Writing a Data Management and Sharing Plan

Preparing a Data Management and Sharing Plan

Under the 2023 Data Management and Sharing (DMS) Policy, we expect researchers to maximize the appropriate sharing of scientific data, taking into account factors such as legal, ethical, or technical issues that may limit the extent of data sharing and preservation. If your application is subject to NIH’s Genomic Data Sharing (GDS) Policy, you must also address GDS-specific considerations within the DMS Plan.

Data Management and Sharing Plan Format

Prepare your DMS Plan using the required Data Management and Sharing Plan Format Page which includes the following elements 

1. Will there be maximum appropriate sharing of scientific data underlying peer-reviewed publications and other findings resulting from the work supported by this award (including preprints, referenced papers reported at conferences, and other findings)? [YES/NO]
2. Will the scientific data underlying peer-reviewed publications be shared by the time of publication or, for other findings, by the end of the period of performance, which includes no-cost extensions? [YES/NO]
3. Will shared scientific data be made available for at least as long as required by applicable data repository policies and/or journal policies? [YES/NO]

4. If you answered “no” to elements 1, 2, or 3, or if you anticipate that sharing will be limited in some other way, please describe these limitations and the ethical, legal, or technical factors for them. Your response should specify a particular reason(s) for limiting sharing. [300 words maximum]

   Tip

   Find examples of what may or may not be justifiable factors for limiting sharing at Maximum Appropriate Sharing of Scientific Data.
5. If scientific data derived from human research participants will be shared, will privacy, rights, and confidentiality of participants be protected as outlined in NOT-OD-22-213, including whether any scientific data will be shared using access controls? [YES/NO]
6. In table format, please list [100 words maximum]:

The table provided includes columns for expected data types and repositories.

1. Key types of scientific data anticipated to be generated during the project, including the species and modality, if known (e.g., “human genomic data,” “rat functional magnetic resonance imaging data”). NIH recognizes that not all data types expected to be generated in the study will meet the definition of scientific data or can be anticipated in advance.  If a data type does not appear on the list, it does not imply that that data type will not be shared if it is generated in the study.

   Tip

   Consult Data Submission and Release Expectations for information on the data types to be shared under the GDS Policy which may include data types not covered by the DMS Policy's definition of "scientific data".

2. The repository or an example of a repository where the scientific data may be managed and shared, if the scientific data is known at time of application. NIH expects the use of established repositories for preserving and sharing scientific data when they are available.

   Tip

   Consult Selecting a Data Repository for information on selecting an appropriate repository.
7. For studies subject to the NIH Genomic Data Sharing Policy (GDS) (e.g., using NIH funds to generate large-scale human genomic data):

1. Will you share all large-scale human genomic and associated data in a NIH-designated repository according to the accelerated timelines expected in the GDS Policy? If “no,” address in element 4. [YES/NO/Not Applicable]. If “no,” address in element 4.

   Tips

   • For human genomic data:
     • Consult Where to Submit Genomic Data for repositories acceptable under the Genomic Data Sharing Policy.
     • Consult NIH’s Data Submission and Release Expectations. Share human genomic data according to documented expectations or by the end of the performance period, whichever comes first.
   • For Non-human genomic data:
     • You may submit data to any widely used repository.
     • Share non-human genomic data as soon as possible, but no later than the time of an associated publication, or end of the performance period, whichever is first.

2. Do you anticipate that when sharing large-scale human genomic data that you will be able to meet the expectations of the Institutional Certification in the GDS Policy? [YES/NO/Not Applicable] If “no,” address in element 4.

   Tips

   • Consult Completing an Institutional Certification Form for different versions of certification forms for use basesd on source of NIH Funding, when samples were collected, and consent status for samples collected.
   • For data derived from de-identified samples collected AFTER the effective date, informed consent is required for research use and data sharing regardless of whether data meet definitions of de-identified under the Common Rule.

Maximum Appropriate Sharing of Scientific Data

We expect researchers to take steps to maximize scientific data sharing. We also understand that certain ethical, legal, or technical factors may necessitate limiting sharing to some extent. You should describe foreseeable limitations in the DMS Plan and provide a compelling rationale for limiting scientific data sharing.

Examples of justifiable factors for limiting scientific data sharing 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
• restrictions imposed by existing or anticipated agreements (e.g., with third party funders, with partners, with repositories, with Health Insurance Portability and Accountability Act (HIPAA) covered entities that provide Protected Health Information under a data use agreement, through licensing limitations attached to materials needed to conduct the research)
• 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

Submitting Data Management and Sharing Plans

The DMS Plan should be submitted as follows:

• Extramural (grants): as part of the competing grant application
  • 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. See below for details on developing and formatting Plans.
  • 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

Assessment of Data Management and Sharing Plans

NIH Institute or Center (IC) program staff assess DMS Plans to ensure plan elements are adequately addressed, including any justifications for limiting data sharing. Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.

Peer reviewers are not asked to comment on the DMS Plan and the plan is not factored into the Overall Impact score, unless sharing data is integral to the project design and specified in the funding opportunity (see NOT-OD-22-189).

For information about budget assessment by peer reviewers, see Budgeting for Data Management and Sharing.

Revising Data Management and Sharing Plans

Pre-Award Plan Revisions: If the DMS Plan provided in the application cannot be approved based on the information provided, applicants will be notified that additional information is needed. This will occur through the Just-in-Time (JIT) process. Applicants will be expected to communicate with their Program Officer and/or Grants Management Specialist to resolve any issues that prevent the funding IC from approving the DMS Plan. If needed, applicants should submit a revised DMS Plan. Refer to NIH Grants Policy Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.

Post-Award Plan Revisions: Although investigators submit plans before research begins, plans 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) or a more appropriate data repository becomes available. If any changes occur during the award or support period that affects how data is managed or shared, investigators should update the Plan to reflect the changes. It may be helpful to discuss potential changes with the Program Officer. In addition, the funding NIH ICO will need to approve the updated Plan. NIH staff will monitor compliance with approved DMS Plans during the annual RPPR process as well.

Additional Considerations

All ICs follow the same requirements for the data management and sharing plan. However, some funding opportunities or ICs have specific expectations regarding relevant standards and repository selection. Investigators are encouraged to reach out to program officers with questions about specific ICO requirements.

We do not include the DMS Plan in the assembled e-Application seen by peer reviewers. We store it as a separate “Data Management and Sharing (DMS) Plan” document in the grant folder. Authorized users can view the document via the Status Information screen in eRA Commons. Although maintained as a separate document, the applicant institution takes responsibility for the DMS Plan along with the rest of the application contents when submitting an application.