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NIH Data Management and Sharing Policy 2023

Issued on October 29, 2020, the NIH Policy for Data Management and Sharing aims to promote the management and sharing of scientific data generated from NIH-funded or conducted research. The policy requires the submission of a Data Management and Sharing Plan, and expects that researchers will maximize the sharing of research data (with exceptions when justified). The policy will come into effect on January 25, 2023, and will cover grant applications for the January 25, 2023 cycle and all subsequent grant cycles.

The basics

All NIH supported research that results in the generation of scientific data is covered by this policy. For more information, see Research Covered Under the Data Management & Sharing Policy.
Unlike the previous NIH Data Sharing Policy, which only required a data sharing plan for grants seeking $500,000 or more in direct costs in a single year, all NIH supported research that generates data are required to submit a data management and sharing plan that explains how researchers will maximize data sharing. The elements of the new Data Management and Sharing Plan are described in depth in the Supplemental Policy Information: Elements of an NIH Data Management and Sharing Plan. The new policy also has more strict guidelines on the timeline of data sharing, and states that "data should be made accessible as soon as possible, and no later than the time of an associated publication, or the end of performance period, whichever comes first".
Scientific data in this policy is defined as "the recorded factual material commonly accepted in the scientific community as of sufficient quality to validate and replicate research findings, regardless of whether the data are used to support scholarly publications". It does not include laboratory notebooks, preliminary analyses, completed case report forms, drafts of scientific papers, plans for future research, peer reviews, communications with colleagues, or physical objects such as laboratory specimens.
As explained here, the Data Management and Sharing Plan will not affect the priority score of your application. Reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. Program staff will oversee the data sharing policy, and assess the appropriateness and adequacy of the plan, and if there are concerns, these will need to be resolved prior to making any award.
NIH has other sharing policies that may affect your research. In general, the 2023 NIH data policy sets the basic expectations, and other policies may add to these expectations. When two or more policies apply to a research project, the project should comply with all of them. In the case of the NIH’s Genomic Data Sharing (GDS) policy, relevant for research generating large-scale genomic data, NIH has generated guidance on how to comply with both policies.
In general, yes. The Data Management and Sharing Plan can be updated through the award, but these updates must be approved by NIH staff.
The policy says that "NIH expects that in drafting Plans, researchers will maximize the appropriate sharing of scientific data". The policy also acknowledges that there are legal, ethical, or technical factors that may limit data sharing. These factors should be discussed in the Data Management and Sharing Plan.

NIH Resources about the 2023 policy