Latest news with #PublicHealthServicesAct
CNN
7 days ago
- Health
- CNN
States, cities face loss of vaccination programs and staff after ‘baffling' cuts to federal funding
Millions of dollars have been pulled from state and local vaccination programs with no explanation, after a review of the funding agreements by the US Department of Health and Human Services. Affected programs say they will probably have to cut staffers and services because of the shortfall, and they worry that vaccination rates will also drop as they lose the ability to assist people who are low-income or uninsured. Immunization programs across the country are already struggling to address an increase in vaccine-preventable diseases. These include pertussis – also known as whooping cough – which has sickened more than 10,000 Americans and killed five children this year, as well as a smoldering outbreak of measles that has killed three people in the US and threatens to end the country's elimination status. 'That's the baffling part,' said one policy expert who spoke to CNN on the condition that they not be named for fear of government retaliation. 'Why anyone would create this disruption in the midst of the worst measles outbreak in 30 years.' Most money spent by states on vaccination comes from the federal government. The grant money, which is appropriated by Congress under Section 317 of the Public Health Services Act, enables states, territories and some large cities to collect data on vaccination, as well as provide shots to underserved children and adults. The funds also help monitor the safety of vaccines and fight misinformation. The money is doled out in five-year grants overseen by US Centers for Disease Control and Prevention, and the most recent awards were due to states on July 1. This year, however, HHS conducted lengthy reviews of the awards, which delayed their arrival in some cases. HHS Director of Communications Andrew Nixon said the reviews were part of agency cost-cutting efforts. 'The Defend the Spend initiative is a department-wide effort to ensure that taxpayer dollars are being used effectively, transparently, and in alignment with this administration,' Nixon said in a statement to CNN. 'As part of this oversight, grant recipients may be asked to provide additional information, which is essential to preventing waste, fraud, and abuse. HHS is committed to working all grantees to resolve outstanding issues as quickly as possible while maintaining the highest standards of accountability.' Public health advocates say the latest funding cuts appear to be part of a larger pattern of efforts by HHS Secretary Robert F. Kennedy Jr. to disrupt and dismantle the America's vaccination infrastructure. 'Millions of children missed their routine vaccinations during the pandemic,' and never caught back up said Dr. Caitlin Rivers, director of the Center for Response Outbreak Innovation at the Johns Hopkins Bloomberg School of Public Health. Vaccine hesitancy has also increased, driven by a deluge of misinformation, some of it now coming from official channels. As a result, vaccination rates have dropped, and some communities are no longer protected by herd immunity, the threshold of vaccination required to prevent certain infectious diseases from easily spreading. If state vaccination programs are not adequately resourced, 'we're just going to continue to fall further and further behind, and that sets the stage for things like measles and pertussis outbreaks, which we're seeing,' Rivers said. Public health programs often become victims of their own success, she said. 'When there is a large public health emergency … there are huge investments made in public health, because we can see very clearly what the consequences are of having inadequate resourcing and inadequate infrastructure. But over time, those investments begin to work, and the threats recede, and we start to forget why it's so important to maintain those defenses,' Rivers said. 'And I think now, five years out of Covid, we're very clearly in the neglect cycle, and we're seeing a lot of the investments we made during the pandemic be pulled back,' she added. Of 66 jurisdictions awarded federal immunization funding this year, about 40 received awards lower than their funding targets. And more than a dozen states and cities received lower awards this year than they did in 2019, just before the Covid-19 pandemic began, the last time these awards were offered through the CDC, according to a CNN analysis of federal data. Massachusetts, New York, Indiana, California and Arizona were among those awarded less this year than in 2019, the year before the Covid-19 pandemic began. 'That's really, really unbelievable to us,' said one public health advocate who asked not to be named for fear of political retaliation for speaking out against the cuts. 