![\"Replacement](\"https:\/\/i0.wp.com\/www.animals24-7.org\/wp-content\/uploads\/Picsart_25-05-16_18-24-43-887-e1747447625802.jpg?ssl=1\")
<\/a><\/p>\n(Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n [Morgan V. Sage, \u00a0a longtime ANIMALS 24-7 reader and close observer of biomedical research, \u00a0offers the following commentary on the issues raised by our May 4, \u00a02025 article \u201c<\/strong>Is NIH under Trump really replacing animal testing, or just axing research?\u201d]<\/strong><\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n The\u00a0\u201c3Rs\u201d\u00a0\u2013 Replacement, Reduction, and Refinement \u2013 are guiding principles for minimizing animal use and suffering in research while improving scientific quality.<\/p>\n First articulated in 1959 by Charles Russell and Rex Burch,\u00a0 the \u201c3Rs\u201d call for replacing sentient animals with non-animal methods where possible, \u00a0reducing the number of animals used, and refining procedures to lessen pain or distress.<\/p>\n Today the 3Rs are embedded in many national laws and guidelines and in research best practices. Advocates for the 3Rs approach emphasize that non-animal research methods often yield data more relevant to humans.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Major biomedical funders have begun to prioritize human-relevant,\u00a0 non-animal-using approaches. \u00a0The National Institutes of Health [NIH],\u00a0 for instance,\u00a0 in April 2025 announced creation of the Office of Research Innovation, Validation, and Application (ORIVA) with a mandate to \u201cdevelop, validate, and scale\u201d human-based methods as alternatives to animal studies.<\/p>\n The NIH pledged to \u201cexpand funding and training in non-animal approaches,\u201d add review criteria prioritizing human-relevance, \u00a0and publicly report annually on funding shifts from animal to human-based research.<\/p>\n These steps build on recent NIH advisory activities,\u00a0 including that a 2024 advisory committee report on catalyzing non-animal methods was adopted, \u00a0and a new program,\u00a0 Complement-ARIE,\u00a0 was launched to accelerate development and validation of non-animal methods.<\/p>\n Similarly, \u00a0the FDA has signaled shifts toward human-based testing,\u00a0 for example phasing out animal requirements for certain biologics.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Outside of government, non-profit centers also drive 3Rs acceptance. \u00a0The United Kingdom\u2019s NC3Rs \u2013 funded by government \u2013 has an annual budget around \u00a37\u202fmillion and has awarded over \u00a335\u202fmillion for 3Rs projects since 2004.<\/p>\n Johns Hopkins\u2019\u00a0Center for Alternatives to Animal Testing similarly offers funding and resources for 3Rs research and publishes the peer-reviewed journal\u00a0ALTEX,\u00a0 <\/em>focused on alternatives to animal research.<\/p>\n Several U.S. agencies,\u00a0 including the NIH,\u00a0 the Environmental Protection Agency, \u00a0and the Department of Defense,\u00a0 and industry consortia in the toxicology and pharmaceutical arena, \u00a0have also allocated internal budgets to develop and use non-animal methods.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Philanthropic funders have a role as well.\u00a0 The International Foundation for Ethical Research explicitly supports alternative method development.<\/p>\n Despite these efforts, \u00a0most biomedical research still relies on animal studies. \u00a0The NIH still devotes a substantial share of its multi-billion dollar budget to animal-based grants.<\/p>\n Overall, the\u00a0state of 3Rs research\u00a0is mixed.\u00a0 Many promising technologies and policies are emerging, but they are still a small part of the overall biomedical enterprise.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Public research agencies\u00a0including the NIH, \u00a0Centers for Disease Control & Prevention,\u00a0 Food & Drug Administration,\u00a0 and the National Science Foundation have traditionally underwritten much biomedical research and development, \u00a0including animal studies.<\/p>\n Many analysts argue these agencies should likewise allocate meaningful funding specifically for 3Rs research.<\/p>\n In the United Kingdom and European Union, \u00a0governments finance national 3Rs centers and require regulators to consider alternatives in testing programs.<\/p>\n Industry\u00a0also has a strong incentive to support 3Rs research.\u00a0 Non-animal methods can reduce late-stage drug failures and testing costs, \u00a0so pharmaceutical, \u00a0chemical, \u00a0and consumer product makers invest in in 3Rs approaches.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Some universities allocate institutional funds for developing human-relevant models or improving animal welfare, \u00a0but these contributions are modest.<\/p>\n Experts note that\u00a03Rs research is underfunded\u00a0relative to its importance, \u00a0urging a broader funding base.<\/p>\n In short, while NIH and similar bodies currently lead funding, fulfilling the potential of the 3Rs likely requires\u00a0shared responsibility\u00a0among governments, \u00a0industry, \u00a0nonprofits, \u00a0and academia.