The NIH Office of Research Innovation, Validation, and Application (ORIVA) will coordinate NIH-wide efforts to develop, validate, and scale the use of human-based approaches across NIH biomedical research. ORIVA will serve as a hub for interagency coordination and regulatory translation for public health protection. 

New and emerging technologies have begun to allow researchers to study health and disease using human information, creating alternative methods to yield replicable, translatable, and efficient results either alone or in combination with animal models. 

These technologies include:

• Organoids, tissue chips, and other in vitro systems that allow scientists to model human disease and capture human variability and patient-specific characteristics.
• Computational models which simulate complex biological human systems, disease pathways, and drug interactions.
• Real-world data that allow scientists to study health outcomes in humans at community and population levels.

ORIVA will expand NIH funding and training in human-based approaches and increase awareness of their value in translational success. New funding opportunities will include evaluation criteria that assess methods based on their suitability for the research question, context of use, translatability, and human relevance. NIH infrastructure for human-based approaches will also be expanded to make these methods more accessible to researchers.

In addition, grant review staff is expected to participate in mitigation training to address any possible bias towards animal studies and integrate experts on alternative methods into study sections. NIH will also publicly report on research spending annually to measure progress toward reduction of funding for animal studies and an increase in funding for human-based approaches.

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