A New Gain-of-Function Research Policy
…computational (i.e., in silico) research that may include development of computational models…to design novel forms of biological agents, is not prohibited.
—“United States Government Policy for Stopping High-Risk Life Sciences Research,” July 20, 2026
…for the first time, an explicit prohibition on dangerous gain-of-function research.
—”U.S. Government Policy for Stopping High-Risk Life Sciences Research,” statement of Jay Bhattacharya (NIH Director), July 28, 2026
Last month the federal government announced a replacement of the old regime for funding and oversight of potentially risky gain-of-function and other biological research. A “paradigm shift in federal oversight” in their telling.
Welcome to the Main Event
The mostly hysterical takes on the recent Rand Paul v. Anthony Fauci (Round ??) reminded me of something I completely forgot.
At that same committee in 2019, we sat down with representatives from NIH and other federal offices1 to discuss policies around federal funding for gain-of-function research (GOFR). Those policies were collectively called Potential Pandemic Pathogen Care and Oversight (P3CO), which is what the Trump admin replaced.
A brief timeline leading to today is below, but the proximate concern at the time was the status of and compliance with the government's GOFR policy.
To this day I don't hold a categorical position on this, and certainly didn’t then. As I understood, GOFR is an avenue of inquiry that presents risks and has also provided useful epidemiological and medical insights.2
So how did we get here?
TIMELINE
2014 — Government safety failures.
~62 CDC employees potentially exposed to live anthrax after a scientist used an unnecessarily dangerous strain and an unapproved inactivation method, caught only because a broken autoclave left samples incubating long enough for someone to notice bacteria growing.
A benign flu sample cross-contaminated with H5N1 and shipped out (caught by USDA).
Smallpox vials from 1954 left forgotten at NIH, two of six still live.
2014–2017 — The response.
Epidemiologist Marc Lipsitch (then of Harvard School of Public Health) forms the Cambridge Working Group, made up of hundreds of scientists, and calls for reconsidering research that results in “potential pandemic pathogens.”
NIH issues funding moratorium, and the government spends three years on the broader question: two National Academies symposia and 1,000-page risk-benefit analysis.
Conclusion (December 2017): benefits outweighed risks and moratorium replaced with case-by-case federal review (P3CO).
2019 — The first new grant approval.
Lipsitch and Tom Inglesby (Johns Hopkins School of Public Health) argue the government is funding unjustifiably risky research, and doing so in a non-transparent way.
2020–2024 — COVID-19.
Possibility that the pathogenic cause was (1) result of category of research that was subject of US’s P3CO policy and (2) passed from lab containment into wider population.
2024 federal policy on dual-use research and “pathogens with enhanced pandemic potential” tightened at the margin, using existing P3CO-style framework.
2026 — Moratorium → New Policy (July)
Categorically prohibits federal funding for research meeting a “dangerous gain-of-function” (DGOF) definition
“Potential DGOF” research can still be funded, but only after review by a new" “government-wide independent third-party review body” (ITPRB).
Definitions/application changes, but replaces one “Review Group” with a “Review Body”
To the degree anything did, what went wrong with the P3CO in 2019-20? Our conversation with the Executive Branch officials was less about whether unacceptable risks were being undertaken by the federal government, than how the government was making such determinations.
Lipsitch/Inglesby had two criticisms: (1) a prudential one about the actual funded research itself; and (2) a procedural one about the anonymous and opaque nature of the funding review.
The core of our 2019 inquiry was about the second complaint, about whether de facto policy deviated from prior practice without public notice. To the degree we could tell, the criteria for review remained unchanged but of course anonymity didn’t help.
Remember, Lipsitch /Inglesby are not crank subreddit lurkers. They had in fact convened the most credible and transparent assemblage of experts on this topic, and the resulting government policy was significantly informed by their recommendations.
Whatever the justifiability of the policy regime, its structure ensured there was no broad constituency invested in defending it. And when an outbreak had even the appearance of a policy failure, the reaction was never going to be proportionate.
An anonymous, expert-only body was making a societal risk tradeoff on the public’s behalf without the public in the room. Expert consensus bought scientific credibility; it never bought durable political legitimacy.
Policy advocates, especially those who believe they have identified the proper structural and institutional design would benefit from humility and an intense study of political economy.3
What to make of it?
The new policy establishes an Independent Third-Party Review Body. All reporting and my review of the policy statement indicates the body will be made up of federal agency officials, though I’m unclear if that’s explicitly binding. But…
A government advisory body → made up of government employees
≠
independent or third-party review
so this nomenclature is internally contradictory. It’s making me verklempt.
The quality of the criteria is important, but should anything go wrong, it won’t protect you from full on public outcry. Transparency, of the reviewers and reviews, is a necessary condition. It may still be insufficient, but without it you’re already cooked.
What’s AI got to do with it?
Let’s clarify: I’m not predicting a SARS-COVID-19 scale AI “lab leak” (or whatever the wet market equivalent is). I’m not a catastrophist but I suppose it’s possible.
But secret White House AI cybersecurity evaluation ain’t helping political durability. It’s sustainable until something goes wrong. Something moderately disruptive, like say a medium-sized municipal water system shutdown. Something that makes the risk salient, the cause of which the public will incorrectly overdetermine, even if it stays shy of DEFCON 3 level freakout.
Because without the feeling of being in the room, the public will reject whatever results. Regulations can only instill confidence if people think they exist.
In 1979, Three Mile Island Reactor 2 overheated. Public support for nuclear energy collapsed and the U.S. spent 40+ years debating whether to try again. Before you think that reaction could happen anywhere, France’s robust regulatory regime managed to support ongoing nuclear energy infrastructure that whole time.
Whatever ought to be the right level of risky bio-research, AI frontier capability, or quantum-something, it won’t matter unless you get public buy-in.
The author is nonresident senior fellow at FAI
Avoiding being too specific to avoid blowing up anyone’s spot. The point here isn’t to call anyone out, and it wouldn’t be any bold-faced names you’d know anyway.
An implicit premise here is that the “lab leak hypothesis” is exactly that, a hypothesis. Not being an expert on this stuff, I’m choosing to just put [gesticulates wildly] all of that aside.
And no, just invoking the words “Elinor Ostrom” in your marketing materials does not magically immunize you from this requirement. Not the least of which because I’m not convinced you’ve actually read her.