Key Dates

Related Announcements

NOT-OD-25-019 - Notice of Correction to the Eligible Organizations Section of ORIP's PAR-24-265: Shared Instrumentation Grant (SIG) Program (S10 Clinical Trial Not Allowed).

RFA-MH-25-200 - Early Psychosis Intervention Network (EPINET): Learning Health Care Research to Improve Mental Health Services and Outcomes (P01 Clinical Trial Optional).

NOT-OD-23-161 - NIH Application Instruction Updates Data Management and Sharing (DMS) Costs

NOT-OD-23-053 - Reminder: NIH Policy for Data Management and Sharing effective on January 25, 2023.

NOT-OD-21-013- Final NIH Policy for Data Management and Sharing

NOT-OD-21-014 Supplemental Information to the NIH Policy for Data Management and Sharing: Elements of an NIH Data Management and Sharing Plan

NOT-OD-21-015 Supplemental Information to the NIH Policy for Data Management and Sharing: Allowable Costs for Data Management and Sharing

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

NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

The purpose of this notice is to inform the extramural research community of implementation details for the NIH Policy for Data Management and Sharing (DMS Policy) affecting grant and cooperative agreement applications submitted for receipt dates on or after January 25, 2023. The specific changes to competing grant and cooperative agreement application instructions clarified below will be implemented with application form packages identified with a Competition ID of FORMS-H and incorporated into the forthcoming FORMS-H application guides.

Although the DMS Policy will apply also to Research and Development (R&D) contracts, NIH intramural research projects, and other funding agreements (e.g., Other Transactions), the forms changes and other implementation details provided in this Notice apply only to NIH extramural grant and cooperative agreement activities. Details applicable to R&D contracts will be incorporated into the appropriate Requests for Proposals, and details applicable to Other Transactions will be incorporated into the appropriate Research Opportunity Announcement.

Effective Date

The below implementation details for the NIH DMS Policy are effective beginning with competing applications submitted for receipt dates on or after January 25, 2023.

Applicability

The DMS Policy applies to all NIH research, funded or conducted in whole or in part by NIH, that results in the generation of scientific data. The DMS Policy does not apply to research and other activities that do not generate scientific data, for example: research training, fellowships, infrastructure development, and non-research activities. See Research Covered Under the Data Management & Sharing Policy for more details.

Implementation Update

Beginning with receipt dates on or after January 25, 2023, competing applications submitted for activities subject to the DMS Policy will be required to submit a DMS Plan at the time of application for NIH grants or cooperative agreements. The following changes will be made to forms to accommodate the new DMS Plan:

• Data sharing plans and genomic data sharing plans will no longer be submitted to the Resource Sharing Plan(s) field.
• A new Other Plan(s) field will be added to the following FORMS-H forms to collect a single PDF attachment containing the Elements of a DMS Plan, with details on how to prepare this attachment incorporated into the NIH Application Form Instructions by Fall 2022:
  • PHS 398 Research Plan
  • PHS 398 Career Development Award Supplemental Form
• An optional Data Management and Sharing Plan format page will be provided to assist applicants with the preparation of this attachment. A preview version of this format page is available now. A final fillable version will be available by Fall 2022 and instructions will be incorporated into the NIH Application Form Instructions. Use of this format page is recommended, but DMS Plans generated using other approaches will be accepted.
• The requested direct costs to support the activities proposed in the DMS Plan must be indicated as Data Management and Sharing Costs as follows:
  • R&R Budget Form: single line item in section F. Other Direct Costs
  • PHS 398 Modular Budget Form: as text embedded within the Additional Narrative Justification
• A brief summary of the DMS Plan and a description of the requested Data Management and Sharing Costs must be included within the budget justification attachment, with details on what information to include incorporated into the NIH Application Form Instructions by Fall 2022; refer to NIH Grants Policy Statement Section 7.1 Cost Considerations for additional guidance on determining appropriate costs:
  • R&R Budget Form: embedded within the section L. Budget Justification attachment
  • PHS 398 Modular Budget Form: embedded within the Additional Narrative Justification
• These changes will be implemented with application form packages identified with a Competition ID of "FORMS-H" and associated application guide instructions. Additional details will be incorporated into the NIH Application Form Instructions by Fall 2022.

Assessment of the DMS Plan and Budget

Program staff at the proposed NIH Institute or Center will assess DMS Plans to ensure the Elements of a DMS Plan have been adequately addressed and to assess the reasonableness of those responses. Applications selected for funding will only be funded if the DMS Plan is complete and acceptable.

During peer review, reviewers will not be asked to comment on the DMS Plan nor will they factor the DMS Plan into the Overall Impact score, unless sharing data is integral to the project design and specified in the Funding Opportunity Announcement. On the proposed budget for data management and sharing, peer reviewers may provide comments on the reasonableness of the budget 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 DMS Plan attachment.

When Data Sharing is Integral to the Funding Opportunity Announcement

Program staff will assess the adequacy of the DMS Plan attachment for specific Funding Opportunity Announcements where data sharing is integral to the project design and tied to a scored review criterion. In these cases, peer reviewers will be able to view the DMS Plan attachment and may factor that information into the score as outlined in the evaluation criteria.

Processes for Plan Revisions Requested and Just-in-Time Submission Process

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 or Grants Management Specialist to resolve any issues that prevent the funding NIH Institute or Center from approving the DMS Plan, and potentially to submit a revised DMS Plan. Refer to NIH Grants Policy Statement Section 2.5.1 Just-in-Time Procedures for additional guidance.

Processes for Post-Award Plan Revisions and Submission Process

Following award, recipients are required to comply with the version of the DMS Plan that was approved by the funding NIH Institute or Center. DMS Plans may be updated during regular reporting intervals as part of the annual Research Performance Progress Report (RPPR) process. Refer to NIH Grants Policy Statement Section 8.4.1 Reporting for additional guidance. Changes to the DMS Plan must be approved by the funding NIH Institute or Center.

Inquiries

Please direct all inquiries to:

NIH Scientific Data Sharing Policy Implementation
Email: [email protected]