FAQs for the NIH Policy for Data Management and Sharing (DMS Policy)

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The following FAQs are intended to help clarify implementation of the NIH Policy for Data Management and Sharing (DMS Policy) and will be updated on an ongoing basis

Policy Scope

The DMS Policy establishes the foundation for NIH’s data management and sharing expectations, which NIH ICOs and programs may build upon to meet their programmatic needs (e.g., designated repositories, specific data collection standards). Current NIH policies specific to certain types of research (e.g., clinical trials, research generating large-scale genomic data) continue to apply and complement the goals of the new DMS Policy. In the event that another applicable policy has more detailed expectations than that of the DMS Policy, those expectations should be followed in addition to the DMS Policy. Researchers and award recipients are advised to consult with the funding NIH ICO on how to comply with all applicable data sharing policies potentially affecting their NIH-supported research project.

Award recipients are responsible for ensuring that any research partnerships allow for compliance with the DMS Policy. Data sharing expectations should be established prior to the initiation of a partnership, whenever feasible, and any limitations to sharing should be described in Plans. Researchers and award recipients are advised to consult with the funding NIH ICO on how to comply with all applicable data sharing policies potentially affecting their NIH-supported research project.

No. Projects that only develop or support infrastructure resources (e.g., repository or knowledgebase establishment) and do not generate findings or scientific data are not subject to the DMS Policy. However, NIH recommends that the infrastructure developed with NIH resources comport with the desired characteristics for repositories (see “Selecting a Repository for Data Resulting from NIH-Supported Research”).

Managing and Sharing Scientific Data

Scientific data should be made accessible as soon as possible, and no later than the time of an associated publication or the end of the performance period of the extramural award that generated the data. If a no cost extension is granted for an extramural award, scientific data should be made accessible no later than the time of an associated publication, or the end of the no cost extension, whichever comes first.

NIH expects that in drafting their Plans, researchers will attempt to maximize scientific data sharing, but may acknowledge that certain factors (i.e., ethical, legal, or technical) may necessitate limiting sharing to some extent. Foreseeable limitations should be described when drafting DMS Plans. Per the supplemental information “Elements of an NIH Data Management Sharing Plan,” a compelling rationale for limiting scientific data sharing should be provided and will be assessed by NIH. Potential examples of justifiable factors include:

  • informed consent will not permit or will limit the scope or extent of sharing and future research use
  • existing consent (e.g., for previously collected biospecimens) prohibits sharing or limits the scope or extent of sharing and future research use
  • privacy or safety of research participants would be compromised or place them at greater risk of re-identification or suffering harm, and protective measures such as de-identification and Certificates of Confidentiality would be insufficient
  • explicit federal, state, local, or Tribal law, regulation, or policy prohibits disclosure
  • datasets cannot practically be digitized with reasonable efforts

Examples of reasons that would generally not be justifiable factors limiting scientific data sharing include:

  • data are considered to be too small
  • data that researchers anticipate will not be widely used
  • data are not thought to have a suitable repository

NIH respects and recognizes Tribal sovereignty and American Indian and Alaska Native (AI/AN) communities’ data sharing concerns, and NIH has proposed additional considerations when working with Tribes and AI/AN communities.

Under the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive, SBIR and STTR awardees may withhold applicable data for 20 years after the award date, as stipulated in the specific SBIR/STTR funding agreement and consistent with achieving program goals.

Considerations for Scientific Data Derived from Human Participants

Award recipients must comply with any applicable laws, regulations, statutes, guidance, or institutional policies related to research with human participants and that protect participants’ privacy. The DMS Policy encourages respect for participants by encouraging researchers and award recipients to:

  • Address data management and sharing plans during the informed consent process to ensure prospective participants understand how their data will be managed and shared;
  • Outline steps they will take for protecting the privacy, rights, and confidentiality of prospective participants (i.e., through de-identification, Certificates of Confidentiality, and other protective measures);
  • Assess limitations on subsequent use of data and communicate these limitations to the individuals or entities (e.g., repositories) preserving and sharing the data; and
  • Consider whether access to shared scientific data derived from humans should be controlled, even if de-identified and lacking explicit limitations on subsequent use. Sharing via controlled access may be specified by certain funding opportunity announcements (FOAs) or the funding NIH ICO(s).

No. Although the DMS Policy strongly encourages researchers to plan for how data management and sharing will be addressed in the informed consent process and to maximize the appropriate sharing of scientific data when developing Plans, the DMS Policy does not expect that informed consent given by participants will be obtained in any particular way, such as through consent for broad data sharing (e.g., the broad consent provision of the Common Rule at 45.CFR.46.116(d)). However, researchers should be aware that they may be subject to other requirements or particular expectations for consent, such as the NIH Genomic Data Sharing Policy. NIH is currently developing resources to assist in drafting consent language for the sharing of research participants’ data, please see Request for Information: Developing Consent Language for Future Use of Data and Biospecimens.

Compliance and Enforcement

NIH will monitor compliance with Plans over the course of the funding period during regular reporting intervals (e.g., at the time of annual Research Performance Progress Reports (RPPRs)). Noncompliance with Plans may result in the NIH ICO adding special Terms and Conditions of Award or terminating the award. If award recipients are not compliant with Plans at the end of the award, noncompliance may be factored into future funding decisions.