'How could we come out of a pandemic with half of states being less prepared?' Other states found that their awards were far lower than they'd been told to expect. In January 2025, the CDC sent out a Notice of Funding Opportunity – essentially an invitation – to states, territories and certain large cities. It came with a funding target: the amount they could expect if their grant proposals were accepted. Washington, for example, was told it could expect about $9.5 million, so the Department of Health planned for that amount for the 2026 fiscal year. When the state got its Notice of Award on July 1, however, it was for $7.8 million, an 18% reduction. Massachusetts was told it could expect $7.7 million for the upcoming fiscal year, already a 20% reduction from its 2025 budget. When the award arrived, it was $1 million under the targeted amount, at $6.7 million, which means the department expects to operate with about 30% less funding next year than it has this year. Colorado received almost $500,000 less than it expected, a decrease of about 5% from the amount it budgeted for, according to federal data California, Illinois, Michigan and New York also received lower-than-expected funding awards, according to a CNN analysis of federal data. Sometimes, the delays and errors in funding caused chaos: At least one state, Idaho, furloughed its immunization program staff with no notice after the money didn't arrive when expected. When the award did come through a day later, they were put back to work, but medical providers who reached out in the interim to submit their regular data updates had no one to help them and didn't know when services would be restored. The cuts didn't just affect state health departments. The city of New Haven, Connecticut, had to lay off immunization positions that were supported by subawards it receives from the state grant. When the grant didn't arrive in time, the state directed the city not to incur any more expenses, and when the federal money did come through, it was 20% less than anticipated. Chicago is also preparing to lay off immunization workers, according to multiple sources with knowledge of the city's plans, who asked not to be named because they feared retaliation by the Trump administration. Not all awardees saw reductions, however. About two dozen jurisdictions, including Alabama, Idaho and Wyoming and Montana, got significant funding increases over their award targets for this year. State officials who spoke to CNN for this story say they were given no explanation for why the awards were reduced or increased this cycle. The cuts come on top of the loss of billions in unspent Covid relief funding that was being used by states, in part, to help staff immunization programs. In late March, HHS directed the CDC to roll back about $11.4 billion in Covid-era funding granted to state and local health departments. Another $1 billion was reclaimed from the Substance Abuse and Mental Health Services Administration. A survey conducted by the Association of Immunization Managers found that the Covid money clawback alone has led to the elimination 579 staff positions in state vaccination programs. After the new grant cuts, some jurisdictions said they would probably need to lay off even more workers but were trying to assess the changes that would be needed. Some programs said they hoped state funding could help fill the gaps. In the past, the funding amounts that jurisdictions were told they could expect have been determined by a relatively simple formula that primarily relied on an area's population. This year, however, federal officials deployed a more complicated formula that took into account population levels as well as how much of a state was rural and how many providers participate in the Vaccines for Children program compared with the overall population, according to a public health advocate familiar with the awards who asked not to be named for fear of political retaliation. Immunization programs were told they could expect about $418 million in funding. All told, what they were awarded totaled roughly $398 million. Changes to the funding formula don't appear to account for the reductions, however. The formula was applied to the target amounts that were distributed in January. Instead, changes to the awards came after the HHS review, which in some cases delayed the release of the money and left programs hanging. Hawaii, for example, received authorization to borrow up to $100,000 from the state government to pay salaries and cover operational expenses until its award came through, about two weeks late. Public health advocates blasted the funding decision. 'Stripping 317 waiver funds combined with other losses is starving state and local public health budgets and is not just short-sighted, it's reckless,' said Dr. Brian Castrucci, president and chief executive officer of the nonprofit deBeaumont Foundation, which advocates for the public health workforce. 'We're watching the deliberate dismantling of the public health safety net in real time,' Castrucci said.
