Previously, the NIH only required grants with $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.
The 2023 NIH policy is entirely new. Beginning January 25, 2023, ALL grant applications or renewals that generate Scientific Data must include a robust and detailed plan for managing and sharing data during the entire funded period. This includes information on data storage, access policies/procedures, preservation, metadata standards, distribution approaches, and more. You must provide this information in a data management and sharing plan (DMSP). The DMSP is similar to what other funders call a data management plan (DMP).
The DMSP will be assessed by NIH Program Staff (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.
A Data Management & Sharing Plan (DMSP) must be submitted as part of the funding application for all new and competing proposals/renewals that generate Scientific Data for January 25, 2023, and subsequent receipt dates. The term 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."
High-level first steps
If your research requires Institutional Review Board (IRB) approval, the IRB may ask for information contained in your DMSP. Therefore, it is strongly recommended to draft your DMSP prior to seeking IRB approval.
Checklist for Researchers
"This Checklist for Researchers is for use while writing a Data Management and Sharing Plan for NIH grant applications. It provides guide points to be addressed during the writing process and is based on the six required elements."
Unlike NIH's prior policies, 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 new NIH definition of scientific data "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.”
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 recommends sharing datasets through established data repositories to improve the FAIRness (Findable, Accessible, Interoperable, and Re-usable) of the data.
While NIH supports many data repositories, your data may or may not be appropriate for an NIH repository. You should also consider data repositories supported by other organizations, both public and private.
For more information, see:
You will need to share your data when you publish your work or before your performance period ends, whichever comes first.
In general, you should make your data accessible as soon as possible. You can also use relevant requirements and expectations such as data repository policies, award record retention requirements, or journal policies, to decide when to share your data sets.
The policy does not state specific requirements for how you share your data. When you share your data, you should address the NIH’s goal of making data as accessible as possible. The NIH expects all shareable data to be made available, whether or not it is associated with a publication.
All data used or generated as part of a grant must be managed, but not all data should be shared. You should not share data if doing so would violate privacy protections or applicable laws.
You may share data related to human subjects, but your plan should address how data sharing will be communicated in the informed consent process (e.g., consent forms, waivers of consent).
Before submitting your data to your chosen repository, you will need to:
Bundle your data together in logical "chunks" for citation and reuse. Appropriate bundling makes it easy to assign a persistent identifier(s) (e.g., DOI) to the dataset. NIH strongly encourages the use of persistent identifiers for datasets. These identifiers, usually assigned by data repositories, make it easier for others to cite your data and for the NIH to track compliance.
De-identify your data, if appropriate
Convert your data to an open, machine-readable file format such as .csv when possible
Use data and metadata standards appropriate to your field (if any). Refer to fairsharing.org for a searchable database of standards.
Document the dataset thoroughly in a separate readme.txt file, and/or create metadata according to the format required by your chosen repository or discipline
Refer to the Research Data Sharing and Management library guide for help on storing and publishing your research data.
You must comply with the ICO-approved plan and document that compliance in reports such as the annual Research Performance Progress Report (RPPR). Non-compliance may result in enforcement action from the NIH such as
Addition of special terms and conditions to the award
Termination of the award
Non-compliance may also affect future funding decisions. To avoid possible issues when reporting progress, ensure that your submitted plan contains enough detail for the program officer to be able to evaluate compliance.
If you make changes to your submitted plan, your new plan must be re-approved. We will provide guidance from the NIH on the process for making changes soon.
Many thanks to the team at Arizona State University, especially Janice Hermer, for their guide, https://libguides.asu.edu/c.php?g=1265563, from which our guide is based and adapted.
Boston University recognizes the expertise and authorship of the ASU team.