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Research Data Management

This guide will assist researchers in planning for the various stages of managing their research data and in preparing data management plans required with funding proposals.

NIH-GEN DMSP

If using the DMPTool to write your NIH Data Management and Sharing Plan, please select the NIH-Default DMSP template. The NIH-FDP Pilot Templates do not have WVU, or DMPTool guidance at this time. 

The 2023 NIH Data Management and Sharing Policy

Previously, the National Institutes of Health (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.

NIH LogoThe 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).

Data sharing is a priority across NIH. To this end, many institutes, centers, and research programs have instituted specific data sharing policies in addition to the trans-NIH policies.  These policies can be found at the link above. Note that individual funding opportunities may specify other requirements or expectations, so be sure to read all instructions carefully.

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.

In addition to this guide, the Research Operations Portal has a webpage with WVU specific guidance on the new NIH DMS Policy.

What do I need to submit?

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

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 write the plan itself, the NIH has provided a generic DMSP plan on DMPTool

Any costs related to complying with the policy must be paid 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. 

Data Sharing

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. 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 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.

When do I need to share my data?

You will need to share your data when you publish your work or at the end of your performance period, whichever comes first.

However, some ICOs have issued specific policies that require more frequent data deposits.  For example, the National Institute of Mental Health (NIMH) has mandated that data be deposited in the National Institute of Mental Health Data Archive (NDA) every 6 months during the performance period of your grant.

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.

Where do I share my data?

NIH recommends sharing datasets through established domain-specific repositories where possible, 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. The National Library of Medicine has a list of Generalist Repositories. The Network of the National Library of Medicine (NNLM) also has tool to a help locate NIH-supported repositories for sharing research data that includes a subset of the larger NIH list linked above and the generalist repositories list. 

Two other great resources are, re3data.org  which offers detailed information on over 2000 different repositories for research data and FAIRSharing is another useful tool for locating data repositories.

The Research Repository @WVU

The Research Repository @WVU is not suggested by the WVU Libraries for sharing data resulting from NIH, or other federally funded research. The Research Repository @WVU can only be used for data and/or documentation in limited situations.  Do NOT include the Research Repository @WVU in your DMSP unless you have contacted researchrepository@mail.wvu.edu and discussed whether the repository can accept your data.

Compliance

Data Management and Sharing Plan become part of the Terms and Conditions of your award. Revision to the DMSP require approval 

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.

What do I need to do?

  1. Determine whether the NIH policy applies to you. If you are unsure whether NIH's new policy will apply to your research, check NIH's page about Research Covered Under the Data Management & Sharing Policy. Remember, all NIH funded or partially funded research generating Scientific Data will be subject to this policy beginning on January 25, 2023.
  2. Figure out your personal timeline. If you have an active NIH award going up for renewal with receipt date of January 2023, or if you are planning to submit an NIH proposal this year, then developing a DMSP should be a high priority, especially if you are working with external collaborators as it may take time to set up appropriate data procedures/agreements. 
  3. Read through this website to familiarize yourself with the changes and with the policy itself (including the supplements)
  4. 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. 
  5. Assess your own project and data management practices relative to the policy, especially around documenting existing practices and developing new ones to address the increased emphasis on data sharing and administrative oversight.
  6. Review data services at WVU (Coming soon)

Revising Data Management and Sharing Plans

Pre-Award Plan Revisions: 

If the DMS Plan provided in the application cannot be approved based on the information provided, applicants will be notified that additional information is needed. This will occur through the Just-in-Time (JIT) process. Applicants will be expected to communicate with their Program Officer and/or Grants Management Specialist to resolve any issues that prevent the funding IC from approving the DMS Plan. If needed, applicants should submit a revised DMS Plan. Refer to NIH Grants Policy Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.

Post-Award Plan Revisions: 

Although investigators submit plans before research begins, plans may need to be updated or revised over the course of a project for a variety of reasons for example, if the type(s) of data generated change(s), a more appropriate data repository becomes available, or if the sharing timeline shifts. If any changes occur during the award or support period that affects how data is managed or shared, investigators should update the Plan to reflect the changes. It may be helpful to discuss potential changes with the Program Officer. In addition, the funding NIH ICO will need to approve the updated Plan. NIH staff will monitor compliance with approved DMS Plans during the annual RPPR process as well. For more details, please refer to NOT-OD-23-185: Prior Approval Requests for Revisions to an Approved Data Management and Sharing (DMS) Plan Must be Submitted Using the Prior Approval Module.