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

Key Dates

Release Date:

August 31, 2022

Related Announcements

NOT-OD-14-124 – NIH Genomic Data Sharing Policy

NOT-OD-19-023 – Update to NIH Management of Genomic Summary Results Access

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-22-189 – Implementation Details for the NIH Data Management and Sharing Policy

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

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

NIH continues to work with the biomedical research community to promote effective and responsible management and sharing of scientific data generated from NIH-funded or conducted research. In an effort to reduce the burden of duplicative reporting expectations, NIH is informing the research community of its intent to establish a single Plan submission requirement for research subject to both the NIH Genomic Data Sharing Policy (GDS Policy) and the NIH Policy for Data Management and Sharing (DMS Policy). This implementation update will take effect for Plan submission due dates on or after January 25, 2023.

Background

With public input, NIH has worked to develop and refine its DMS Policy, the goal of which is to increase the sharing of scientific data generated from NIH-funded research to ultimately enhance health, lengthen life, and reduce illness and disability. NIH heard clearly from stakeholders the importance of harmonizing data management and sharing expectations when possible to maximize efficient sharing and decrease administrative burden. Accordingly, in November 2021, NIH followed-up to request further public comment on its proposal to harmonize GDS Plan elements, submission, and review with the expectation for Plans submitted under the DMS Policy (NOT-OD-22-029).

Comments received were supportive of NIH efforts to harmonize plan submission expectations, including consolidating into a single data sharing plan submitted with the application. One comment suggested that the Institutional Certification also be submitted with the application rather than at Just-in-Time. However, Institutional Certifications will still be expected by Just-in-Time to ensure documentation only needs to be obtained for those proposals likely to be funded. The request for public comments also solicited input on changing the timing for submission of genomic data subject to the GDS Policy to the DMS Policy’s timing expectations of data availability (i.e., changing the GDS Policy’s expectation to match the DMS Policy’s expectation for sharing data no later than the time of publication or the end of the performance period, whichever comes first). Some comments indicated the potential for reducing burden, though others expressed concern that the DMS Policy timelines were unfamiliar to the genomics research community and could create compliance challenges while the GDS Policy timelines have a proven track record of success. NIH has decided not to change existing GDS Policy expectations for data submission timelines. Consequently, NIH is informing the research community that timelines for submission of both non-human and human data subject to the GDS Policy will remain unchanged after the DMS Policy goes into effect (see Data Submission and Release Expectations); however, in accordance with the DMS Policy, data will be expected to be shared no later than the end of the performance period (although in practice the GDS Policy will likely expect data to be shared earlier).

Applicability
Implementation changes outlined in this notice apply to all applications submitted to NIH requesting support for research subject to the GDS Policy (i.e., all NIH-funded research that generates large-scale human or non-human genomic data, or is subject due to programmatic priority, see NOT-OD-14-124), beginning with receipt dates on or after January 25, 2023.

Implementation Changes

Plans for sharing genomic data as expected by the GDS Policy are to be described in the DMS Plan submitted at the time of application, and not in a separate GDS Plan or at Just-in-Time, consistent with the changes described in NOT-OD-22-189. Therefore, after January 25, 2023, NIH will no longer be collecting separate GDS Plans. Genomic data sharing considerations, such as where and when genomic data will be shared, will be expected to be addressed in DMS Plans using the DMS Plan elements. For further details, see Writing a Data Management & Sharing Plan - Applications for Receipt Dates ON/AFTER Jan 25 2023.

Plan for Human Genomic Data Subject to the GDS Policy: For proposed studies of human genomic data subject to the GDS Policy, applicants should complete the DMS Plan anticipating sharing according to the criteria in the Institutional Certification. Institutional Certifications are expected for human genomic data subject to the GDS Policy (e.g., large-scale human genomic data) and/or Genomic Summary Results (GSR) (see NOT-OD-19-023) and may be submitted with the application, but will be requested at Just-in-Time prior to award. The Institutional Certification, or in some cases, a provisional certification, must be submitted and accepted before the award can be issued. See About Institutional Certifications for more information.

In cases where it is anticipated that Institutional Certification criteria cannot be met (i.e., data cannot be shared as expected by the GDS Policy), investigators should state this in their DMS Plan and indicate what data, if any, can be shared and how. In such cases, the DMS Plan and its elements will serve as the alternative data sharing plan as described in the GDS Policy. In some instances, the funding NIH Institute, Center, or Office (ICO) may need to determine whether to grant an exception to the data submission expectation under the GDS Policy. Studies provided exceptions to data submission under the GDS Policy will still be expected to be registered in the NIH Database of Genotypes and Phenotypes (dbGaP) for transparency.

Plan Designation for “Sensitive” Genomic Summary Results: Per NOT-OD-19-023, investigators conducting research subject to the GDS Policy should indicate in their DMS Plan if a study should be designated as “sensitive” for the purposes of access to GSR. In such cases, applicants should continue to indicate in the Institutional Certification if GSR are only to be made available through controlled access.

Assessment of Plans: As there will no longer be separate GDS Plans, but rather, a single data sharing plan for applicants subject to both the GDS and DMS Policies, GDS Plans will no longer be reviewed by peer reviewers (see NOT-OD-14-111). NIH Program Staff will assess the adequacy of DMS Plans. As described in NOT-OD-22-189, peer reviewers will not be asked to comment on the DMS Plan, nor will they factor the DMS Plan into the Overall Impact score.

Budget Request for Genomic Data Sharing Costs: This budget will include requested costs for genomic data management and sharing. As described in NOT-OD-22-189, 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. In accordance with the DMS Policy, peer reviewers will comment on the reasonableness of the budget for data management and sharing.

Compliance and Enforcement of the GDS Policy: Compliance and enforcement for awards subject to the GDS Policy will be handled in accordance with the compliance and enforcement terms in the DMS Policy as described in NOT-OD-21-013 Section VIII, which is not expected to result in any significant change in how noncompliance is enforced. As noted above for compliance regarding the timing of sharing data subject to the GDS Policy, NIH clarifies the addition of the “end of the performance period” as the latest opportunity to submit data in compliance with the data sharing plan.

Effective Date
Effective for NIH applications subject to the GDS Policy beginning with receipt dates on or after January 25, 2023.

Resources:

Inquiries

Please direct all inquiries to:

NIH Genomic Data Sharing Policy Implementation
Email: gds@mail.nih.gov