CNN
7 days ago
- Health
- CNN
States, cities face loss of vaccination programs and staff after ‘baffling' cuts to federal funding
Vaccines Federal agencies Children's healthFacebookTweetLink Follow Millions of dollars have been pulled from state and local vaccination programs with no explanation, after a review of the funding agreements by the US Department of Health and Human Services. Affected programs say they will probably have to cut staffers and services because of the shortfall, and they worry that vaccination rates will also drop as they lose the ability to assist people who are low-income or uninsured. Immunization programs across the country are already struggling to address an increase in vaccine-preventable diseases. These include pertussis – also known as whooping cough – which has sickened more than 10,000 Americans and killed five children this year, as well as a smoldering outbreak of measles that has killed three people in the US and threatens to end the country's elimination status. 'That's the baffling part,' said one policy expert who spoke to CNN on the condition that they not be named for fear of government retaliation. 'Why anyone would create this disruption in the midst of the worst measles outbreak in 30 years.' Most money spent by states on vaccination comes from the federal government. The grant money, which is appropriated by Congress under Section 317 of the Public Health Services Act, enables states, territories and some large cities to collect data on vaccination, as well as provide shots to underserved children and adults. The funds also help monitor the safety of vaccines and fight misinformation. The money is doled out in five-year grants overseen by US Centers for Disease Control and Prevention, and the most recent awards were due to states on July 1. This year, however, HHS conducted lengthy reviews of the awards, which delayed their arrival in some cases. HHS Director of Communications Andrew Nixon said the reviews were part of agency cost-cutting efforts. 'The Defend the Spend initiative is a department-wide effort to ensure that taxpayer dollars are being used effectively, transparently, and in alignment with this administration,' Nixon said in a statement to CNN. 'As part of this oversight, grant recipients may be asked to provide additional information, which is essential to preventing waste, fraud, and abuse. HHS is committed to working all grantees to resolve outstanding issues as quickly as possible while maintaining the highest standards of accountability.' Public health advocates say the latest funding cuts appear to be part of a larger pattern of efforts by HHS Secretary Robert F. Kennedy Jr. to disrupt and dismantle the America's vaccination infrastructure. 'Millions of children missed their routine vaccinations during the pandemic,' and never caught back up said Dr. Caitlin Rivers, director of the Center for Response Outbreak Innovation at the Johns Hopkins Bloomberg School of Public Health. Vaccine hesitancy has also increased, driven by a deluge of misinformation, some of it now coming from official channels. As a result, vaccination rates have dropped, and some communities are no longer protected by herd immunity, the threshold of vaccination required to prevent certain infectious diseases from easily spreading. If state vaccination programs are not adequately resourced, 'we're just going to continue to fall further and further behind, and that sets the stage for things like measles and pertussis outbreaks, which we're seeing,' Rivers said. Public health programs often become victims of their own success, she said. 'When there is a large public health emergency … there are huge investments made in public health, because we can see very clearly what the consequences are of having inadequate resourcing and inadequate infrastructure. But over time, those investments begin to work, and the threats recede, and we start to forget why it's so important to maintain those defenses,' Rivers said. 'And I think now, five years out of Covid, we're very clearly in the neglect cycle, and we're seeing a lot of the investments we made during the pandemic be pulled back,' she added. Of 66 jurisdictions awarded federal immunization funding this year, about 40 received awards lower than their funding targets. And more than a dozen states and cities received lower awards this year than they did in 2019, just before the Covid-19 pandemic began, the last time these awards were offered through the CDC, according to a CNN analysis of federal data. Massachusetts, New York, Indiana, California and Arizona were among those awarded less this year than in 2019, the year before the Covid-19 pandemic began. 'That's really, really unbelievable to us,' said one public health advocate who asked not to be named for fear of political retaliation for speaking out against the cuts. 