NIH Data Management and Sharing (DMS)
The National Institutes of Health (NIH) has issued a new NIH Data Management & Sharing Policy which will go into effect for proposals for NIH funding that are submitted for due dates on or after January 25, 2023. The policy is intended to "promote the management and sharing of scientific data generated from NIH-funded or conducted research" in the interest in part of ensuring improved public access to publicly funded research and enabling data reuse for future studies.
In brief and relevant to proposals involving human research, researchers must include a data management and sharing plan in their proposals, and the plan must describe how IRBs as well as human subjects (study participants) will be provided with information about how such data may be shared and protected. See our NIH DMS requirements at-a-glance.
Click on one or more of the panels below to learn more and what to do if the NIH DMS Policy may apply to your human research!
- The NIH DMS Policy applies to applications (grants or contracts) for NIH funding and which applications involve research that may result in the generation of scientific data. Specific Funding Opportunity Announcements (FOAs) under which an application for funding will be or is submitted may have more specific NIH Institute or Center DMS stipulations or conditions. Review these FOAs carefully for any DMS provisions.
- The NIH DMS Policy will therefore require that FSU proposals for funding which may involve research through which scientific data will be generated, regardless of publication or dissemination, include in the proposal a data management and sharing plan within which core plan elements are described (e.g., protecting and maintaining scientific data; making scientific data available to others).
- Not all NIH funding may be subject to the NIH DMS Policy; to find out more, check this NIH link to see whether proposed research is subject to the DMS policy.
- See the NIH's 2023 DMS Policy Frequently Asked Questions.
The NIH DMS Policy requires, when the Policy is applicable, that FSU researchers develop a Plan for managing and sharing their scientific data; the DMS plan must be included as part of the NIH funding application. See our NIH DMS requirements at-a-glance.
Some high-level considerations:
- Review the NIH guidance for preparing your 2-page DMS Plan (generally, the plan should be included in the PHS 398 "Other Plan(s)" field)
- The Plan should address the recommended 6 core elements (on the page at the link, scroll down to "Elements to Include in a Data Management and Sharing Plan").
- The 6 core elements include: 1-data type; 2-related tools, software and/or code; 3-standards; 4-data preservation, access, and associated timelines; 5-access, distribution, or reuse considerations; and 6-oversight of data management and sharing (search the bookmarked elements here)
- A list and description of Plan elements is also provided in this NIH announcement
- At this NIH NIEHS link is an optional Plan format
- Plans should include designation of a suitable (e.g., "established") data repository (see FSU Libraries and Other Related Resources below)
- Special considerations may apply for specialized datasets, data privacy, and human subjects protections:
- Applications subject to both the DMS Policy and the Genomic Data Sharing (GDS) Policy will submit a single Plan. See NOT-OD-22-198 for details and other considerations.
- Provisions to secure and protect human subjects' data should be carefully noted and described in core element 5 ("access, distribution, or reuse considerations"), to include how shared human subjects' data may be protected, such as describing how human subjects will be informed about these protections through the informed consent process and consent materials; the implementation of suitable de-identification procedures; and use of the NIH Certificate of Confidentiality (CoC) [see our OHSP CoC link] to protect against compelled disclosure of human subjects' data.
- Notwithstanding any DMS plan submitted to NIH, an Institutional Review Board (IRB) may-in accordance with its authority under applicable federal law-restrict or prohibit the sharing of subjects' data, requiring your revision to any submitted plan; therefore, develop your plan carefully and accordingly.
- Note also that your Plan should, also in core element 5, describe whether there will be any restrictions on sharing, such as restrictions that result from regulatory requirements (e.g., the HIPAA "Privacy Rule", the EU General Data Protection Regulation or GDPR), Tribal laws, policies and Tribal sovereignty, and/or ethical considerations.
- Before you prepare and submit your DMS Plan, click on the "How to Inform Human Subjects about Your Data Management & Sharing" panel below to learn how to ensure that your plan is consistent with applicable FSU IRB requirements and templates.
- Compliance and Enforcement: Compliance with the DMS policy will be assessed by funding agency program staff; a Term and Condition of an award; and compliance will be reviewed and determined by the federal agency, Institute, Center or Office that may fund your study. Review will be conducted throughout the funding period. Additionally, after a project's funding period, compliance will be taken into consideration for any future FSU funding.
The NIH DMS policy requires that for NIH-funded human research from which scientific data will be shared, human subjects must be informed about how their scientific data may be used and shared; applicable federal law will also require that human subjects be adequately informed about such data use and sharing. Therefore, any protocol submitted for IRB review that includes research that may be or is funded by NIH, and to which the NIH DMS policy and data sharing applies, must include sufficient information about any plans for data management and sharing, including how human subjects will be informed. Additionally, the consent process and consent-related materials must include specific language about how the study team may use and share data. Both protocols and consents submitted for IRB review must be consistent with any submitted (if not yet NIH approved) or approved Data Management and Sharing Plan. An overview of our NIH DMS Policy-related protocol and consent requirements are provided below.
