Christine Coughlin, Wake Forest University and Nancy M. P. King, Wake Forest University

As the Trump administration continues to make significant cuts to NIH budgets and personnel and to freeze billions of dollars of funding to major research universities – citing ideological concerns – there’s more being threatened than just progress in science and medicine. Something valuable but often overlooked is also being hit hard: preventing research abuse.

The National Institutes of Health has been the world’s largest public funder of biomedical research. Its support helps translate basic science into biomedical therapies and technologies, providing funding for nearly all treatments approved by the Food and Drug Administration from 2010 to 2019. This enables the U.S. to lead global research while maintaining transparency and preventing research misconduct.

While the legality of directives to shrink the NIH is unclear, the Trump administration’s actions have already led to suspended clinical trials, institutional hiring freezes and layoffs, rescinded graduate student admissions, and canceled federal grant review meetings. Researchers at affected universities say that funding will delay or possibly eliminate ongoing studies on critical conditions like cancer and Alzheimer’s.

It is clear to us, as legal and bioethics scholars whose research often focuses on the ethical, legal and social implications of emerging biotechnologies, that these directives will have profoundly negative consequences for medical research and human health, with ripple effects that will last decades. Our scholarship demonstrates that in order to contribute to knowledge and, ultimately, to biomedical treatments, medical research at every stage depends on significant infrastructure support and ethical oversight.

Our recent focus on brain organoid research – 3D lab models grown from human stem cells that simulate brain structure and function – shows how federal support for research is key to not only promote innovation, but to protect participants and future patients.

History of NIH and research ethics

The National Institutes of Health began as a one-room laboratory within the Marine Hospital Service in 1887. After World War I, chemists involved in the war effort sought to apply their knowledge to medicine. They partnered with Louisiana Sen. Joseph E. Ransdell who, motivated by the devastation of malaria, yellow fever and the 1928 influenza pandemic, introduced federal legislation to support basic research and fund fellowships focusing on solving medical problems.

By World War II, biomedical advances like surgical techniques and antibiotics had proved vital on the battlefield. Survival rates increased from 4% during World War I to 50% in World War II. Congress passed the 1944 Public Health Services Act to expand NIH’s authority to fund biomedical research at public and private institutions. President Franklin D. Roosevelt called it “as sound an investment as any Government can make; the dividends are payable in human life and health.”

As science advanced, so did the need for guardrails. After World War II, among the top Nazi leaders prosecuted for war crimes were physicians who conducted experiments on people without consent, such as exposure to hypothermia and infectious disease. The verdicts of these Doctors’ Trials included 10 points about ethical human research that became the Nuremberg Code, emphasizing voluntary consent to participation, societal benefit as the goal of human research, and significant limitations on permissible risks of harm. The World Medical Association established complementary international guidelines for physician-researchers in the 1964 Declaration of Helsinki.

In the 1970s, information about the Tuskegee study – a deceptive and unethical 40-year study of untreated syphilis in Black men – came to light. The researchers told study participants they would be given treatment but did not give them medication. They also prevented participants from accessing a cure when it became available in order to study the disease as it progressed. The men enrolled in the study experienced significant health problems, including blindness, mental impairment and death.

The public outrage that followed starkly demonstrated that the U.S. couldn’t simply rely on international guidelines but needed federal standards on research ethics. As a result, the National Research Act of 1974 led to the Belmont Report, which identified ethical principles essential to human research: respect for persons, beneficence and justice.

Federal regulations reinforced these principles by requiring all federally funded research to comply with rigorous ethical standards for human research. By prohibiting financial conflicts of interest and by implementing an independent ethics review process, new policies helped ensure that federally supported research has scientific and social value, is scientifically valid, fairly selects and adequately protects participants.

These standards and recommendations guide both federally and nonfederally funded research today. The breadth of NIH’s mandate and budget has provided not only the essential structure for research oversight, but also key resources for ethics consultation and advice.

Brain organoids and the need for ethical inquiry

Biomedical research on cell and animal models requires extensive ethics oversight systems that complement those for human research. Our research on the ethical and policy issues of human brain organoid research provides a good example of the complexities of biomedical research and the infrastructure and oversight mechanisms necessary to support it.

