The Trump Administration Misses Key Deadlines for Imposing Restrictions on Gain-of-Function Research
Biosafety advocates worry the administration is backtracking on its promise to implement meaningful restrictions on the type of research that likely caused the COVID-19 pandemic.
Biosafety hawks were initially optimistic that the incoming second Trump administration would at last place binding constraints on so-called "dangerous gain-of-function" research, in which pathogens are manipulated in laboratories to be more virulent or transmissible in humans.
The administration's picks for top health policy jobs—most notably National Institutes of Health (NIH) Director Jay Bhattacharya and Health and Human Services Secretary Robert F. Kennedy Jr.—are both gain-of-function critics who have asserted that this type of research created SARS-COV-2 in Wuhan, China.
In May, the White House issued an executive order creating a broader definition for dangerous gain-of-function research and promising that new restrictions on it would be issued within a few months.
"The conduct of this research does not protect us from pandemics. There's always a danger that in doing this research, it might leak out by accident even and cause a pandemic," said Bhattacharya at the Oval Office press conference when the order was signed. With the order, "the public can say 'no, don't take this risk.'"
But the deadlines for the new restrictions called for in that order have since come and gone without any new policy being released. Meanwhile, there are indications that the NIH is continuing to fund risky virological research.
Gain-of-function critics who were optimistic that this research would finally be put back in the box are now concerned that the Trump administration will fail to implement meaningful restrictions.
"There was a promise to deliver these policies. It's very disappointing to see that not emerge," Bryce Nickels, a professor of genetics at Rutgers University, tells Reason. Nickels briefly served as a contractor advising the NIH on new gain-of-function policy before being let go in August.
In his role as an NIH contractor, Nickels reviewed draft policies on gain-of-function research that the May executive order called for. He said that there was no practical reason why the White House shouldn't have been able to meet its deadline to issue the new policy.
The White House's Office of Science and Technology Policy (OSTP), which is responsible for issuing the new gain-of-function regulations called for in the May executive order, did not respond to Reason's request for comment.
While arguments about COVID-19's origins have polarized discussions about gain-of-function research, fears that it could cause a pandemic via a laboratory accident were once mainstream.
The past three presidential administrations issued policies imposing some restrictions on it. That included the 2014 "pause" on gain-of-function research involving MERS, SARS, and influenza viruses issued by the Obama administration.
This was followed by the implementation of a 2017 framework in the first Trump administration that allowed funding for gain-of-function research to start again, provided that the riskiest experiments received risk-benefit vetting by a department-level panel within HHS.
Finally, in 2024, the Biden administration issued a new framework on "dual-use research of concern" that was supposed to clarify when experiments involving enhanced pathogens of pandemic potential should receive that HHS-level review.
Critics have long argued that these policies failed to actually restrict the most dangerous gain-of-function experiments.
Even under the 2014 pause, the NIH, through its subsidiary the National Institute for Allergy and Infectious Diseases (NIAID), continued to fund gain-of-function research on SARS-like coronaviruses at the Wuhan Institute of Virology.
After the 2017 policy went into effect, those experiments were also never vetted by the HHS panel that should have reviewed them. That panel only ever reviewed a handful of experiments and allowed almost all of them to proceed without any modification.
While the 2024 Biden administration policy attempted to clarify which experiments should receive additional department-level vetting, it still left funding agencies like the NIH in charge of deciding which experiments actually qualified for that tougher scrutiny. In January, the Trump administration suspended the Biden administration's policy before it ever went into effect.
Establishing independent, public oversight of gain-of-function research outside of the department that funds them, which biosafety advocates say is ideal, would require congressional action.
The Trump administration's May executive order proposed to do what it could unilaterally by establishing a clearer, broader definition of dangerous gain-of-function research, ending funding for such experiments in "countries of concern" like China, and directing HHS to suspend ongoing gain-of-function experiments until a new, more permanent policy could be issued.
Two days after the White House order, the NIH—the primary funder of life science research—issued a notice that it would not consider new grant awards meeting the new definition of dangerous gain-of-function research. This was followed in June by another NIH notice saying that it would suspend existing grant awards for existing research meeting this definition as well.
That initial order proved somewhat divisive among critics of gain-of-function research.
Richard Ebright, a molecular biologist at Rutgers University and an arch-critic of gain-of-function research, praised it at the time as a "major step" toward restricting this type of research at the time, in an email to Reason.
Others were disappointed that it did not immediately ban federal funding for research meeting the White House's new definition of dangerous gain-of-function research, as an earlier draft of the order had reportedly proposed to do.
Concerns were also raised that Jeffery Taubenberger, a longtime proponent of gain-of-function research, had been appointed to lead NIAID.