'How could we come out of a pandemic with half of states being less prepared?' Other states found that their awards were far lower than they'd been told to expect. In January 2025, the CDC sent out a Notice of Funding Opportunity – essentially an invitation – to states, territories and certain large cities. It came with a funding target: the amount they could expect if their grant proposals were accepted. Washington, for example, was told it could expect about $9.5 million, so the Department of Health planned for that amount for the 2026 fiscal year. When the state got its Notice of Award on July 1, however, it was for $7.8 million, an 18% reduction. Massachusetts was told it could expect $7.7 million for the upcoming fiscal year, already a 20% reduction from its 2025 budget. When the award arrived, it was $1 million under the targeted amount, at $6.7 million, which means the department expects to operate with about 30% less funding next year than it has this year. Colorado received almost $500,000 less than it expected, a decrease of about 5% from the amount it budgeted for, according to federal data California, Illinois, Michigan and New York also received lower-than-expected funding awards, according to a CNN analysis of federal data. Sometimes, the delays and errors in funding caused chaos: At least one state, Idaho, furloughed its immunization program staff with no notice after the money didn't arrive when expected. When the award did come through a day later, they were put back to work, but medical providers who reached out in the interim to submit their regular data updates had no one to help them and didn't know when services would be restored. The cuts didn't just affect state health departments. The city of New Haven, Connecticut, had to lay off immunization positions that were supported by subawards it receives from the state grant. When the grant didn't arrive in time, the state directed the city not to incur any more expenses, and when the federal money did come through, it was 20% less than anticipated. Chicago is also preparing to lay off immunization workers, according to multiple sources with knowledge of the city's plans, who asked not to be named because they feared retaliation by the Trump administration. Not all awardees saw reductions, however. About two dozen jurisdictions, including Alabama, Idaho and Wyoming and Montana, got significant funding increases over their award targets for this year. State officials who spoke to CNN for this story say they were given no explanation for why the awards were reduced or increased this cycle. The cuts come on top of the loss of billions in unspent Covid relief funding that was being used by states, in part, to help staff immunization programs. In late March, HHS directed the CDC to roll back about $11.4 billion in Covid-era funding granted to state and local health departments. Another $1 billion was reclaimed from the Substance Abuse and Mental Health Services Administration. A survey conducted by the Association of Immunization Managers found that the Covid money clawback alone has led to the elimination 579 staff positions in state vaccination programs. After the new grant cuts, some jurisdictions said they would probably need to lay off even more workers but were trying to assess the changes that would be needed. Some programs said they hoped state funding could help fill the gaps. In the past, the funding amounts that jurisdictions were told they could expect have been determined by a relatively simple formula that primarily relied on an area's population. This year, however, federal officials deployed a more complicated formula that took into account population levels as well as how much of a state was rural and how many providers participate in the Vaccines for Children program compared with the overall population, according to a public health advocate familiar with the awards who asked not to be named for fear of political retaliation. Immunization programs were told they could expect about $418 million in funding. All told, what they were awarded totaled roughly $398 million. Changes to the funding formula don't appear to account for the reductions, however. The formula was applied to the target amounts that were distributed in January. Instead, changes to the awards came after the HHS review, which in some cases delayed the release of the money and left programs hanging. Hawaii, for example, received authorization to borrow up to $100,000 from the state government to pay salaries and cover operational expenses until its award came through, about two weeks late. Public health advocates blasted the funding decision. 'Stripping 317 waiver funds combined with other losses is starving state and local public health budgets and is not just short-sighted, it's reckless,' said Dr. Brian Castrucci, president and chief executive officer of the nonprofit deBeaumont Foundation, which advocates for the public health workforce. 'We're watching the deliberate dismantling of the public health safety net in real time,' Castrucci said.
