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SHARE: NINDS Data Sharing: Information for Applicants and Awardees
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            What is the NIH Data Management and Sharing Policy and How Does it Relate to NINDS?

As highlighted in the 2021-2026 NINDS Strategic Plan and an NINDS Director’s message, NINDS is committed to promoting broad and appropriate sharing of scientific data to accelerate knowledge and application of research findings to enhance neurological health. Prospectively planning for how scientific data will be managed and shared is a crucial step in optimizing the impact of data generated from NIH-funded research.

Starting with applications received on/after January 25, 2023, investigators will be required to follow the NIH Data Management and Sharing Policy. Briefly, this policy applies to research funded in whole or in part by NIH that generates scientific data and requires:

Submission of a Data Management and Sharing Plan (DMSP) outlining how ***scientific data**** and any accompanying metadata will be managed and shared, taking into account any potential restrictions or limitations.
	Compliance with the DMSP as approved by NINDS staff for NINDS awards.****Scientific Data*** is 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. Genomic data that was previously included in a separate plan should now be included in this DMSP.

**Possible Exceptions to Data Sharing:** NIH expects that researchers will take steps to maximize scientific data sharing, but acknowledges that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. A compelling rationale for limiting scientific data sharing should be provided in the DMSP and will be assessed by NINDS.Please seeexamples of justifiable reasons for limiting sharing of dataandProtecting Privacy When Sharing Human Research Participant Data for more information.  You should plan for the maximal feasible/ethical data sharing of data, and be prepared to work withNINDSprogram staff further prior to award in situations specific to your application.

How do I Know if this Policy Applies to My Application or Grant?

This policy applies to many of the most commonly used grant mechanisms at NINDS including many R-, P-, and K- mechanisms and certain U (cooperative agreement) applications.

**There are two ways to check if this policy would apply to your NIH and NINDS funded work:**

Section IV of the NOFO you are intending to apply to will specify whether a DMSP is required, along with any additional instructions to those in the standard NIH instruction guide.
	Consult the “Applicable Activity Codes” (PDF, 252 kb) NIH page for those grant and other award mechanisms (also known as “activity codes”) where this policy applies.exclamation

Other Sharing Policies May Apply

There may be other sharing policies that apply to your work such as model organism, research resource/tool sharing, genomic data sharing, and/or clinical trial dissemination and reporting. This decision wizard can be helpful for determining which NIH policies may apply to your research.

What is Required in a DMSP and How Do I Submit?

If this policy applies to the NOFO and grant mechanism you are considering, you will need to prepare a DMSP and later comply with the approved DMSP. Note that the previous NIH Genomic Data Sharing policy (GDS) has been rolled into this policy, so content that you may have previously included as a separate GDS plan should be included in this DMSP starting with applications received on/after January 25, 2023.

You will need to cover six required elements in writing your DMSP.

NINDS strongly recommends use of the NIH-provided optional template form to assemble your DMSP

**Data Type**
	**Related Tools, Software and/or Code**
	**Data Standards**
	**Data Preservation, Access, and Associated Timeline**s (data should generally be shared as soon as possible, and no later than the time of publication or the end of the project period, whichever comes first. See additional resources for “When should scientific data be shared," considerations for data related to an invention / potential patent, and extensions for SBIR/STTR)
	**Access, Distribution, or Reuse Considerations** (including considerations for consent of human research participants and guidance on privacy considerations when working with human research participant data)
	**Oversight of Data Management and Sharing**The NIH Data Sharing site provides guidance on how to get started on writing a plan and budgeting for data management and sharing. It is critical to start with the information provided in these resources.

For some example plans, see the Sample Plans on the NIH Data Sharing site

Instructions for how to submit the plan can be found in the NIH application instruction guide starting with “Version H” (sometimes referred to as “FORMS H”).

How to Select the Most Appropriate Data Repository

Under the NIH Data Management & Sharing Policy, investigators are empowered to choose the most appropriate methods for sharing scientific data. The following NINDS guidance may be useful for developing a robust DMS plan for your research project.

