NIH Data Management and Sharing Policy (2023)

NIH Data Management and Sharing Policy (2023)

This developing resource is intended to inform the University of Florida (UF) community about the new National Institutes of Health (NIH) Data Management and Sharing Policy (DMSP) with links to relevant resources as available. This resource will be updated as new information becomes available.

What is new about the 2023 NIH Data Management and Sharing Policy?

The new NIH Data Management and Sharing Policy (DMSP) becomes effective January 25, 2023. An overarching goal of the NIH DMSP is a commitment to making the results of NIH-funded research available through responsible data management and sharing while accelerating biomedical research, enabling validation of research results, and providing accessibility to high-value datasets. The NIH DMSP includes three broad categories: 1. Planning & Budgeting for Data Management and Sharing, 2. Data Management, and 3. Sharing Scientific Data.

Effective January 25, 2023, ALL grant applications or renewals that generate Scientific Data must now include a robust and detailed plan for how you will manage and share 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.

What do you need to do?

A 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.”

What are the high-level first steps?

  1. Determine timeline. If you have an active NIH award going up for renewal after January 2023, then developing a DMSP is a high priority, especially if you are working with external collaborators in order to set up appropriate data management and sharing procedures/ agreements (e.g. data use agreements (DUA) – see: UF Office of Clinical Research (OCR) Data Use Agreements (DUA)).
  2. Read the Final NIH Policy for Data Management and Sharing policy (NOT-OD-21-013) (including the supplements)
  3. Familiarize yourself with the FAIR principles (Wilkinson et. al, 2016). The FAIR (findable, accessible, interoperable, reusable) data principles are the guiding principles the NIH has used in creating the new policy.
  4. Assess your own project and data management practices relative to the policy (see the NIH-provided supplements below), especially around documenting existing practices and developing new ones to address the increased emphasis on data sharing and administrative oversight.
  5. Review campus data services (e.g., computing, storage, consulting) and assess whether they will meet your needs. Also consider costs you may need to budget for such as labor for data cleaning and documentation (see the NIH-provided supplement on allowable costs).

If your research requires IRB approval, UF’s IRB may ask for information contained in your DMSP. Therefore, it is strongly recommended to draft your DMSP prior to seeking IRB approval. The new NIH DMSP (2023) template is available in the free data management planning tool, DMPTool, https://dmptool.org/.

What do you need to submit as a part of your funding proposal?

If you plan to generate scientific data, you must submit a Data Management and Sharing Plan 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 the following six components:

  1. Data Type (e.g. Library of Congress Recommended Formats Statements 2022-2023)
  2. Related Tools, Software and/or Code
  3. Standards (e.g. Seeing Standards: A Visualization of the Metadata Universe (Riley, 2010))
  4. Data Preservation, Access, and Associated Timelines
  5. Access, Distribution, or Reuse Considerations
  6. Oversight of Data Management and Sharing – The following language for element 6, Oversight of Data Management and Sharing, for adding to UF’s DMPTool developed by the Assistant Director for Strategic Research Development was approved by UF Office of Research on 2 Mar 2023.
    •  Senior/Key Personnel of the project will have primary oversight responsibility of maintaining compliance with data sharing and management for the project. The PI has the responsibility of guiding the day to day direction of the project, guiding the research efforts, ensuring the project stays on track and ensuring all reporting and procedures as outlined are met. The PI and Senior/Key Personnel will monitor the data management and sharing as needed in team meetings and at least monthly with the entire project team. The data management and sharing plan will be revisited annually to ensure all metrics and policies are followed. The PI will be responsible for communicating all changes with data management and sharing to the project team.

See: Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan  (NOT-OD-21-014) for a detailed description of these Elements. For additional resources, refer to Checklist for a Data Management Plan (v.4.0, 2013).

DMP examples by UF researchers: You can view select examples of data management plans by UF researchers from successful grant awards in the University of Florida Data Management (DMP) repository via https://zenodo.org/communities/uf_research-dmps/?page=1&size=20.

DMPToolTo draft the plan itself, we recommend the DMPTool (log in with Gatorlink credentials) using the NIH 2023 template. Additional guidance for completing each section of the template will be added to the DMPTool on a rolling basis.

 

Budget

Costs to execute the DMSP can be included in the budget as a line item and a brief summary of the DMSP must be provided in the budget justification. Allowable costs include labor for data curation, preservation, de-identification, and more. The NIH has a provided a list of allowable and unallowable 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) https://nda.nih.gov/nda/forms.html or the publication Forecasting Costs for Preserving, Archiving, and Promoting Access to Biomedical Data useful.

Some services provided by the University are free of charge while others are not. While free services do not need to be included in the budget, please consider contact the managing office prior to including them in your DMSP (e.g., repositories). See the following section for what kinds of services and tools are available to you.

Data Management and Sharing checklist

Download this DMS checklist to verify you have all the required elements. (Source: Ye, H., et al. (2022), https://doi.org/10.17605/OSF.IO/UADXR).

UF Research Data Management Sharing Plans & Repositories

Planning for a project involves making decisions about data resources and potential products. A data management sharing plan describes data that will be acquired or produced during research; how the data will be managed, described, and stored, what standards you will use, and how data will be handled and protected during and after the completion of the project. 

OSTP Issues Guidance to Make Federally Funded Research  Freely Available Without Delay (August 25, 2022)

“… In an memorandum to federal departments and agencies, Dr. Alondra Nelson, the head of OSTP, delivered guidance for agencies to update their public access policies soon as possible to make publications and research funded by taxpayers publicly accessible, without an embargo or cost. All agencies will fully implement updated policies, including ending the optional 12-month embargo, no later than December 31, 2025.” Read here.

See: UF Research Data Management Sharing Plans & Repositories – https://research.ufl.edu/education-and-training/data-management-sharing-plans-repositories.html.

Help

For assistance with your data management plans contact the Data Management Librarian.

For additional assistance please contact members of the Academic Research Consulting & Services (ARCS) for assistance via https://arcs.uflib.ufl.edu/consultations/. 

*Note: This resource was adapted from The University of Arizona NIH Data Management and Sharing Policy (2023), https://data.library.arizona.edu/data-management/nih-data-management-sharing-policy-2023.