CNN
7 days ago
- Health
- CNN
States, cities face loss of vaccination programs and staff after ‘baffling' cuts to federal funding
Millions of dollars have been pulled from state and local vaccination programs with no explanation, after a review of the funding agreements by the US Department of Health and Human Services. Affected programs say they will probably have to cut staffers and services because of the shortfall, and they worry that vaccination rates will also drop as they lose the ability to assist people who are low-income or uninsured. Immunization programs across the country are already struggling to address an increase in vaccine-preventable diseases. These include pertussis – also known as whooping cough – which has sickened more than 10,000 Americans and killed five children this year, as well as a smoldering outbreak of measles that has killed three people in the US and threatens to end the country's elimination status. 'That's the baffling part,' said one policy expert who spoke to CNN on the condition that they not be named for fear of government retaliation. 'Why anyone would create this disruption in the midst of the worst measles outbreak in 30 years.' Most money spent by states on vaccination comes from the federal government. The grant money, which is appropriated by Congress under Section 317 of the Public Health Services Act, enables states, territories and some large cities to collect data on vaccination, as well as provide shots to underserved children and adults. The funds also help monitor the safety of vaccines and fight misinformation. The money is doled out in five-year grants overseen by US Centers for Disease Control and Prevention, and the most recent awards were due to states on July 1. This year, however, HHS conducted lengthy reviews of the awards, which delayed their arrival in some cases. HHS Director of Communications Andrew Nixon said the reviews were part of agency cost-cutting efforts. 'The Defend the Spend initiative is a department-wide effort to ensure that taxpayer dollars are being used effectively, transparently, and in alignment with this administration,' Nixon said in a statement to CNN. 'As part of this oversight, grant recipients may be asked to provide additional information, which is essential to preventing waste, fraud, and abuse. HHS is committed to working all grantees to resolve outstanding issues as quickly as possible while maintaining the highest standards of accountability.' Public health advocates say the latest funding cuts appear to be part of a larger pattern of efforts by HHS Secretary Robert F. Kennedy Jr. to disrupt and dismantle the America's vaccination infrastructure. 'Millions of children missed their routine vaccinations during the pandemic,' and never caught back up said Dr. Caitlin Rivers, director of the Center for Response Outbreak Innovation at the Johns Hopkins Bloomberg School of Public Health. Vaccine hesitancy has also increased, driven by a deluge of misinformation, some of it now coming from official channels. As a result, vaccination rates have dropped, and some communities are no longer protected by herd immunity, the threshold of vaccination required to prevent certain infectious diseases from easily spreading. If state vaccination programs are not adequately resourced, 'we're just going to continue to fall further and further behind, and that sets the stage for things like measles and pertussis outbreaks, which we're seeing,' Rivers said. Public health programs often become victims of their own success, she said. 'When there is a large public health emergency … there are huge investments made in public health, because we can see very clearly what the consequences are of having inadequate resourcing and inadequate infrastructure. But over time, those investments begin to work, and the threats recede, and we start to forget why it's so important to maintain those defenses,' Rivers said. 'And I think now, five years out of Covid, we're very clearly in the neglect cycle, and we're seeing a lot of the investments we made during the pandemic be pulled back,' she added. Of 66 jurisdictions awarded federal immunization funding this year, about 40 received awards lower than their funding targets. And more than a dozen states and cities received lower awards this year than they did in 2019, just before the Covid-19 pandemic began, the last time these awards were offered through the CDC, according to a CNN analysis of federal data. Massachusetts, New York, Indiana, California and Arizona were among those awarded less this year than in 2019, the year before the Covid-19 pandemic began. 'That's really, really unbelievable to us,' said one public health advocate who asked not to be named for fear of political retaliation for speaking out against the cuts. 