NINDS envisions that a broad range of data types will be shared by NINDS-funded investigators, and that a broad range of related tools, software, and/or code will need to be shared as well to promote the sharing of this data following the FAIR principles of **F**indability, **A**ccessibility, **I**nteroperability, and **R**euse.

How to select the most appropriate data repository for your data****

How to select the most appropriate data repository may be one of the most challenging aspects of this policy for many. You may be generating several different data types or sets as a part of your proposed work. All of this data does not need to go into the same repository or place. Follow the steps outlined below to find the best fit for each data type/set you will be generating. Ultimately, consider the goals of this policy – to promote the use of NIH-supported data. Use that to guide you through this process and in regard to your particular situation.

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We're here to help!

Your NINDS Program Officer may be able to help with commonly used or recommended repositories in your field. Consider reaching out as part of your DMSP development process.

**First, consider whether your application includes the collection of data subject to the NIH Genomic Data sharing policy.** See NINDS-specific guidance for making this determination which is based on the species and scale of genomic data you are proposing to collect. If so, follow the instructions for incorporating your genomic data sharing plans into your overall DMSP.

**Second, determine if you are applying to a specific/targeted/solicited NOFO, and if so, whether that NOFO has any specific guidance as to requirements for data sharing.** You can find this information in “Section IV of the NOFO” typically under the “Other Plans” section, as well as likely in the “Section I. Funding Opportunity Description.”

Some examples of NINDS Sponsored and Partner Programs with Specified Data Sharing Requirements that will be included in the NOFO: 
	NINDS Clinical Research Networks
		NIH BRAIN Initiative Data Sharing Policies
		NIH HEAL Initiative Data Ecosystem
		NIH HEAL Data Sharing Policies
		NIH Rare Disease Consortium Data Sharing Policies
		FITBIR Policy for TBI Research**Third, if the NOFO you are applying to doesn’t have any specific data sharing guidance, does your data type or application goals fit one of the NINDS-supported open repositories or other NIH-recommended domain-specific repositories used widely in the field(s) you are working in?** If so, review repository requirements to determine if you would be able to deposit data there.



Examples of NIH and NINDS Supported Research Data and Biospecimen Repositories: 
	Federal Interagency Traumatic Brain Injury Research (FITBIR)
		NINDS Human Cell and Data Repository
		NINDS BioSEND
		NINDS Human Genetics Resource Center
		Database of Genotypes and Phenotypes (dbGaP)
		Parkinson's Disease Biomarkers Program (PDBP)
		NeuroBioBank
		More information about NINDS Cell/Tissue/DNA resources

**Fourth, explore options for community supported or endorsed repositories suitable for your research data types and access needs.** The Registry of Research Data Repositories (re3data.org) and fairsharing.org may aid in the identification of potentially suitable additional data repositories. Review possible matches for requirements for depositing data.

**Fifth, determine whether your institution has developed a repository that is suitable for your data types and application goals.** You may wish to consult your institution’s biomedical librarian as well for additional insight here. In anticipation of this policy, many institutions have developed specific resources to help comply with this policy.

**Finally, if you have exhausted all the options above, consider the NIH-recommended generalist repository** that best fits your data types and access needs.

NINDS Recommendations for Data Standards

The third element required in all DMSPs is a description of any data standards that will be used in your data set(s). NINDS strongly encourages the use of common data elements (CDEs) and other standards that promote the ready sharing, analysis, and re-analysis of data (interoperability and reusability). The following links provide additional information on specific NINDS-recommended common data elements and other NIH and HHS-funded data standards. Other non-NIH or US government-funded data standards may also be appropriate depending upon the field/discipline. Discussion with your Program Officer may be relevant regarding additional applicable data standards.

NINDS Common Data Elements
	NINDS Use of Global Unique Identifiers (GUIDs)
	PhenX Toolkit
	Neuropathology CDEs
	Office of the National Coordinator for Health Information Technology (ONC)
	cancer Data Standards Registry and Repository (caDSR)Budget Considerations

NIH and NINDS recognize that while many investigators have already been sharing data in similar ways to those described above, for some, compliance with this policy will come with additional work and potentially additional funding that can be requested as part of the competing application.

