Earlier this week, the National Institutes of Health (NIH) – the world’s largest funder of animal research – announced a policy shift: going forward, all NIH grant applicants will be required to “consider” new approach methodologies (“NAMS”).

Paired with a compelling presentation by NIH Deputy Director Nicole Kleinstreuer, this announcement inspires hope for a cultural shift in biomedical research — one that elevates ethics and finds roots in human biology.

From the NIH’s reimagining of the biomedical research environment to its intent to act as a “testbed for transformative change”, Kleinstreuer laid out a future in which science is not only better for humans — but also more ethical for all.

Kleinstreuer spoke clearly: the NIH wants to replace “outdated” animal “models” with human-biology-based technologies and ensure that, when animal labs close, new animal labs don’t open in their place.

We applaud the NIH’s pronouncements, but we must also remain vigilant – for, not only did NIH Director Bhattacharya just frame animal research as both scientifically justified and “vital”, but, as Kleinstreuer called out herself, the “scientific and regulatory infrastructure” built around animal experimentation “has been entrenched in decades upon decades of historical use”. 

And the animal research industry will not cede its ground willingly.

Though the NIH was clear in its vision of foundationally modernizing science by ensuring that NAMS do not remain “side projects”, its vision was already under threat before Kleinstreuer took to the podium.

As scholar Zaher Nahler recently and explicitly warned, there is a growing trend among industry to frame NAMS – not as replacements for animal research, but – as complements to it. 

And, this strategy directly threatens ethical and scientific progress by allowing the animal research industry to retain its same violent core structure – albeit cloaked in the language of innovation; to retain NAMS as accessories; and to limit NAMS to tools that support – rather than displace – animal research.

“Making NAMS ‘complements’ to animal experimentation is the modern-day Trojan Horse of the animal industrial complex to occupy the NAMS space,” writes Nahler, who cautions that regulators and other industry players are increasingly “polishing” their public image by rebranding NAMS as complements to vivisection.

Put differently, instead of positioning NAMS as challengers to the current system, the industry is trying to position them as add-ons – as tools to be considered alongside animal research, not in place of it.

And, we’ve seen this before: not only does the NIH’s Complement Animal Research in Experimentation (Complement-ARIE) program – described by Kleinstreuer as a “precedent-setting”, “first of its kind” effort to replace vivisection – specifically frame NAMS as “complements” to animal research, but – in the same year that the NIH established Complement-ARIE – it released a separate, official report in which it echoed the talking points of the animal research industry by describing NAMS as augmentations of animal studies.

Unfortunately, part of the challenge here is most foundational, stemming from how regulators (including the NIH) have defined “NAMS”.

Despite what many of us might assume, the NIH is not using NAMS to mean “Non-Animal Methods”. Instead, it defines NAMS as “New Approach Methodologies” – a term so vague and elastic that even animal-derived and animal-based techniques (such as tweaked animal “models”) can qualify – and, indeed, as Nahler highlights, they often do. 

Under this definition, animal exploitation can be – and often has been – counted among “innovative” NAMS; and this means that the very term meant to signal progress toward ethical, human-relevant research can be – and, really, already has been – weaponized to preserve the very system it was supposed to replace.

Among other pitfalls, this risks blurring the line between ethical and unethical science – of bundling all “innovative” or “new” methods together and presenting them as progress, regardless of the harm they cause . . . which is exactly the kind of illusion, or bait-and-switch, that the animal research industry is banking on.

It’s actually one part of the illusion that the industry has come to rely on as calls for reform have grown louder: support NAMS just enough to claim progress, but not enough to disrupt the foundation of animal experimentation. (We recently covered how animal research industry groups like Americans for Medical Progress (AMP) publicly voice support for NAMS while privately fighting to keep animals at the center of U.S. biomedical research.)

This tells us clearly that we need more than the consideration of NAMS; we need their prioritization, implementation, and use. 

The NIH’s new requirement that grant applicants “consider” NAMS is certainly welcome, but experience warns us about just how hollow it could become in practice:

For decades, research facilities funded by the NIH and/or regulated by the USDA have been required to maintain Institutional Animal Care and Use Committees (IACUCs); and these committees have been tasked with ensuring that researchers consider “alternatives” to animal use before conducting experiments. In practice, though, this requirement has translated into little more than the requirement that researchers check a box on a form – something that, unsurprisingly, has failed to either reduce animal use or shift the research culture in any meaningful way.

So, while “consideration” may signal the beginning of change, it is far from a guarantee; and very real risk remains that NAMS will not be welcomed in to displace animal research, but, rather, be folded into the existing system built on animal exploitation.

Writes even pharmaceutical industry insider Drug Discovery and Development:

The specific wording of the NIH policy stops short of mandating alternative preclinical testing. And thus, the prohibition on proposals exclusively using animal models creates a potential loophole: a research plan could still be overwhelmingly based on animal studies, as long as a minor NAM component is included to satisfy the requirement.

That’s one reason this moment demands our full attention.

We must both commend the NIH’s espoused intent and guard against the animal research industry’s efforts to package NAMS alongside animal research – against the industry being allowed to treat NAMS as supportive tools rather than directives for change and disruptors of exploitation.

Indeed, as Nahler reminds us:

It is imperative for governmental agencies in the U.S. and abroad, as part of purging ‘Group Think’ and ridding themselves of industry capture, to be deliberate in the way they advertise and present their signature programs on NAMs.

We must demand that regulators and industry:

• Accept NAMS as “freestanding, human-relevant models that [] constitute the core of 21st-century experimental designs for studying serious diseases”;

• Recognize NAMS as “non-animal methods” – not methods that exploit and harm animals in “newer” or different ways; and

• Use NAMS, not *just* consider them.

Your call to action: Support the SPARE Act to end wasteful, taxpayer-funded animal research.

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