The new administration’s policy shifts have once again sent ripples across multiple sectors, including clinical research. The National Institutes of Health (NIH), which funds a significant portion of medical research in the U.S., is experiencing changes due to executive orders, funding freezes, and budget restructuring. Researchers relying on NIH grants must navigate these new challenges to sustain their projects.
How Policy Shifts Are Affecting NIH Funding
Recent executive orders and funding directives have created uncertainty in the allocation of research grants. The most notable impacts include:
- Funding Pauses and Reviews – As of January 27, 2025, the new administration implemented a suspension of NIH grant funding, effectively freezing much of its $47 billion budget. Although legal challenges temporarily blocked this order, the administration exploited a loophole by withholding the publication of the agency’s meeting plans in the Federal Register, allowing the funding freeze to continue.
- Shifts in Research Priorities – The administration’s renewed focus on “America First” policies has redirected funding toward research with immediate economic benefits, such as drug manufacturing and biotechnology, rather than foundational or exploratory medical research.
- Regulatory Freezes and Compliance Reviews – A temporary freeze on regulatory approvals has been implemented, affecting NIH-funded projects. Researchers now face additional bureaucratic hurdles when seeking approvals for new studies or renewals of existing grants.
- Layoffs at NIH – Budget restructuring has led to staff reductions at NIH, impacting grant administration and the availability of expert reviewers. Approximately 1,000 to 1,200 NIH employees were terminated on February 15, 2025. This reduction may result in longer processing times for grant approvals and increased competition for remaining funding opportunities.
- Limits on Overhead Funding – The administration has reduced the allowable overhead funding from previously negotiated rates to a standardized 15%, significantly impacting institutions that rely on these funds to cover administrative and operational expenses. This drastic cut may lead to reduced research support services, higher out-of-pocket costs for institutions, and potential discontinuation of smaller or less commercially viable studies.
Importance of University-Based Clinical Research in the U.S.
University-based clinical research serves as the backbone of medical innovation in the United States. Academic institutions not only conduct foundational research that leads to groundbreaking treatments but also train the next generation of scientists and healthcare professionals. These universities often collaborate with hospitals and industry partners to translate laboratory discoveries into clinical applications, directly benefiting public health. Significant funding cuts and policy shifts threaten to disrupt this ecosystem, potentially hindering advancements in treating diseases such as Alzheimer’s, cancer, and heart disease.
What this Means for Public Health
The effects of these policy changes extend beyond research institutions, posing significant risks to public health. NIH-funded research plays a crucial role in advancing treatments, preventing disease outbreaks, and improving healthcare accessibility. If research funding remains uncertain, these vital initiatives may be delayed or halted, leading to widespread consequences.
Key concerns include:
- Slower Development of Life-Saving Treatments – Reduced funding can delay groundbreaking medical research, affecting the discovery of new treatments for diseases like cancer, Alzheimer’s, and rare genetic disorders.
- Increased Health Disparities – Cuts to research on underrepresented populations can widen existing health disparities, limiting progress in addressing public health issues affecting vulnerable communities.
- Weakened Pandemic Preparedness – Research on infectious diseases, vaccines, and public health responses may be deprioritized, leaving the country less prepared for future health crises.
- Limited Access to Cutting-Edge Therapies – Fewer clinical trials and medical advancements can restrict patient access to innovative treatments and personalized medicine options.
- Economic and Workforce Consequences – A decline in research funding could impact jobs within the biomedical and healthcare sectors, weakening the country’s position as a leader in medical innovation.
Implications for Clinical Researchers
The new policies pose several challenges for researchers seeking NIH funding. These include:
- Denials of Grant Applications – Grants that go against the current administration’s positions may find it difficult or impossible to secure funding, regardless of the professional opinion of research professionals.
- Delays in Grant Disbursements – The ongoing review process means that grants once approved may face delays or be subject to reevaluation.
- Increased Scrutiny of DEI Components – Researchers with projects focused on historically underrepresented populations may find it more difficult to secure funding due to shifts in policy priorities.
- Greater Emphasis on Commercial Viability – Studies that align with pharmaceutical development or immediate economic return may receive priority funding.
- More Bureaucratic Oversight – Regulatory freezes mean additional administrative steps before approvals are granted, slowing down research timelines.
- Institutional Financial Strain – The reduction in overhead funding may force institutions to reallocate internal resources, potentially reducing research support staff and infrastructure investments.
Expert Perspectives
Roxanne Alaniz, CEO of Alaniz Health, voiced her support for university researchers navigating these challenges, stating, “University-based research is the backbone of medical innovation in the U.S. While policy shifts create uncertainty, it’s more important than ever for researchers to stay resilient, seek strategic partnerships, and continue their vital work that benefits public health and scientific progress.”
“If these funding restrictions and administrative hurdles remain in place, we risk crippling the very institutions that drive groundbreaking medical discoveries. The U.S. university system is a cornerstone of clinical research, and limiting its ability to innovate could have long-term consequences for global healthcare advancements.”
Advice for Clinical Researchers
Given these challenges, researchers must adopt strategic approaches to securing funding and maintaining their studies. Key recommendations include:
- Stay Informed and Adaptable – Researchers should closely monitor NIH announcements and policy updates to proactively adjust their grant applications and research focuses.
- Align Research with Administration Priorities – Projects that emphasize economic impact, biotechnology advancements, or pandemic preparedness may have a higher chance of receiving funding.
- Lean Toward Inclusive Language – Leverage terms like “community health” and “community engagement” instead of DEI, diversity, or other highly politicized and targeted terms.
- Leverage Institutional Support – Universities and research institutions may offer bridge funding or administrative assistance to help navigate grant delays and reductions in overhead funding.
- Strengthen Industry Collaborations – Partnering with pharmaceutical companies and biotech firms can provide supplementary funding and resources.
- Diversify Funding Sources Where Possible – Relying solely on NIH funding may no longer be viable. Researchers should explore alternative funding from private foundations, industry partnerships, and international grants.
The new administration’s policy changes are reshaping the landscape of NIH funding for clinical research. By understanding these shifts and implementing adaptive strategies, researchers can better position themselves to continue their critical work in advancing medical science. The recent funding freeze and overhead cuts make it imperative for researchers to seek diversified funding sources and build industry collaborations. Researchers must stay vigilant, adaptable, and proactive in their approach.
