Data Management and Sharing Plan Expectations for NIGMS Grantees

Effective January 25, 2023, NIH implemented a new policy to promote the sharing of scientific data. Sharing scientific data accelerates biomedical research discovery, in part, by enabling validation of research results, providing accessibility to high-value datasets, and promoting data reuse for future research studies.

NIGMS believes that, in general, most of its grantees are already meeting the NIH policy requirements and submitting a DMS plan with a grant application will formalize what PIs already do and make explicit the expectations of their scientific community for sharing of data. Most plans are expected to be concise (no more than 2 pages) and in many cases, they could be much shorter (see examples below).

NIH has developed a website with details about the policy, guidance and implementation. Additionally, a Data Management and Sharing Plan Format Page is available from NIH. ​If you have questions, you can contact NIH DMS Policy Staff or your NIGMS PO.

NIGMS Data Management and Sharing Plan - Examples

Below are examples of data management and sharing plans for different types of awards that have generally been deemed acceptable by NIGMS.

Data used in publications will be deposited directly in PubMed Central and, when available, the publisher's repository as supplementary data at the time of publication. We will deposit any additional data and associated experimental information generated in the published studies in a public database identified in the associated publication (for example Dryad Digital Repository: datadryad.org). Any sequence data will be shared through the SRA data repository or similar repository. Raw sequence data will be findable and identifiable through accession numbers corresponding with the project, study, and experiment. All methods and codes used or created will be discoverable through GitHub or similar repository. There are no restrictions on subsequent access, distribution, or reuse of the scientific data from this project. The PI and institutional official in charge of overseeing compliance will ensure submission of data occurs in a manner compliant with this DMS plan.

Data used in publications produced by pilot projects will be deposited directly in PubMed Central and, when available, the publisher's repository as supplementary data at the time of publication. Though we cannot predict the specific types of data that will be generated by pilot projects, each project will deposit data and associated experimental information generated in the published studies in appropriate repositories that may include specific NIH-supported repositories (e.g., GEO), or generalist repositories (e.g., Dryad Digital Repository: datadryad.org) as well as other subject- or disease-specific repositories (e.g., NIDDK Central Repository). The DMS plan will be updated at the time of RPPR if needed. The PI and institutional official in charge of overseeing compliance will ensure submission of data occurs in a manner compliant with this DMS plan.

Proprietary data generated from this award will not be shared for 20 years. For data that is shareable, we intend to publish data generated in these studies in a peer reviewed journal. If the datasets exceed what can be submitted to the journal and/or PubMed Central, we will store data in Dataverse, or another similar repository. If use of an additional repository becomes necessary, the unique accession number will be referenced in the associated publication. We anticipate data becoming available no later than 12 months after the end of the project period and remaining available indefinitely. We do not foresee a need to restrict access and intend to share all applicable, non-proprietary published data. Oversight and execution of this plan will be managed by the PI.

Data used in publications will be deposited directly in PubMed Central and, when available, the publisher’s repository as supplementary data at the time of publication.

  • Additional data and associated experimental information generated in the published studies will be deposited in a public database identified in the associated publication (for example Dryad Digital Repository: datadryad.org).

Clinical data/clinical trial data will be shared for general research use, as allowed by the participant's informed consents and our Institutional Review Board (IRB) requirements.

  • Informed consent documents used for the proposed clinical research will include explicit language informing the participant or legally authorized representative of broad data sharing under controlled access with general research use restrictions.
  • Privacy and confidentiality protections consistent with applicable federal, tribal, state, and local laws, regulations, and policies will be followed.
  • Data will be deidentified by removing all HIPAA identifiers prior to sharing, and the study will be covered by a Certificate of Confidentiality from the NIH.
  • Certain data or materials with privacy implications may be transferred to other researchers as limited by the informed consent document, and institutional IRB policies.
  • Clinical data/clinical trial data will conform to industry standard formats to enable further analyses of this study.
  • Additional metadata, protocols, and code will be included at the time of data release in an appropriate repository.
  • For studies including a clinical trial, NIH clinical trials policies regarding clinical trial registration, results reporting, and informed consent posting will be followed.

The PI and institutional official in charge of overseeing compliance will ensure submission of data occurs in a manner compliant with this DMS plan.

  • Recruitment progress and final results will be documented at clinicaltrials.gov.
  • One IRB-approved version of a blank consent form used to enroll participants will be posted on a public federal website designated for this purpose (clinicaltrials.gov or regulations.gov) after recruitment closes.
  • Protocols, informed consent forms to participate in the trial and for biological sample collection, data dictionary, and code book will be shared with the data through the repositories.
  • After the study is complete and unblinded, the study team will submit all remaining scientific data to the appropriate data repositories and will update the RCT status to "complete" in clinicaltrials.gov.
  • According to the proposed project timeline, the release of the remaining scientific data will approximately coincide with the submission of final results to clinicaltrials.gov, as mandated by NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information and will occur by the end of award or publication, whichever comes sooner.

NIGMS Data Management and Sharing Plan FAQs

Applicants will be required to submit a short DMS plan that describes how their lab will manage and share scientific data. We expect that most NIGMS grantees will not have to change their data management and sharing practices significantly from what they have already been doing. For example, most biomedical research publishers have had data sharing requirements in place for some time and applicants are already complying with them.

In general, NIGMS expects that its grantees will make data underlying peer-reviewed publications findable and accessible (within the legal constraints of human subjects data privacy and consent). In some cases, grantees might generate valuable, high-quality data that will not be published in a timely manner or at all, and in such instances these data sets should also be made findable and accessible. Expectations for the sharing of proprietary data may depend on the funding mechanism or source. You should discuss issues with the sharing of proprietary data with a Program Officer, or in the case of an SBIR/STTR application, the NIH SEED Office.

In general, the repositories grantees are already using, e.g., to comply with journal data sharing policies, will also be appropriate for complying with the NIH DMS policy. In addition, NIH maintains a list of some possible repositories that may be useful. This list is not exhaustive and applicants should also consult NIH’s guidelines for selecting a data repository​.

We expect that most NIGMS grantees will not have to significantly change their data management and sharing practices and thus incur additional costs, if any, will be modest. If you feel that complying with NIGMS' expectations for meeting the DMS policy will require significant additional expenditures, you may request these funds in your grant application and explain the need in the Budget Justification section. However, we advise you to discuss your plan with your program officer prior to submitting your application to ensure that you understand the Institute'​s expectations.