Additionally, the US government has issued a broad open access policy for federally-funded research, with the 2022 OSTP (Nelson) Memo mandating that  "all peer-reviewed scholarly publications [and their supporting data] authored or coauthored by individuals or institutions resulting from federally funded research are made freely available and publicly accessible by default in agency-designated repositories without any embargo or delay after publication" no later than December 31st, 2025.

The NIH encourages deposit into repositories that support effective data discovery and reuse, and provides guidance for Selecting a Repository for Data Resulting from NIH-Supported Research, as well as lists of recommended repositories:

• Discipline or data-type specific repositories (a number of programs and center data sharing policies do specify repositories).
• Generalist repositories, including institutional repositories, such as Lehigh's Digital Repository, Preserve.

For data storage, LTS offers cloud file storage options.  Lehigh's Office of Institutional Research and Strategic Analytics (OIRSA) provides additional guidance regarding classification of data.

Before submitting your data to your chosen repository, you will need to ensure you've completed these steps.

• De-identify your data if appropriate.
• Document the dataset thoroughly in a separate readme.txt file, and/or create metadata according to the scheme required by your chosen repository.
• Obtain a DOI or other permanent identifier (such as ORCID) for the dataset from your chosen repository. Contact Jasmine Woodson at jasmine@lehigh.edu for assistance. 
• Follow the upload instructions for your chosen repository.

Keep in mind that research proposals without a Data Management and Sharing Plan will not be considered for funding. 

You must comply with the IC-approved plan and document your compliance in your annual Research Performance Progress Report (RPPR). Failure to provide updates may result in an enforcement action from the NIH such as additional special terms and conditions or termination of the award. 

Non-compliance may also impact future funding 

If you need to alter your submitted plan during the life of your project, you must submit your new plan and receive re-approval. Check with your ORSP Contract and Grant Specialist on how to make these changes.

LTS has assembled a group of staff including librarians, research computing professionals, data security specialists, and computing consultants in order to provide DMP assistance. We are able to:

• Share resources relevant to drafting DMPs
• Review and discuss working drafts of DMPs 
• Create and assign DOIs for datasets
• Identify relevant repositories for data preservation and accessibility. LTS can also make the Lehigh Preserve available either as a backup to these other repositories, or as the primary repository. LTS recommends however that to the extent possible, publicly accessible subject repositories should have primacy of consideration, just from the standpoint that subject repositories may enhance discovery by other subject specialists outside Lehigh.
• Advise on metadata creation (see OSTP Nelson Memo, Section 4a for further information)

In addition to the NIH Data Management Policy site, the NIH Grants Youtube channel is an available resource to learn more about grant opportunities and requirements.

We do recommend that detailed questions about NIH requirements be directed to NIH, but for other questions or requests for assistance please use the following contacts:

• Research Data Plans and Management - email data-management-group-list@lehigh.edu
• Data Security - Eric Zematis, Chief Information Security Officer
• Data Storage -  the Help Desk or your Computing Consultant.

For assistance with grant proposal writing in general, contact Kate Bullard, Ph.D., Research Program Development Officer, Office of the Vice Provost of Research.

This page was adapted from Cornell University's Research Data Management website and Arizona State University's NIH DMSP library guide via a CC BY 4.0 license.