These initial concerns were inflamed in July, when the NIH announced that it was suspending funding for 40 experiments pursuant to its June notice. That list was widely panned, including by gain-of-function critics, for suspending grants for projects involving bacterial and fungal pathogens that posed minimal risk to the public and arguably did not even meet the White House's definition of dangerous gain-of-function research.
Meanwhile, almost no projects involving virological research were included on this list.
"What clearly happened was that the program officers assigned to virology simply nullified the executive order, nullified the NIH notification by failing to report the dangerous gain-of-function projects in their portfolio. Even the most glaringly obvious projects were not included on the list," says Ebright.
He says there are dozens of ongoing projects involving SARS, MERS, and Avian flu viruses that meet the White House's new definition of dangerous gain-of-function research that should have been terminated but weren't.
Personnel who were brought on to advise the NIH on gain-of-function restrictions, including Nickels and Edward Hammond, were let go in August. Hammond said on X that he was terminated at the request of the White House but that he had intended to resign because of concerns about the direction of gain-of-function policy.
I was fired at the request of the White House. The reason is withheld from me, but is "not performance related". It's a bit academic because I intended to resign, the substance mainly being concerns over the federal GOF policy, & I had initiated admin talks to do so at August end https://t.co/a7r06DxsaR
— Edward Hammond (@pricklyresearch) August 22, 2025
The Daily Caller's Emily Kopp reports that the list notably did not include gain-of-function experiments on MERS viruses being carried out by University of North Carolina virologist Ralph Baric—a pioneer of gain-of-function research who has collaborated with the Wuhan Institute for Virology.
In a late August article, as the deadline for the OSTP to issue its final policy on dangerous gain-of-function research, Kopp cited three anonymous government sources saying that the NIH was planning to continue novel pandemic viruses.
In a statement posted to X, the NIH dismissed Kopp's story as "factually inaccurate." It said that Bhattacharya's priorities were fully in line with the administration's May executive order and that Taubenberger would play no role in directing dangerous gain-of-function research policy.
The recent Daily Caller story is factually incorrect. NIH has been a strong supporter of the Executive Order and the President, and we will continue to be. Policy development is led by OSTP, with NIH and other agencies providing input and guidance.
NIH is now under the…
— NIH (@NIH) September 2, 2025
As Kopp noted in a X post, the NIH's assertion that Taubenberger would play no role in directing dangerous gain-of-function research policy contradicts a prior statement they gave her saying that he would "lead reforms at NIAID that strengthen biosafety [and] prohibit dangerous gain-of-function research."
A few things:
- NIH appears to be preemptively passing the buck to OSTP if the gain-of-function policy falls short of MAHA's expectations, which it is likely to per my reporting. This is deceptive. NIH (NIAID specifically) oversees the largest portfolio of GOF research.
— Emily Kopp (@emilyakopp) September 2, 2025
The NIH's statement contradicting Kopp's article was issued on September 2, the same day that the White House's May executive order set as a deadline for the OSTP to issue its new policy on dangerous gain-of-function research.
To date, the OSTP has not published that policy. It also blew past an early August deadline to issue a new or revised policy on the transfer of synthetic nucleic acids.
Advocates for those restrictions can only guess as to why the administration is dragging its feet on issuing the new restrictions.
Nickels says that the discussions he was privy to at the NIH mostly hinged on how transparent oversight of potentially risky research would be and whether there would be a process for granting waivers to a ban on dangerous gain-of-function research.
The fights were about "how much does the public get to see and do entities in the government have the ability to bypass the whole process on national security grounds," he tells Reason.
"This, to me, should be focused on protecting the public, not protecting the scientists. That's the perspective I had. That's the perspective that Ed Hammond had. Unfortunately, when both of us were let go, that was lost," he says.
One possible explanation is simply a lack of focus on this issue by the principals identified by the executive order to implement the policy.
In addition to issuing new gain-of-function regulations, the OSTP is tasked with creating the administration policy on AI. Kennedy, who, as HHS secretary, is supposed to work with the OSTP to formulate new restrictions on gain-of-function research, has been embroiled in a number of high-profile controversies related to his other policy initiatives on vaccines and disease prevention.
Ebright says that the policy that should have been published on September 2 wouldn't need to be particularly elaborate. It would need to only involve a reaffirmation and limited clarification of the definition of the dangerous gain-of-function research included in the May executive order. Additional enforcement mechanisms to monitor such research and strip federal funding from institutions whose researchers violate the policy would also need to be clearly laid out.
Ebright speculates that persistent internal opposition at the NIH to the new administration and its policies has encouraged Bhattacharya to be less aggressive in implementing restrictions on gain-of-function research.
"I think it's very possible that what we will see is something limited only to the narrowest part of provisions in the EO, namely, research in China and other countries of concern. That would be a tragic error," he tells Reason. "This research is just as dangerous, just as likely to cause a pandemic, just as likely to kill tens of millions, just as likely to cause tens of trillions in damages if it's performed in the United States."