Organoid research is increasing in importance, as the FDA wants to expand its use as an alternative to using animals to test new drugs before administering them to humans. Because these models can simulate brain structure and function, brain organoid research is integral to developing and testing potential treatments for brain diseases and conditions like Alzheimer’s, Parkinson’s and cancer. Brain organoids are also useful for personalized and regenerative medicine, artificial intelligence, brain-computer interfaces and other biotechnologies.

Brain organoids are built on knowledge about the fundamentals of biology that was developed primarily in universities receiving federal funding. Organoid technology began in 1907 with research on sponge cells, and continued in the 1980s with advances in stem cell research. Since researchers generated the first human organoid in 2009, the field has rapidly expanded.

These advances were only possible through federally supported research infrastructure, which helps ensure the quality of all biomedical research. Indirect costs cover operational expenses necessary to maintain research safety and ethics, including utilities, administrative support, biohazard handling and regulatory compliance. In these ways, federally supported research infrastructure protects and promotes the scientific and ethical value of biotechnologies like brain organoids.

Brain organoid research requires significant scientific and ethical inquiry to safely reach its future potential. It raises potential moral and legal questions about donor consent, the extent to which organoids should be grown and how they should be disposed, and consciousness and personhood. As science progresses, infrastructure for oversight can help ensure these ethical and societal issues are addressed.

New frontiers in scientific research

Since World War II, there has been bipartisan support for scientific innovation, in part because it is an economic and national security imperative. As Harvard University President Alan Garber recently wrote, “[n]ew frontiers beckon us with the prospect of life-changing advances. … For the government to retreat from these partnerships now risks not only the health and well-being of millions of individuals but also the economic security and vitality of our nation.”

Cuts to research overhead may seem like easy savings, but it fails to account for the infrastructure that provides essential support for scientific innovation. The investment the NIH has put into academic research is significantly paid forward, adding nearly US$95 billion to local economies in fiscal year 2024, or $2.46 for every $1 of grant funding. NIH funding had also supported over 407,700 jobs that year.

President Donald Trump pledged to “unleash the power of American innovation” to battle brain-based diseases when he accepted his second Republican nomination for president. Around 6.7 million Americans live with Alzheimer’s, and over a million more suffer from Parkinson’s. Hundreds of thousands of Americans are diagnosed with aggressive brain cancers each year, and 20% of the population experiences varying forms of mental illness at any one time. These numbers are expected to grow considerably, possibly doubling by 2050.

Organoid research is just one of the essential components in the process of learning about the brain and using that knowledge to find better treatment for diseases affecting the brain.

Science benefits society only if it is rigorous, ethically conducted and fairly funded. Current NIH policy directives and steep cuts to the agency’s size and budget, along with attacks on universities, undermine globally shared goals of increasing understanding and improving human health.

The federal system of overseeing and funding biomedical science may need a scalpel, but to defund efforts based on “efficiency” is to wield a chainsaw.

Christine Coughlin, Professor of Law, Wake Forest University and Nancy M. P. King, Emeritus Professor of Social Sciences and Health Policy, Wake Forest University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Andrew Yockey, University of Mississippi

The U.S. Food and Drug Administration is warning Americans about the ever-increasing and potentially deadly recreational use of nitrous oxide products, particularly among young people.

Marketed with names like “Galaxy Gas” and “Miami Magic,” and often sold in steel cartridges known as “whippets,” these products are cheap and readily available at gas stations, convenience stores, smoke shops and major retail outlets, including Walmart. They’re also sold online.

As an assistant professor of public health who studies these products, I’m aware of how dangerous they can be.

Recreational and continued use of nitrous oxide can cause a wide range of serious health problems, and in some cases, death.

A long list of potential harms

The list of serious side effects from frequent use is long. It includes: cognitive impairment, memory problems, hallucinations, headaches, lightheadedness, mood disturbances, blood clots, limb weakness, trouble walking, peripheral neuropathy, impaired bowel or bladder function, spinal cord degeneration and irreversible brain damage. Vitamin B-12 deficiency is common and can lead to nerve and brain damage.

Deaths in the U.S. attributed to abuse of nitrous oxide jumped more than 100% between 2019 and 2023; over a five-year period, emergency department visits rose 32%.

