NIH Data Policy
Under the new NIH Data Management and Sharing Policy, NIH-funded investigators and institutions are required to:
- Create and submit a data management and sharing plan outlining the data to be collected and how it will be stored and shared
- Comply with the approved plan during and after the grant period
- Follow any other relevant NIH Institute and Center Data Sharing Policies.
Why Is NIH Requiring Data Management and Sharing?
NIH, like many other research funders, has come to appreciate the benefits of data management and sharing to the research community. Enabling reuse of data already collected maximizes the impact of research funding, as well as supports research integrity.
How Will Complying with This Policy Help Me?
How to Comply with the Policy
Disclaimer: Advice in the DataWorks! Help Desk reflects interpretation of NIH policy and should be deemed as official perspectives of the agency. For official guidance, see the NIH Guide to Scientific Data Sharing.
Step 1: Familiarize Yourself with the Policy
Review the NIH guidelines on its Data Management and Sharing (DMS) Policy. Details and supplements provide further guidance on all of the steps below.
Step 2: Plan Your Research
- Some institutions have resources to support your planning efforts. Contact the research office, library, and/or IT department.
- Outline the scientific data you anticipate collecting as part of your research, e.g.,
- What types of information will be collected?
- What equipment, conditions, and file formats will be used?
- Are there any privacy or ethical issues involved?
- Consider how you will manage your data, e.g., consult the DataWorks! list of resources and the NIH Guide to Data Management.
- How and where will raw, analyzed, and/or generated data be stored during the research? How much space will be needed?
- What tasks will ensure your data are usable in the future and your research is reproducible?
- What file formats will be most usable?
- How will you describe your data (i.e., metadata) so that it can be readily understood by others and in the future?
- How will you organize your files (e.g., naming conventions)?
- What other tools and software will you use to organize your data (e.g., electronic lab notebooks)?
- Will data be collected or managed via services such as shared research facilities/cores?
- Who on the research team will be responsible for all these tasks?
- Outline how your data will be stored and/or shared after project completion.
- Consult the DataWorks! list of resources and the NIH Guide to Data Management.
- Assess how long you will need to store the data. Review your institution's policies and procedures for long-term data storage and retention of research records.
- Consider what data should be shared and how. Plan to deposit the final versions of your data in a trustworthy data repository, which can make your research findable, citable, and sharable in the long term.
- Check if the journal in which you hope to publish has data sharing or reporting requirements.
Step 3: Budget for Data Management and Sharing
Data management activities are integral to the research process; they require appropriate resources for which expenditures must be planned and included as part of the project budget. Resources available to help you estimate costs include:
- Consulting the latest version of the NIH Guide to Budgeting for Data Management and Sharing and this presentation on budgeting from the December Data Salon
- Reviewing supplemental community tools for estimating costs (while often originally developed for specific disciplines or institutions, they contain universal principles valuable to any research project):
Step 4: Write Your Data Management and Sharing Plan
- Use our guide to Writing an NIH DMP
- Draft a DMP, outlining the data you will collect and how they will be managed and shared according to the NIH DMP guidelines
- Create your plan easily with DMPTool. It is designed to walk you through the process. Create a new plan electing the NIH-GEN DMSP (Forthcoming 2023) template (which you can download in Word or PDF to prepare your responses). Additionally, researchers from participating institutions can access the system with their institutional login to easily fill out a DMP with context-specific institutional information
- Connect with local services to help create and implement a DMP
- Alternatively, use resources listed on the NIH Guide to Writing a Data Management Plan, such as NIH’s own draft template
- Contact key staff at your institution (e.g., your research team, research office or grant administrator, IT, and/or library) for information on local data management practices, as well as to see if they can advise you on creating and optimizing your plan.
Step 5: Submit Your DMP and Budget
- Include your DMP and associated budget request in your grant application
- Respond to requests from NIH for further information or pre-award revisions as needed
Step 6: Implement Your Plan
- Educate and gain support from all research team members and collaborators to follow the plan. Reiterate the consequences of noncompliance. Regularly check-in with team members (e.g., at lab meetings) to ensure they are keeping up the planned tasks.
- Manage and share your data per the details in your approved plan. Consult your institutional resources and the DataWorks! Help Desk for ongoing advice.
- As you work through the publishing process, check and follow your journal’s data sharing or reporting requirements (including regarding the timing of data sharing).
- Provide updates to NIH in progress reports.
- As your research evolves, you may change the type of data collected and/or how it is managed. If so, update your DMP, both for your own use and to keep up to date with NIH.
FAQ
The policy applies to most new applications received by NIH on or after January 25, 2023.
The NIH Data Management and Sharing Policy applies to all NIH-funded research that generates scientific data. This includes extramural grants, extramural contracts, intramural research projects, and other funding agreements. The DMS policy does not apply to projects that do not generate scientific data such as training, fellowships, conference grants, or research-related infrastructure programs.
For more information, visit the NIH guidelines on Research Covered by the 2023 Data Management & Sharing Policy, where you can use a decision tool to identify which policies apply to your research. You can also review this list of applicable activity codes to verify if the policy requirements apply to your grant.
