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.