Protocol Requirements. In our template protocols (accessible in RAMP IRB under the Library and Templates tabs, scroll to HRP-503 and HRP-503a--each is tailored to biomedical/clincal studies and social/behavioral/educational research (SBER) respectively), refer to protocol template sections 7 (data banking, storage and sharing) and 17 (data management and confidentiality); instructions and links specific to the NIH DMS Policy are provided therein. Refer also to our Research Information Security page to see what should generally be included in FSU human research protocols regarding data management and confidentiality.
Consent Requirements. In our consent templates (also accessible in RAMP IRB under the Library and Templates tabs, scroll to HRP-502, HRP-502a, HRP-502b and HRP-502c--tailored for biomedical/clinical studies and SBER research as well as adult or subjects, as may be applicable), instructions and links specific to the NIH DMS Policy are provided, including for example in the HRP-502 section, "What happens to the information collected for the research?" or in the HRP-502a section "What will you do to protect my privacy?". Note that other requirements generally applicable to data sharing are also stipulated in our consent templates; refer to our Research Information Security page to see what else should be included in FSU human research protocols.
Office for Human Subjects Protection Resources
Below are provided some human research-related information and guidance to help ensure compliance with the NIH DMS Policy. Note that our IRB protocols and consent forms have been revised to include specific related instructions. Included below is our overview of the NIH DMS Policy and, if applicable to your research, some templated language for preparing your Data and Management Sharing Plan Element 5 (pertaining to Access, Distribution, or Reuse Considerations for human research informed consent, confidentiality and privacy). Note that the templated Element 5 language may also be used when preparing protocols and consent forms submitted for FSU IRB review.
- Refer to the panel above, "How to Inform Human Subjects about Your Data Management & Sharing", for how we provide new instructions in our protocol and consent templates for preparing your FSU IRB submissions
- OHSP's NIH DMS requirements at-a-glance (1-pager briefing)
- OHSP Overview of NIH DMS Policy [link to slides]
- Human Research Protections-Related Template Language for DMS Plans (Element 5) [RAMP IRB link or external link; or opens a Word document for ease of use)]
Florida State University Libraries Resources
The FSU Libraries provide a wide range of Research Data Management guidance, including guidance for planning and creating data management plans as well as suggested best practices, list of data repositories, agencies/sponsors' data sharing requirements, and sample data management plans. Researchers planning NIH funding applications are strongly advised to access these resources and to contact the FSU Libraries Research Data Management Librarian for further information and additional resources or support:
- FSU Libraries Data Management & Sharing Plans (slides include links to numerous resources; the recorded webinar is now available)
- FSU Libraries Research Data Management page
- FSU Libraries List of Data Repositories
General DMS Policy-related Resources
- NIH Application Instruction Updates-DMS Costs (NOT-OD-23-161) (DMS costs may now be listed in many cost categories)
- NIH Policy for Data Management and Sharing (NOT-OD-21-013) (includes link to related announcements)
- NIH Office of Extramural Research and Office of Science Policy-hosted webinars for understanding the new NIH DMS policy
- See the NIH's 2023 DMS Policy Frequently Asked Questions
- NIH Scientific Data FAQs
- NIH links for managing and sharing scientific data
- DHHS Secretary's Advisory Committee on Human Research Protections, Attachment A - NIH Data Sharing Policy Implications of the NIH Draft Policy for Data Management and Sharing on Data Derived from Human Participants (identifying challenges and providing guidance to the research community) [link]
- NEW! 12 tips and resources recently released by NIH, including a 1-pager on the who, what, where and when about the DMS policy; sample DMS plans; and a list of activities that may or may not generate scientific data for purposes of knowing when the DMS policy may apply
Preparing a DMS Plan
- Writing a Data Management & Sharing Plan (find out what NIH expects should be addressed in Data Management & Sharing Plans)
- NIH Supplemental Information: Elements of an NIH DMS Plan
- National Institute of Mental Health Data Sharing for Applicants and Awardees (link; includes links to sample DMS plans)
- DMPTool (University of California service for creating DMPs; easy sign up for accessing templates and tools)
- FASEB DataWorks! (Federation of American Societies for Experimental Biology page to learn about data management plans and receive expert feedback) [link]
Data Sharing Repositories
Gratitude and credit is extended to the NIH, FSU Libraries, OpenScience, UW, VCU and UC for some of the content and links used in this page.