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Because agencies like the National Institutes of Health are funded by taxpayers, \u00a0there is a strong public interest in how effectively they drive ethical and effective science.<\/p>\n The NIH signaled a new role as a coordinator of 3Rs innovation by placing the new Office of Research Innovation, Validation, \u00a0and Application\u00a0(ORIVA) in NIH director\u2019 Jay Bhattacharya\u2019s office to \u201ccoordinate NIH-wide efforts\u201d on non-animal methods and to \u201cserve as a hub for interagency coordination and regulatory translation.\u201d<\/p>\n The NIH also says it plans to train grant reviewers to recognize and mitigate \u201canimal methods bias,\u201d \u00a0to ensure that grant peer review itself does not unduly favor traditional animal models.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Public accountability can be reinforced by metrics and oversight. \u00a0The NIH press release announcing the formation of ORIVA explicitly committed to\u00a0annual public reporting\u00a0on spending, \u00a0tracking reductions in animal-based funding and increases in human-based methods.<\/p>\n Such transparency allows Congress and the public to see whether promises translate into budgetary shifts.<\/p>\n Congress could further hold agencies accountable by requiring set-asides or milestones for 3Rs progress.<\/p>\n Yet the broader context is in flux. Major proposals to\u00a0restructure NIH\u00a0and slash its budget have been floated in the U.S. budget process,\u00a0 including a plan to collapse the NIH\u2019s 27 institutes into five and cut NIH funding from $47 billion in 2025 to $27 billion in 2026.<\/p>\n (PETA photo)<\/strong><\/em><\/p>\n<\/div>\n Although these proposals are preliminary and controversial, they illustrate pressure to make NIH more efficient. \u00a0Skeptics worry that under tight budgets, agencies might tout the 3Rs as a cost-saving measure rather than a science-driven priority.<\/p>\n In this climate, oversight by Congress, scientific advisory panels, and the public is vital to ensure 3Rs initiatives are evidence-based and fully funded, not just lip service.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n To judge progress in the 3Rs, stakeholders stress the need for clear metrics. Possible measures include:<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Reactions to the recent NIH steps toward emphasizing non-animal methods illustrate contrasting views.<\/p>\n Advocacy groups\u00a0like the Physicians Committee for Responsible Medicine [PCRM] hail ORIVA and related actions as long overdue and transformative. \u00a0PCRM calls the NIH pledge to \u201cprioritize human-based science\u201d a \u201chistoric announcement\u201d and a \u201cbig win for animals and human health,\u201d\u00a0 pointing out that animal experiments \u201ccome at a grave cost.\u201d<\/p>\n PCRM notes that NIH has \u201csteadily increased\u201d investment in non-animal methods, \u00a0but still has far to go.<\/p>\n In contrast,\u00a0 some researchers and industry groups\u00a0are cautious.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n For example, \u00a0the National Association for Biomedical Research (NABR), \u00a0representing laboratories and biotech since 1979, \u00a0welcomed innovation but warned that \u201cno AI model or simulation has yet demonstrated the ability to fully replicate all the unknowns about many full biological systems.\u201d<\/p>\n Similarly,\u00a0 many scientists note that although animals are imperfect models,\u00a0 they remain necessary in some fields until alternatives are validated.\u00a0 Some fear that mandating reduction targets too aggressively could inadvertently impede research progress if suitable alternatives are not yet available for certain studies.<\/p>\n Another line of critique focuses on motive.\u00a0 Skeptics ask whether NIH\u2019s 3Rs emphasis is a science-driven initiative or a byproduct of budget pressure.<\/p>\n NIH has not disclosed ORIVA\u2019s budget or staff, \u00a0fueling uncertainty. \u00a0If major funding cuts occur, critics worry Congress or agency leadership might force researchers to use fewer animals as a budget-saving measure, \u00a0rather than a carefully planned pivot.<\/p>\n Defenders point out that the 3Rs effort predates the budget debate,\u00a0 and argue that moving toward more effective science should be a priority in any case.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n Framed as a public good, 3Rs research yields wide benefits if properly supported.<\/p>\n Potential beneficiaries include patients,\u00a0 scientists,\u00a0 taxpayers,\u00a0 and \u2013 critically \u2013 animals.<\/p>\n Conversely, \u00a0the\u00a0costs\u00a0involve up-front investment in new technologies, \u00a0training of researchers in new methods, and possible short-term slowdowns as fields adapt.<\/p>\n These costs must be weighed against the current \u201chidden\u201d costs of animal research: \u00a0failed drugs, \u00a0translational failures, \u00a0and ethical harms.