All told, more than 13 million Americans have misused nitrous oxide at least once during their lifetimes. This includes children: In 2024, just over 4% of eighth graders and about 2% of 12th graders said they’ve tried inhalants. Nitrous oxide is among the most abused of these inhalants due to its low cost, easy availability and commercial appeal – one flavor of the gas is named “pink bubble gum.”

Laughing gas parties

Because of legal loopholes in the Food and Drug Administration Act, nitrous oxide remains unregulated. What’s more, U.S. scientists have done relatively little research on its abuse, partly because the public still perceives the substance as benign, particularly when compared with alcohol.

The few studies on the use of nitrous oxide are limited mainly to case reports – that is, a report on a single patient. Although limited in scope, they’re alarming.

More thorough studies are available in the United Kingdom and Europe, where there’s even more demand for the product. One example: Over a 20-year period, 56 people died in England and Wales after recreational use. Typically, deaths occur from hypoxia, which is the lack of oxygen to the brain, or accidents occurring while intoxicated by the gas, such as car wrecks or falls.

Americans have known about the effects of nitrous oxide for centuries. Before becoming a medicinal aid, nitrous oxide was popular at “laughing gas” parties during the late 1700s.

Physicians began using it in the U.S. around the mid-19th century after Horace Wells, a dentist, attended a stage show – called “Laughing Gas Entertainment” – and saw the numbing effect that nitrous oxide had on audience volunteers. By coincidence, Wells was having a wisdom tooth removed the next day, so he tried the gas during his procedure. The nitrous oxide worked; Wells said he felt no pain. Thereafter, medicinal use of the gas was gradually accepted.

Today, nitrous oxide is often used in dentist offices. It’s safe under a doctor’s supervision as a mild sedative that serves as a pain reliever and numbing agent.
Nitrous oxide also benefits some patients with severe psychiatric disorders, including treatment-resistant depression and bipolar depression. It may also help with anxiety and pain management.

Bans and restrictions

No federal age restrictions exist for purchasing nitrous oxide products, although a few states have passed age limits.

As of May 2025, four U.S. states – Louisiana, Michigan, Alabama and California – have banned the recreational use of nitrous oxide, and more than 30 states are working on legislation to ban or at least restrict sale of the products. In addition, numerous lawsuits filed against the manufacturers are in court.

Research shows school prevention programs help keep kids from using these products. So does early screening of patients by primary care and mental health physicians. The sooner they can intervene, the more likely that ongoing therapy will work.

Through appropriate legislation, regulation, education and intervention, nitrous oxide abuse can be slowed or stopped. Otherwise, these products – with their sleek packaging and attractive social media campaigns that obscure their dangers – remain a growing threat to our children.

Andrew Yockey, Assistant Professor of Public Health, University of Mississippi

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Bruce J. MacFadden, University of Florida

It might seem surprising, but federal research funding isn’t just for scientists. A component of many federal grants that support basic research requires that discoveries be shared with nonscientists. This component, referred to as “broader impacts” by the National Science Foundation, can make a big difference for K-12 students and teachers, museumgoers, citizen scientists and other people interested in science, while also helping the scientists themselves give back to the taxpayers that fund their work.

Basic research, often done because of a curious scientist’s interest, may not initially have a direct application, like developing the smartphone or curing a disease. But these discoveries build important knowledge in the natural sciences, engineering, mathematics and related disciplines.

The U.S. is a world leader in scientific and technological innovation. On the federal level, the National Science Foundation, or NSF, is one of the primary funders of this kind of basic research. In 2022, the federal government funded 40% of all basic research done in the U.S., with the remainder coming from other sources, including the business sector.

During World War II, President Franklin D. Roosevelt wanted to position the U.S. for strategic and economic leadership worldwide. He commissioned physicist Vannevar Bush to develop a vision for the future of U.S. science and technology. His 1945 report, “Science: the Endless Frontier,” became the blueprint for government-funded basic research. In 1950, Congress created the National Science Foundation to promote the progress of science, advance national prosperity and welfare and secure the national defense.

During the early decades of NSF, the 1950s until the late 1990s, proposals were mostly evaluated based on the quality of the science and the scientists doing the work. But then, the foundation created a new system, still in place today.

Thus, each NSF research proposal is now peer-reviewed based on two criteria: intellectual merit, or the quality and novelty of the science and track record of the research team, and “broader impacts” – related activities that disseminate the discoveries to general audiences.