For more information, visit the NIH guidelines on Research Covered by the 2023 Data Management & Sharing Policy, where you can use a decision tool to identify which policies apply to your research. You can also review this list of applicable activity codes to verify if the policy requirements apply to your grant.
The NIH DMS policy applies all scientific data that are collected during the grant period. According to the NIH guidelines on Research Covered by the 2023 Data Management & Sharing Policy, scientific data “is defined as data 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.” The policy does not cover related research materials, such as laboratory notebooks, preliminary analysis, drafts of scientific papers, peer reviews, communications with colleagues, or physical objects such as laboratory specimens.
According to NIH guidance, the DMP should be submitted as follows:
- For Extramural (grants)
- DMS plans should be included within the “Other Plan(s)” field on the PHS 398 Research Plan or PHS 398 Career Development Award Supplemental Form as indicated in the Application Instructions.
- A brief summary and associated costs should be submitted as part of the budget and budget justification (see Budgeting for Data Management and Sharing and the Application Instructions for details).
- Extramural (contracts): as part of the technical evaluation
- Intramural: determined by the Intramural Research Program
- Other funding agreements: prior to the release of funds
According to NIH's FAQ, “Noncompliance with Plans may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award…[and] may be factored into future funding decisions.” In general, generating and implementing a robust data management and sharing plan can boost your credibility with a range of stakeholders (including team members, collaborators, your institution, grant reviewers, and current and future funders).
Genomic researchers will be able to create a unified DMP for both requirements. According to this NIH notice, “NIH will no longer be collecting separate GDS Plans. Genomic data sharing considerations, such as where and when genomic data will be shared, will be expected to be addressed in DMS Plans.” See also the NHGRI Data Sharing Policies and Expectations.
Consult your specific NIH Institute and Center Data Sharing Policy. Additionally, research involving model organisms, research tools, or clinical trials may be subject to other NIH sharing policies. Use NIH's decision tool to identify which policies apply to your research.
Your DMP will need to describe how human subjects and/or sensitive data will be collected, managed, and shared. Factors to consider include informed consent (e.g., impact on downstream data sharing), secure storage and transfer, de-identification, and long-term access (e.g., via controlled access data sharing). For further guidance on managing human subjects data, consult:
- The DataWorks! guidance on managing data during and after your research
- Your Institutional Review Board (IRB)
- If working with genomic data, see the NIH Genomic Data Sharing Policy and guide to Using Genomic Data Responsibly.
Research often is collaborative and involves another funding agency in addition to NIH. Researchers must meet the requirements of all funders, including their respective data management policies. If it is unclear how to harmoniously comply with all policies, or for any further details, contact your program officers.
Some researchers get stuck because they worry their DMP must be “perfect.” In creating your DMP, keep in mind the spirit of such funder policies:
- Think and plan deliberately for how you will manage your data throughout your research, including for your own benefit. Ask questions such as:
- How can I make it easier for lab mates (future students and colleagues) to find and reuse the scientific data our group collects, generates, and/or analyzes?
- What if others needed to replicate the research experiment?
- Consider what data you collect could be useful to the broader community, and how to make it broadly usable and accessible.
Some research institutions may have staff with expertise to help you to understand and comply with the NIH policy in your local context. To explore local services, contact your library, research office/grant administrator, and/or IT/research computing.
NIH has a planned assessment process for all DMPs. Reviews will be conducted by Institute or Center Program Officers. Peer reviewers may comment on the proposed budget, but the DMP will not be a scored element of peer review.
One way you can prepare for the assessment process is to review the quality of your plan for your own use. Review our free Evaluation Rubric for the DataWorks! DMP Challenge to assist your preparation.
One way you can prepare for the assessment process is to review the quality of your plan for your own use. Review our free Evaluation Rubric for the DataWorks! DMP Challenge to assist your preparation.
Many funders such as National Science Foundation and many others, already have similar policies for data management and sharing. To find out the range of policies, consult the DMPTool catalogue of funder requirements.
NIH-funded research may be collaborative and involve another funding agency. In this case, researchers must meet the requirements of all funders, including their respective data management policies. If it is unclear how to harmoniously comply with all policies, or for any further details, contact your program officers.
NIH-funded research may be collaborative and involve another funding agency. In this case, researchers must meet the requirements of all funders, including their respective data management policies. If it is unclear how to harmoniously comply with all policies, or for any further details, contact your program officers.
For storage, processing, and analysis during your research project, consult your institution’s IT, research computing, and/or shared core resource facility to understand your options.
For long-term storage after the end of a research project, a range of data repository options are available (which can not only store your data long-term but also increase the prominence of your research).
For long-term storage after the end of a research project, a range of data repository options are available (which can not only store your data long-term but also increase the prominence of your research).
We have three tips to help. Make sure you:
- Comply with the NIH Policy, start your data management plan using DMPTool.
- Take advantage of local services at your institution. Contact your library, research office, and/or IT department to see what they might be able to offer.
- Leverage resources tailored to your discipline. As we build out the DataWorks! Help Desk, we will provide further detailed resources for biology and biomedicine.
NIH does not prescribe who should be responsible for oversight of the DMP. Investigators should consider and arrange with their team how best to integrate data management practices into their research process.
The American Association of Immunologists (AAI) has created a specialized guide to Resources and Recommendations for the NIH Policy.
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