The National Institutes of Health (NIH) recently released their final NIH Policy for Data Management and Sharing (DMS Policy) requiring the submission of Data Management and Sharing Plans and compliance with the approved Plans for NIH-funded or conducted research that results in the generation of scientific data. The policy will go into effect on January 25, 2023.
In his statement on the policy, the Director of the NIH, Francis S. Collins, M.D., Ph.D, said that the “extraordinary effort to speed the development of treatments and vaccines in response to the COVID-19 pandemic has put into sharp relief the need for the global science community to share scientific data openly.” “This policy also establishes the baseline expectation that data sharing is a fundamental component of the research process, which is in line with NIH’s longstanding commitment to making the research it funds available to the public,” he said.
What You Need to Know
Scope. The DMS Policy applies to all research funded or conducted in whole or in part by NIH that generates scientifica data. According to the NIH, scientific data are “the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings” regardless of whether they are used to support scholarly publications, and 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 specimens. This policy does NOT apply to research and other activities that do not generate scientific data such as training, infrastructure development, and non-research activities.
Definitions. Data management is the process of validating, organizing, protecting, maintaining, and processing scientific data to ensure the accessibility, reliability, and quality of the scientific data for its users. Data sharing is the act of making scientific data available for use by others. Metadata are data that provide additional information intended to make scientific data interpretable and reusable.
Requirements. The DMS Policy requires:
- Submission of a Data Management and Sharing Plan outlining how scientific data and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.
- Compliance with the awardee’s plan as approved by the NIH ICO.
Data Management and Sharing Plans
The NIH has developed guidelines that address recommended Plan elements in their supplemental Elements of an NIH Data Management and Sharing Plan document. These elements include:
- a description of the scientific data and metadata that will be managed, preserved, and shared,
- any tools, software/code necessary to access or manipulate data to support replication or reuse,
- standards that will be applied to the scientific data and metadata if available,
- plans and timelines for data preservation and access,
- factors affecting access, distribution, or reuse of scientific data,
- and how compliance of the Plan will be monitored and managed.
The Plans may be made publicly available and should not contain proprietary or private information. Costs associated with data management and data sharing may be allowable as part of the proposed project budget as outlined in the supplementary document Allowable Costs for Data Management and Sharing.
Managing and Sharing Scientific Data
In drafting Plans, it is expected that researchers will share scientific data to the fullest extent appropriate, acknowledging that legal, ethical, or technical factors may impose limitations. Research involving human participants and sharing/use of this data is governed by applicable federal, Tribal, state, and local laws, regulations, statutes, guidance, and institutional policies. Where there is an absence of written Tribal laws or policies, the DMS Policy clarifies NIH respect for Tribal sovereignty. You can find input from Tribal Nations as well as planned future researcher guidance in the NIH Tribal Consultation Report.
Researchers who propose to generate scientific data derived from human participants should outline in their Plans how privacy, rights, and confidentiality of said participants will be protected. It is strongly encouraged that researchers plan for how data management and sharing will be addressed in the informed consent process with prospective participants. Shared scientific data should be made accessible as soon as possible and either by the time of an associated publication or the end of the grant performance period, whichever comes first.
Data Repository Selection. The NIH encourages the use of established repositories for the preservation and sharing of data as this will generally improve the FAIRness (Findable, Accessible, Inter-operable, and Re-usable) of the data. The supplemental document on Selecting a Repository for Data Resulting from NIH-Supported Research provides guidance on when to use a designated repository, disciplinary or data-type specific repositories, what to do when neither applies depending on the size of your datasets, generalist repositories, as well as a list of desirable characteristics for all data repositories. The guidance also suggests reaching out to experts at your institution for help selecting among the different kinds of data repositories.
Compliance. Compliance with the Plan, including Plan updates will be assessed by the NIH ICO during regular reporting intervals. Non-compliance may result in enforcement action which can include additional special terms and conditions or termination of the award and could affect future funding decisions for the recipient institution.
How Research Data Services Can Help
As an interdisciplinary organization committed to advancing research data management and data sharing practices on the UW-Madison campus, we focus on providing researchers with the tools and resources that support their efforts to store, analyze and share data. You can reach out to us for help throughout the award cycle.
Pre-award. We are available to help you prepare your DMS Plan and can review it as many times as necessary prior to submission. UW-Madison is a member institution with DMPTool, which can be used to create your Plan. You can contact RDS consultants directly through the tool for support and schedule a consultation with us at any stage of your Plan writing process.
In the pre-award stage, RDS consultants can help you choose a repository that meets the characteristics set out by the NIH. Our forthcoming Storage Finder tool will also help researchers evaluate data storage and sharing options available through UW-Madison.
Post-award. When you are ready to share your data in compliance with your Plan, Research Data Services can help you prepare your data for sharing. We can help make sure that your description, metadata, and file formats all increase the FAIRness of your data.