NIH Data Management and Sharing (DMS) Policy FAQs

These FAQs do not replace NIH 2023 Data Management & Sharing Policy FAQs that address many practical DMS issues.

Scope and Policy

What data types are covered under the policy? What are some data type examples? In what format should scientific data be shared?
The DMS Policy defines scientific data 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.’ For NIDCR researchers, this might include, but is not limited to, the following data types: genomic and other ‘omic data; image data; de-identified clinical research or clinical trial results; static and dynamic biometric data; physical measurements or assays of bone, tissues; algorithms and computational programs; and questionnaire data, among others. ‘Data’ should also be considered to include appropriate metadata.

NIDCR expects that shared data be digital where applicable using standard file formats to facilitate data reuse, such as aligned sequences in a BAM file. Free text can be shared as is to maximally accommodate data reuse in research. Destination repositories may be able to provide additional guidance regarding standard file formats.

NIDCR expects data collection using Common Data Elements (CDEs), where applicable. When CDEs are used in a project, the DMS plan should indicate the intent to use the NIH CDE Repository and/or submit a CDE collection to the NIH CDE Governance Committee.

If data cannot be shared due to terms of consent or other ethical or legal reasons, the justification for the decision not to share should be clearly described in the plan so that the Program Staff can comprehensively evaluate the plan at time of award.

Does NIDCR require or recommend data be deposited to any specific repositories?
NIDCR applicants should start by referring to the list of repositories for sharing scientific data on the NIH Scientific Data Sharing site. If a funded project plans to deposit data into an institutional repository, its suitability can be informed by NOT-OD-21-016 Supplemental Information to the NIH Policy for Data Management and Sharing: Selecting a Repository for Data Resulting from NIH-Supported Research, which contains detailed guidance on important repository elements. Note, if the investigator has selected an atypical repository, additional justification may be required.

Will any research topics or data types be held to specific expectations?
No, all generated scientific data that meets the definition stated in the Policy is expected to be shared.

Will the expectations for NIDCR’s extension of the GDS Policy be retained? Are there unique expectations for genomic data?
Under the new DMS Policy all scientific data are expected to be shared, regardless of data type or sample size. NIDCR will retain the current extensions to the GDS policy to cover instances where genomic data might not reach the definition of ‘scientific data’ but is still expected to be shared under the GDS policy.

As described in NOT-OD-22-198, data that falls under the GDS Policy is expected to be shared according to timelines described in the GDS Policy, which for human data are accelerated compared to the DMS Policy. The use of the Institutional Certification to document data use limitations for data derived from human participants and samples will continue to apply.

When genomic data is shared in public repositories such as GEO, dbGaP, or FaceBase, data use limitations consistent with participant consent will apply. Sharing of phenotypic data associated with genomic data sets such as imaging, videos, biometric data, and metadata should be maximized and described in the DMS Plan.

The NIDCR Genomic Program Administrator (GPA) will continue to offer guidance and assistance on questions about this policy.

What products of secondary data analyses are expected to be shared? Does the original data set need to be shared?
See the policy and NIH FAQ.

How long should data be available?
The Policy states that researchers are encouraged to consider relevant requirements and expectations (e.g., data repository policies, award record retention requirements, journal policies) as guidance for the minimum time frame that scientific data should be made available, which researchers may extend. Researchers should consider any costs associated with data preservation in the development of the budget request submitted with their applications.

The human subjects protocol that will support the work proposed the grant will not be finalized until after an award is issued. How does a NIDCR approve a plan under these conditions?
At the time of submission, the Plan should describe the anticipated plans for sharing and can indicate dependence on approval bodies such as IRBs or availability of resources. The OSP document Informed Consent for Secondary Research with data and Biospecimens may be a useful resource for developing consent language with future use in mind. Plans may be revisited or revised prior to award and throughout the duration of the grant, with the approval of the Program Officer.

How will limitations on secondary use of human data be communicated?
The DMS Plan should state the consent-driven limitations of secondary use, whether the data should be under controlled access, and whether or not it is de-identified. Sharing between PI and repository will be dictated by Data Use Agreements, which don’t have to be delivered to NIDCR unless otherwise specified.

When individual-level data cannot be shared publicly, investigators should consider if/when summary data may be appropriate to share.

Do biospecimens fall under the scope of the policy?
Biospecimens are not in the scope of the DMSP, but PIs are encouraged to consider the long-term trajectory of research sharing and NIH investments when developing the resource sharing plan. Description of biospecimen sharing in the resource sharing plan that provides complementary information to the DMS plan is strongly encouraged. E.g., if extracted saliva DNA will be shared, then information about the saliva collection and DNA preparation kits/methods should be provided to guide the users on additional uses of the samples and reagents.

Award Management

What are the expectations for data generated for a project that spans two grant periods or that is pilot data for a larger project?
Per the policy, all grants that generate data that meets the definition in the Policy are expected to share applicable data by the end of the performance period. For guidance on renewals, see NIH FAQ B.4.

How will compliance with the policy be measured? Will non-compliance impact subsequent funding decisions?
Progress on compliance will be monitored yearly and in the Final RPPR submitted at the conclusion of the award period. If an active project is not in compliance with sharing expectations, the terms of award may be modified to allow enforcement.

Funding decisions on future applications take many factors into consideration and may include policy compliance.

Budget

What data management and sharing costs can be included in the budget? Are there NIDCR-specific limits for expectations on data management and sharing budget?
The funds needed to support data management and sharing will vary widely. Appropriate budget estimates will depend on data types, data volume, data complexity, and experience of the investigator team, among other factors. The Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing (NOT-OD-21-015) should be consulted for additional detailed guidance.

Will any research topics or grant types be eligible for supplementary support for data sharing?
NIDCR typically does not consider supplement applications to support data sharing on existing awards. New applications should carefully consider personnel and resource needs when developing a budget. Destination repositories may be able to provide guidance in budget development.

Need more information?

For general DMS policy questions, contact Sharing@nih.gov.

For scientific questions, contact the Program Director for your area of research.