The NIH Data Management and Sharing Policy, effective January 25, 2023, represents an evolution of longstanding efforts to advance data sharing in biomedical research. The policy mandates that all NIH-funded research submit a Data Management and Sharing (DMS) Plan and adhere to it, thereby formalizing expectations for responsible and maximized data sharing while allowing justified limitations for technical, legal, or ethical reasons. This initiative builds on prior policies and responds to the broader regulatory landscape shaped by the 21st Century Cures Act and recent federal directives. The overarching objective is to enhance study validation, stimulate new research inquiries, foster collaboration, and promote efficient stewardship of taxpayer-funded research through increased data accessibility and transparency.
Implementation of the policy involves rigorous planning, review, and compliance mechanisms, with requirements integrated into grant terms and monitored across project lifecycles. The NIH supports this transition by providing educational resources, supplementary guidance on budgeting for data management, and forums for stakeholder engagement. Efforts are underway to harmonize DMS expectations across institutes and other data sharing regimes, with continual assessment and refinement informed by community feedback and emerging needs. The NIH frames data stewardship as central to its mission of advancing scientific knowledge and accelerating the translation of research into practical benefits for patients and the public.
