Office of Research Innovation, Validation, and Application

The mission of the Office of Research Innovation, Validation, and Application (ORIVA) is to coordinate NIH-wide efforts to accelerate the development, validation, and adoption of human-based methods(New Approach Methodologies, NAMs) in biomedical research, while advancing regulatory translation and ensuring public health protection. ORIVA brings together expertise from across NIH and federal partners to support cutting-edge research and infrastructure to achieve the following objectives:
1. Drive NIH-wide investment and innovation in human-based methodologies through the Division for Accelerating Innovation in Biomedical Research (DAIBR), overseeing new funding opportunities to support organoids, tissue chips, computational models, and real-world data approaches. Promote rigorous, human-based approaches and expand training to boost translational success.
2. Establish a central hub for validation and regulatory acceptance of NAMs through the Division of the National Interagency Center for the Evaluation of Alternative Test Methods (D-NICEATM), coordinate interagency efforts (NIH, FDA, EPA) to evaluate and validate NAMs for regulatory safety and biomedical research. Generate confidence frameworks, high-quality data, and scientific guidance to support regulatory uptake and reduce reliance on animal testing.
3. Enhance transparency, infrastructure, and review capacity for alternative methods by integrating NAM-specific criteria into grant funding and review processes, develop mitigation training to reduce animal-model bias, and publicly report annual spending shifts toward human-based methods. Invest in infrastructure to make advanced, human-based technologies widely accessible.

Applications are reviewed for scientific and technical merit by a scientific review group and for program relevance by a national advisory council/board. Grants and cooperative agreements are funded based on scientific merit, program relevance, and program balance and are made annually. The initial grant award provides funds for the first budget period (usually 12 months) and letter Notice of Award indicates support recommended for the remainder of the project period, allocation of Federal funds by budget categories and special conditions, if any. Other Transactions are awarded based on the criteria stated within the research opportunity announcement for each initiative.