The NIH Budgeting for Data Management & Sharing page provides information and FAQs for:

What kinds of costs are allowable and unallowable
	How to request and justify costs for data management and sharing in your application
	And how these budget requests will be assessedHow will DMSPs be reviewed?

During peer review, reviewers will not have access or be asked to comment on the DMSP, nor will they factor the DMSP into the overall Impact score, unless sharing data is integral to the project design and specified in the Notice of Funding Opportunity.

Peer reviewers may provide comments on the reasonableness of the budget requested for implementing the DMSP, but these comments will not impact the score. *Peer reviewers will only use the information found in the budget justification* to determine whether the requested Data Management and Sharing Costs are reasonable, and will not be provided with the separate full DMSP.

Program staff at NINDS will assess DMSPs to ensure the Elements of a DMS Plan have been adequately addressed and to assess the reasonableness of the plan. Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.

Review by NINDS Staff Prior to Award

NINDS staff will review any budget comments from peer review
	NINDS staff will review the full DMSP including: 
	Ensuring that all relevant scientific data as defined above is covered within the plan
		Confirming that data sharing is maximized unless appropriately justified, will be shared in an appropriate repository, and within the timeframe defined by the policy
	Additional information may be requested by NINDS program staff during this review, and a revised/updated plan may be requested. Use standard JIT procedures to submit any updated/revised plans.

DMSP Reporting and Compliance Considerations

NINDS program staff will monitor compliance with approved DMSPs during the annual RPPR process. Further guidance on how/where to report this information in your RPPR is forthcoming.

What To Do if You Need to Change / Update your DMSP

Plans can and 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
	Any change to an approved Data Sharing and Management Plan as outlined in the terms & conditions in your notice of award requires ***prospective***prior approval (retrospective approval is not allowable)
	Prior approval requests *must be*submitted either in your RPPR or using the eRA Prior Approval Module as described in NOT-OD-23-185 if the request falls outside the RPPR submission timeline. Email and other communications are not acceptable.

Links to Additional Resources, FAQs, Training, Webinars, Etc.

DMS Policy Resources

NIH Scientific Data Sharing Homepage
	NINDS Interpretation of NIH GDS Policy
	NIH Office of Data Science Strategy (ODSS)Specific NINDS Program Data Sharing Policies

NINDS Clinical Research Networks
	NIH BRAIN Initiative Data Sharing Policies
	NIH HEAL Initiative Data Ecosystem
	NIH Rare Disease Consortium Data Sharing PoliciesNINDS-specific Data Standard Resources

NINDS Common Data Elements
	NINDS Use of Global Unique IdentifiersNINDS-Supported Data Repositories

Federal Interagency Traumatic Brain Injury Research (FITBIR)
	NINDS Human Cell and Data Repository
	NINDs BioSEND
	NINDS Human Genetics Resource Center
	Database of Genotypes and Phenotypes (dbGaP)
	Parkinson's Disease Biomarkers Program (PDBP)
	NeuroBioBank
	More information about NINDS Cell/Tissue/DNA resources
	Archived Clinical Research Datasets (for NINDS networks)Other Repository Options

NIH-supported Scientific Data Repositories
	Open NIH-supported Domain Specific Repositories (house data of a specific type or related to a specific discipline)
	Other NIH-supported domain-specific resources (including repositories and knowledgebases and may have limitations on submitting and/or accessing data)
	Registry of Research Data Repositories (re3data.org)
	Generalist RepositoriesTraining/Educational Resources

NIH Sharing Learning and Webinar Resources
	NIH ODSS Data Sharing and Reuse Seminar Series
	NIH ODSS Generalist Repository Ecosystem Initiative (GREI) Webinar SeriesFrequently Asked Questions

See a list of frequently asked questions on the 2023 NIH Data Management and Sharing Policy



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