Office of the Director

What this funds

The National Institutes of Health (NIH) Office of the Director (OD) is the central office that plans, manages, and coordinates all policies, programs, and activities at the agency. OD provides essential support to NIH Institutes and Centers (ICs) and leads NIH-wide cross-cutting initiatives and special programs to address the nation's most challenging health issues. The OD oversees program evaluation, and various offices that address specific areas like women's health research, nutrition research, and research infrastructure. Key programs led by OD that drive innovative science and affect system-wide change are summarized below. NIH launched the Autism Data Science Initiative (ADSI),1 a more than $50 million research effort designed to explore contributors to the causes and rising prevalence of autism spectrum disorder. Autism rates in the United States have increased dramatically from fewer than 1 in 2,000 children in the 1970s to approximately 1 in 31 today, yet the underlying causes remain complex and poorly understood.2 ADSI will fund 13 research projects that integrate large-scale datasets--including genomic, environmental, clinical, behavioral, and services data--using advanced analytical methods, machine learning, and exposome-wide analyses (the comprehensive study of environmental, medical, and lifestyle factors). Projects will investigate and genetic risk interact to contribute to autism. Independent replication and validation centers will help ensure findings are reproducible and useful for real-world application. Importantly, each research team will partner with the autism community, including autistic individuals, caregivers, and service providers, to ensure the research addresses their needs and incorporates NIH has also established the Standardized Organoid Modeling (SOM) Center,3 the nation's first dedicated facility for developing standardized organoid research protocols. Organoids are miniature, lab-grown tissue models that replicate human organ structure and function, offering alternatives to animal testing. However, current organoid production relies heavily on trial-and- error methods in individual labs, creating reproducibility challenges. With $87 million in funding for the first three years,4 the center will use artificial intelligence (AI), robotics, and a variety of human cell sources to create standardized, reproducible organoid models. The SOM Center will provide open access to protocols, data, and physical samples for researchers worldwide, while also working with regulators from the U.S. Food and Drug Administration (FDA) to develop models suitable for preclinical testing and drug development. Additionally, several ICs, in coordination with OD, have led the NIH-wide Researching COVID to Enhance Recovery (RECOVER)5 Initiative, a national research program to better understand, diagnose, prevent, and treat Long COVID. The RECOVER Initiative addresses the widespread and varied impacts of Long COVID through a national research network that includes clinical trials of potential treatments, observational cohort studies, in silico studies of electronic health records, and studies of the underlying pathobiology. RECOVER is designed to be patient-and community-centered where people affected by Long COVID come together with researchers to provide input and help shape the Initiative's study designs and communications. RECOVER's comprehensive research framework has provided the critical foundation for NIH has longstanding robust processes and policies to promote the highest standards of scientific integrity. NIH has developed a roadmap for the future to uphold its commitment to gold standard science and strengthen public trust. The plan, announced in 2025, is based on nine core tenets outlined in the Executive Order (EO) issued by the President on Restoring Gold Standard Science:6 reproducibility, transparency, communication of error and uncertainty, collaboration, skepticism of findings, falsifiability of hypotheses, unbiased peer review, acceptance of negative results, and absence of conflicts of interest. In order to maximize transparency, NIH moved forward the implementation date of its Public Access Policy.7 The new policy went into effect on July 1, 20258 and aims to accelerate free public access to research publications resulting from NIH funding. This ensures that patients, health care providers, researchers, and the general public can immediately access taxpayer- funded research findings. The Policy promotes transparency and trust in science while NIH is also simplifying its grant application and funding processes. To align with other federal agencies and reduce redundancy and burden on researchers, Grants.gov will be the sole source for NIH funding opportunities.9 Additionally, a new "Highlighted Topics" webpage is a central source for research areas of interest to ICs or OD offices. The overall number of highly specific funding opportunities will be reduced, and NIH will move toward more broad parent announcements and investigator-initiated applications. Lastly, all grants information from ICs In 2025, NIH implemented a new Intramural Academic Freedom policy focused on protecting scientific discourse, streamlining and harmonizing research communication procedures, reducing barriers to publication, and facilitating media engagement about research while maintaining Building on the nine core tenets, NIH has launched a new, agencywide initiative that places replication and reproducibility at the heart of goldstandard science. This effort will expand longstanding NIH policies on data sharing and rapid public access, fund independent replication studies, create incentives and competitions to reward rigorous research, and establish a central infrastructure to embed reproducibility practices throughout the biomedical research enterprise. Data is the foundation of scientific discovery and AI innovation. The President's AI Action Plan, HHS AI Strategy, and Congressional AI Roadmap have all emphasized high-quality, AI-ready data as essential to American leadership in biomedical research and technology. The NIH research community has long identified the challenge of sustaining critical data infrastructure over time. In response, NIH has developed frameworks for forecasting long-term costs and is now finalizing a comprehensive plan for managing Strategic Biomedical Data Assets (SBDAs). SBDAs are data resources, including real world data, that provide strategic utility for achieving NIH's mission to generate new understanding of living systems and advance health outcomes. These high-value assets drive the biomedical innovation engine that enables cutting-edge research. They are foundational to the NIH data ecosystem and America's competitive advantage NIH convened a working group to develop guidance on how to support, fund, and sustain SBDAs. The final recommendations will establish clear processes for: ' Identifying SBDAs among NIH's intramural and extramural data resources ' Ensuring stability and accessibility through robust governance and oversight ' Advancing FAIR principles (Findable, Accessible, Interoperable, Reusable) to maximize utility for AI and emerging technologies

Extracted from NIH - Office of the Director, p. 12. Verbatim; nothing here is paraphrased.

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