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n So who bears the responsibility\u2014especially under fiscal constraint\u2013\u2013for funding non-animal methods research?<\/p>\n Think of science as a big garden. \u00a0Until now, \u00a0everyone believed the public gardeners\u2013\u2013the government\u2013\u2013were responsible for planting and watering the seeds of new, \u00a0kinder ways to test medicines.<\/p>\n But now, \u00a0people are arguing,\u00a0 rightly or wrongly,\u00a0 that there is not enough water (money), \u00a0so the government gardeners might walk away or water less.<\/p>\n That means the job of growing this garden\u2014making sure these new ways keep improving\u2014might fall to private gardeners: \u00a0drug companies, \u00a0charities, \u00a0and donors.<\/p>\n But not all of them care about the same plants. Some want to grow what makes them the most money. \u00a0Some may care deeply. \u00a0Others might not help at all.<\/p>\n So the question becomes:\u00a0 If the public gardeners walk away, \u00a0will the private gardeners grow a safe, `healthy garden\u2014or just the plants they profit from?<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n There is a governance and risk-shifting issue that lies at the heart of U.S. biomedical research policy during fiscal contraction.<\/p>\n Non-animal research methods represent public goods:\u00a0 knowledge-generating tools whose benefits are widespread, \u00a0but whose development costs are front-loaded, \u00a0uncertain, \u00a0and often slow to generate profit.<\/p>\n Historically, these have been subsidized by public-sector investment.<\/p>\n With U.S. federal budget cuts, \u00a0particularly in a climate of bipartisan pressure to reduce deficits, \u00a0we are seeing:<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n This creates new risk dynamics:<\/p>\n Also involved is implicitly asking whether this risk shift undermines the moral and scientific case for non-animal methods\u2014which was originally rooted in collective responsibility for ethical science.<\/p>\n If the public sector retreats, we may see not only the failure of non-animal methods per se,\u00a0 but a fragmentation of purpose, \u00a0slowing of systemic change, \u00a0and inequality in what gets developed.<\/p>\n The ethical governance of science\u2014once a public trust\u2014risks becoming a competitive asset class.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n The budget cuts initiated by the Donald Trump administration, \u00a0with support from Elon Musk\u2019s Department of Government Efficiency, \u00a0are poised to significantly alter the landscape of laboratory animal use and the development of non-animal research methods in the United States.<\/p>\n These cuts, \u00a0particularly the reduction of indirect cost funding from the National Institutes of Health, \u00a0have sparked widespread concern among researchers and institutions.<\/p>\n (Beth Clifton collage)<\/strong><\/em><\/p>\n<\/div>\n The NIH\u2019s decision to cap indirect cost reimbursements at 15%\u2014down from previous rates that often exceeded 50%\u2014has placed immense financial strain on research institutions.<\/p>\n These indirect costs are crucial for maintaining animal research facilities, \u00a0covering expenses such as housing, \u00a0care, and compliance with regulatory standards.<\/p>\n Without adequate funding, institutions may be forced to euthanize animals or halt ongoing studies, disrupting critical research efforts.<\/p>\n Already these cuts have led to significant job losses and the suspension of various research programs, \u00a0including those related to COVID-19.<\/p>\n The sudden financial shortfall has left many laboratories unable to sustain their animal populations, \u00a0leading to ethical and logistic challenges.<\/p>\nThere are ways to cut back on lab animal use,\u00a0 but just cutting science budgets is not one of them<\/em><\/span><\/h2>\n
by Morgan V. Sage<\/strong><\/h3>\n
<\/a><\/p>\nThe 3Rs framework &<\/strong><\/span> policy context<\/strong><\/span><\/h2>\n
<\/a><\/p>\nCurrent initiatives & funding landscape<\/strong><\/span><\/h2>\n
<\/a><\/p>\nMoney talks<\/span><\/h2>\n
<\/a><\/p>\nBut most biomedical research remains animal-based<\/h2>\n
<\/a><\/p>\nFunding responsibility and trends<\/strong><\/span><\/h2>\n
<\/a><\/p>\n3Rs research is underfunded<\/h2>\n
<\/a><\/p>\nAccountability of public institutions (NIH and others)<\/strong><\/h2>\n
<\/a><\/p>\nMetrics & oversight<\/h2>\n
<\/a><\/p>\nPressure to make NIH more efficient<\/h2>\n
<\/a><\/p>\nMeasuring progress:\u00a0 metrics & outcomes<\/strong><\/h2>\n
\n
<\/a><\/p>\nDivergent perspectives on NIH\u2019s 3Rs initiative<\/strong><\/h2>\n
<\/a><\/p>\nNABR continues to defend animal-based research<\/h2>\n
<\/a><\/p>\nFuture potential & public good considerations<\/strong><\/h2>\n
<\/a><\/p>\nThink of science as a garden<\/h2>\n
<\/a><\/p>\nGovernance & risk-shifting<\/h2>\n
\n
<\/a><\/p>\nNew risk dynamics<\/h2>\n
\n
<\/a><\/p>\nBudget cuts<\/h2>\n
<\/a><\/p>\nImpact on laboratory animal use<\/h2>\n