As the Trump administration continues to make major cuts to the NIH budget and staff and freezes billions of dollars to major research universities (citing ideological issues) - it's not just advances in science and medicine, but threats. The valuable but often overlooked thing has also taken a major blow: preventing research abuse.
The National Institutes of Health has been the world's largest public funder for biomedical research. Its support helps translate basic science into biomedical therapies and technologies, funding nearly all treatments approved by the Food and Drug Administration from 2010 to 2019. This allows the United States to lead global research while maintaining transparency and preventing research misconduct.
Although the legality of the directive is not yet clear, the Trump administration's actions have led to clinical trials, institutions hiring freezes and layoffs, revoking graduate admissions and canceling federal grant review meetings. Funding will delay or possibly eliminate ongoing research on key conditions such as cancer and Alzheimer's, researchers at affected universities say.
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It is clear to us that because research in law and bioethics often focuses on the moral, legal and social implications of emerging biotechnology, these directives will have profound negative effects on medical research and human health, with a ripple effect that lasts for decades. Our scholarships show that in order to contribute to knowledge and ultimately to biomedical therapy, medical research at each stage depends on important infrastructure support and ethical supervision.
Our recent focus on brain organ research – from 3D laboratory models that simulate brain structure and function – shows how federal support for research can not only promote innovation, but also be key to protecting participants and future patients.
NIH and the History of Research Ethics
The National Institutes of Health began in 1887 in a single-room laboratory within the Marine Hospital Services Department. After World War I, chemists involved in war efforts tried to apply their knowledge to medicine. They worked with Louisiana Senator Joseph E. Ransdell, who was motivated by the disasters of malaria, yellow fever and the 1928 flu pandemic, proposed federal legislation to support basic research and funding scholarships, focusing on addressing medical problems.
In World War II, advances in biomedical science such as surgical techniques and antibiotics were crucial on the battlefield. Survival rates increased from 4% during World War I to 50% during World War II. Congress passed the Public Health Services Act of 1944 to expand the power of the NIH to fund biomedical research in public and private institutions. Franklin D.
With the development of science, the same is true for guardrails. After World War II, the Nazi supreme leader was prosecuted for war crimes by doctors who conducted experiments on unconsensual people, such as exposure to hypothermia and infectious diseases. The judgments of these doctors’ trials include 10 points on moral human research that became the Nuremberg Code, which emphasizes voluntary consent participation, social interests as the goal of human research, and significant restrictions on the permissible risk of harm. The World Medical Association developed additional international guidelines for physicians and researchers in the 1964 Declaration of Helsinki.
In the 1970s, information about Tuskegee research - a 40-year study of deceptive and immorality in black people's untreated syphilis. The researchers told the study participants that they would receive treatment but were not given medication. They also prevent participants from obtaining treatments when available so that they can study the disease as they progress. The men who participated in the study encountered major health problems, including blindness, mental disorders, and death.
Public outrage that followed showed that the United States cannot rely solely on international norms but requires federal standards for studying ethics. As a result, the National Research Act of 1974 led to the Belmont Report, which identified the essential moral principles of human research: respect for people, welfare and justice.
Federal regulations reinforce these principles by requiring all federally funded research to comply with strict ethical standards of human research. By prohibiting financial conflicts and implementing independent ethical review procedures, the new policy helps ensure federally supported research has scientific and social value, scientifically effective, reasonable choices and adequate protection of participants.
These standards and recommendations guide federal and non-government-funded research today. The breadth of NIH’s mandate and budget provides not only the basic structure of research oversight, but also a key resource for ethical consultation and advice.
Brain organs and the need for moral inquiry
Biomedical research on cellular and animal models requires extensive ethical supervision systems to complement the systems of human research. Our research on ethical and policy issues in human brain organ research provides a great example of the complexity of biomedical research and the infrastructure and supervision mechanisms needed to support it.
Organ studies are becoming increasingly important because the FDA wants to expand its use to replace animals testing new drugs before they are administered to humans. Because these models can simulate the structure and function of the brain, research on brain organs is an integral part of developing and testing potential treatments for brain diseases and diseases such as Alzheimer's, Parkinson's, and cancer. Brain organs can also be used in personalized and regenerative medicine, artificial intelligence, brain computer interfaces and other biotechnology.
Brain organs are based on basic knowledge about biology, which was developed primarily in universities that received federal funding. Organ technology began in 1907, and research on sponge cells was studied, and progress in stem cell research continued in the 1980s. The field has expanded rapidly since the researchers produced the first human organ in 2009.
These advances can only be achieved through federally supported research infrastructure, which helps ensure the quality of all biomedical research. Indirect costs cover the operating expenses necessary to maintain research safety and ethics, including utilities, administrative support, biohazard handling and regulatory compliance. In these ways, federally supported research infrastructure can protect and promote the scientific and ethical value of biotechnology, such as biotechnology.
Brain organ research requires a lot of scientific and moral inquiry to safely realize its future potential. It raises potential moral and legal issues regarding the extent to which donors agree, organs should be planted and how they should be addressed, as well as consciousness and personality. As science develops, oversight infrastructure can help ensure that these ethical and social problems are addressed.
New field of scientific research
The bipartisan support for scientific innovation since World War II is partly due to the necessity of economic and national security. As Harvard President Alan Garber recently wrote: “(n)EW borders recruit us the prospect of life-changing progress. … The government retreats from these partnerships now, now, not only risk the health and well-being of millions of individuals.”
Cutting down on research overhead costs seems easy to save, but it cannot explain the infrastructure that provides basic support for scientific innovation. NIH’s investment in academic research is significant, adding nearly $95 billion to local economies in the fiscal year 2024, with $2.46 per dollar of grant funds per dollar. NIH funding also supported more than 407,700 work that year.
President Donald Trump promised to “unlock the power of American innovation” to fight brain-based diseases when he accepted his second Republican nomination for president. About 6.7 million Americans live with Alzheimer's, and Parkinson's has suffered more than a million. Thousands of Americans are diagnosed with aggressive brain cancer every year, and 20% of the population experience various forms of mental illness at any time. These figures are expected to grow significantly and may double by 2050.
Organ research is just one of the important components of the brain learning process and uses this knowledge to find better treatments for diseases that affect the brain.
A scientific society will benefit society only when it is strictly, morally carried out and obtained reasonable funds. Current NIH policy directives and substantial cuts to agency size and budgets, as well as attacks on universities, undermine the common global goal of increasing understanding and improving human health.
Systems that federally monitor and fund biomedical sciences may require scalpels, but a “efficiency”-based funding effort is to wield chainsaws.