'How could we come out of a pandemic with half of states being less prepared?' Other states found that their awards were far lower than they'd been told to expect. In January 2025, the CDC sent out a Notice of Funding Opportunity – essentially an invitation – to states, territories and certain large cities. It came with a funding target: the amount they could expect if their grant proposals were accepted. Washington, for example, was told it could expect about $9.5 million, so the Department of Health planned for that amount for the 2026 fiscal year. When the state got its Notice of Award on July 1, however, it was for $7.8 million, an 18% reduction. Massachusetts was told it could expect $7.7 million for the upcoming fiscal year, already a 20% reduction from its 2025 budget. When the award arrived, it was $1 million under the targeted amount, at $6.7 million, which means the department expects to operate with about 30% less funding next year than it has this year. Colorado received almost $500,000 less than it expected, a decrease of about 5% from the amount it budgeted for, according to federal data California, Illinois, Michigan and New York also received lower-than-expected funding awards, according to a CNN analysis of federal data. Sometimes, the delays and errors in funding caused chaos: At least one state, Idaho, furloughed its immunization program staff with no notice after the money didn't arrive when expected. When the award did come through a day later, they were put back to work, but medical providers who reached out in the interim to submit their regular data updates had no one to help them and didn't know when services would be restored. The cuts didn't just affect state health departments. The city of New Haven, Connecticut, had to lay off immunization positions that were supported by subawards it receives from the state grant. When the grant didn't arrive in time, the state directed the city not to incur any more expenses, and when the federal money did come through, it was 20% less than anticipated. Chicago is also preparing to lay off immunization workers, according to multiple sources with knowledge of the city's plans, who asked not to be named because they feared retaliation by the Trump administration. Not all awardees saw reductions, however. About two dozen jurisdictions, including Alabama, Idaho and Wyoming and Montana, got significant funding increases over their award targets for this year. State officials who spoke to CNN for this story say they were given no explanation for why the awards were reduced or increased this cycle. The cuts come on top of the loss of billions in unspent Covid relief funding that was being used by states, in part, to help staff immunization programs. In late March, HHS directed the CDC to roll back about $11.4 billion in Covid-era funding granted to state and local health departments. Another $1 billion was reclaimed from the Substance Abuse and Mental Health Services Administration. A survey conducted by the Association of Immunization Managers found that the Covid money clawback alone has led to the elimination 579 staff positions in state vaccination programs. After the new grant cuts, some jurisdictions said they would probably need to lay off even more workers but were trying to assess the changes that would be needed. Some programs said they hoped state funding could help fill the gaps. In the past, the funding amounts that jurisdictions were told they could expect have been determined by a relatively simple formula that primarily relied on an area's population. This year, however, federal officials deployed a more complicated formula that took into account population levels as well as how much of a state was rural and how many providers participate in the Vaccines for Children program compared with the overall population, according to a public health advocate familiar with the awards who asked not to be named for fear of political retaliation. Immunization programs were told they could expect about $418 million in funding. All told, what they were awarded totaled roughly $398 million. Changes to the funding formula don't appear to account for the reductions, however. The formula was applied to the target amounts that were distributed in January. Instead, changes to the awards came after the HHS review, which in some cases delayed the release of the money and left programs hanging. Hawaii, for example, received authorization to borrow up to $100,000 from the state government to pay salaries and cover operational expenses until its award came through, about two weeks late. Public health advocates blasted the funding decision. 'Stripping 317 waiver funds combined with other losses is starving state and local public health budgets and is not just short-sighted, it's reckless,' said Dr. Brian Castrucci, president and chief executive officer of the nonprofit deBeaumont Foundation, which advocates for the public health workforce. 'We're watching the deliberate dismantling of the public health safety net in real time,' Castrucci said.
Yahoo
09-05-2025
- Health
- Yahoo
Science requires ethical oversight – without federal dollars, society's health and safety are at risk
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. 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. 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. 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. This article is republished from The Conversation, a nonprofit, independent news organization bringing you facts and trustworthy analysis to help you make sense of our complex world. It was written by: Christine Coughlin, Wake Forest University and Nancy M. P. King, Wake Forest University Read more: Tenacious curiosity in the lab can lead to a Nobel Prize – mRNA research exemplifies the unpredictable value of basic scientific research Cuts to science research funding cut American lives short − federal support is essential for medical breakthroughs Cancer research in the US is world class because of its broad base of funding − with the government pulling out, its future is uncertain The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.