Intellectual merit is about advancing science knowledge and innovation, while broader impacts describe why people who aren’t scientists should care, and how society could benefit from this research.

Another pragmatic aspect to broader impacts is that taxpayers pay for these activities, so it’s important for them, and Congress, to understand their return on investment. These broader impacts activities communicate about, and engage the public in, research in a variety of ways.

While researchers usually understand the intellectual merit of their NSF-funded projects, these broader impacts can be challenging to characterize.

Broader impact activities

Since childhood, I’ve had an interest in paleontology — the study of fossils and what we can learn from them about prehistoric life. This field is primarily basic research — adding to knowledge about ancient life. As a scientist conducting basic research, I’ve felt the responsibility to give back to society through broader impacts activities, and I’ve seen many of the benefits that these activities can have.

My primary area of interest has been extinct mammals of the Americas, particularly the 55-million-year-old record of fossil horses on this continent. For years, NSF supported my discoveries about this interesting group of animals. Fossil horses are a classic example of evolution — in books and museum exhibits.

Many people are generally interested in horses, so it’s easy to attract their attention with this charismatic group. They also are often surprised to learn that prehistoric horses were native to North America for millions of years. Then, during historical times, they were first introduced by humans onto the continent about 500 years ago.

Over the years, my research team has used grant-funded broader impact activities to teach people about these fossil horses and our research. One example included working with K-12 science teachers to develop lesson plans. The students measured fossil horse teeth and explored how their teeth adapted to feeding on grasses. We’ve also developed exhibits on fossil horses and studied how they communicate science to museum visitors.

Science teachers have joined our fieldwork to collect fossils along the Panama Canal during its recent expansion. I’ve given many talks and collaborated with fossil clubs and their members throughout the U.S. We’ve also promoted projects like Fossils4Teachers where fossil collectors donated their fossils and worked alongside K-12 teachers to develop lesson plans that were implemented back in the teachers’ classrooms.

We’ve also been able to activate peoples’ interest in other animal groups — such as fossil sharks. Through our Scientist in Every Florida School program, we gave middle school teachers study kits with real fossil shark teeth. Their students learned to identify the shark teeth and then trained computers to identify the teeth using machine learning, a type of artificial intelligence.

Broader impact outcomes

Broader impacts activities like these can have a variety of short- and long-term outcomes. More than 50 million people visit natural history museums in the U.S. annually. Activities that promote museums can reach large numbers of people in their pursuit of lifelong learning.

More broadly, participatory science interest groups can allow people to learn about science while informing basic research projects. Within the field of natural history, a few popular examples include the Merlin app and the iNaturalist app, both of which have millions of active observers. Merlin encourages people to submit their observations of birds, and iNaturalist accepts sightings of plants, animals and fossils, which researchers can carefully vet and use as data.

Many of the K-12 teachers my team has worked with report that they feel more confident teaching the new science content that they learned from our collaborations.

Interestingly, although much of the research on science professional development focuses on the teachers, scientists also report a high level of satisfaction and improved communication skills after working with these teachers, both in the field and back in the classroom.

Basic research benefits for society

Generations of U.S. scientists have greatly benefited from federal investments in basic research. In the 75 years since NSF’s founding, the organization has funded hundreds of thousand projects to advance science and technology.

These have supported basic research discoveries and also the training and career development of the tens of thousands of scientists working on these projects annually.

Many prominent scientists have gone on to be productive leaders and innovators in the U.S. and internationally. NSF has funded more than 268 Nobel laureates.

While NSF invests in the discovery of foundational knowledge about the natural world, funded projects have not traditionally had direct applications for societal benefits. To be sure, however, many of NSF’s projects – for example, on lasers and nanotechnology – started out as curiosity-driven basic research and ended up with immense applications for technological innovation and economic prosperity.

For example, mapping the Earth’s ocean floor’s magnetic properties during World War II helped scientists understand how the crust moves and mountains form. This led to the plate tectonic revolution in the earth sciences. This line of basic research then led to an important application: predicting the probable location of high-risk earthquake zones worldwide.

None of these downstream applications and benefits to society would have been realized without basic research discoveries supported by federal agencies such as NSF, and the further value added through broader impacts activities.

Bruce J. MacFadden, Distinguished Professor Emeritus, University of Florida

This article is republished from The Conversation under a Creative Commons license. Read the original article.