In mid-2016, as a federal moratorium still loomed over risky biomedical research, an ad hoc review committee of National Institutes of Health scientists stood as the first line of defense, tasked with determining whether U.S.-funded projects were pursuing science deemed too dangerous to fund.
When a proposal to perform experiments on high-risk coronaviruses at the Wuhan Institute of Virology landed before the group for review, its members quietly debated concerns about the need for stricter scrutiny. They ultimately relied on assumptions and sidestepped deeper checks into whether further safeguards were necessary, allowing the proposed research to slide by.
Recently obtained government emails for the first time lay bare the NIH “gain-of-function” review committee’s informal vetting of the controversial project, demonstrating the agency’s weak oversight of the potentially dangerous research it funded at the lab where some critics believe the pandemic started.
The proposal, submitted by the New York-based nonprofit EcoHealth Alliance, sought to test potentially dangerous coronaviruses by constructing chimeras – mutants spliced together from fragments of two or more viruses. And, they aimed to perform the experiments at the Chinese lab with no direct American oversight, raising questions about potential biosafety risks.
Although these experiments called for manipulating wild bat strains of viruses similar to SARS and MERS — pathogens restricted under the federal moratorium — they were deemed “technically not covered” by it, one committee concluded after reading the proposal.
Another member surmised that extra scrutiny probably wasn’t necessary, even though the plans aimed to construct a new strain using a SARS gene that plays a key role in making that virus more infectious to humans. As a pathogen listed by the federal government as a restricted “select agent,” experiments with SARS typically require additional approvals from an outside agency.
“If this is just one gene…,” the member wrote, “then (it) should be OK.”
Details about the review committee’s internal deliberations, which have not been previously reported, come amid renewed congressional investigations and ongoing regulatory reforms on federally-funded risky research projects. They were revealed in the latest emails and documents released to U.S. Right to Know under an ongoing federal Freedom of Information Act lawsuit against the NIH.
‘documents the public urgently needs to see’
Bryce Nickels, a professor of genetics at Rutgers University and critic of gain-of-function research, called the documents “depressing” after reviewing them.
“These are documents the public urgently needs to see because they highlight why past policies failed,” he said. “Unless we learn from the policy failures of the past and establish policies with independent oversight and public transparency, we risk yet another lab-generated pandemic.”
The committee’s informal deliberations over the proposed experiments came after EcoHealth revealed in a month-late progress report and follow-up letter that its Chinese collaborators had already constructed two chimeric viruses nine months earlier without first informing the agency, the records show.
“Surely, such experiments should have been subject to detailed scrutiny BEFORE construction of the infectious clones,” said Steve Massey, a University of Puerto Rico bioinformatics professor who reviewed the emails.
The lab work that created the chimeras took place in Wuhan in September 2015 under EcoHealth’s NIH-funded project studying coronavirus risks, records show. It involved splicing together fragments from different wild bat coronavirus strains that were genetically similar to the Severe Acute Respiratory Syndrome (SARS) virus that killed nearly 800 people more than a decade earlier.
When EcoHealth officials revealed in a May 2016 progress report that their Chinese collaborators already had constructed the SARS-like chimeras, they proposed carrying out a series of infectivity experiments with the new viruses. They also proposed constructing additional chimeric strains by inserting fragments of different bat coronaviruses into infectious clones of another pathogen, Middle East Respiratory Syndrome (MERS), and then testing their ability to infect animal and human cells.
NIH managers overseeing the grant flagged the proposed experiments to be reviewed by scientists on the agency’s ad hoc committee tasked with determining whether potentially risky studies amounted to “gain-of-function” research. At the time, such research – which involves altering pathogens to make them more infectious or transmissible to other species – was barred from federal funding under a moratorium imposed by the Obama White House two years earlier. The funding pause specifically applied to gain-of-function experiments with influenza, MERS and SARS viruses.
The grant managers and the review committee ultimately decided EcoHealth’s research wasn’t subject to the pause, largely relying on the nonprofit’s own assurances and the Wuhan Institute of Virology’s international reputation to greenlight the experiments and skip additional formal reviews. Some committee members also wrongly assumed at the time that the experiments wouldn’t enhance viral infectivity and would be conducted in labs equipped to contain high-risk pathogens, the emails show.
The NIH media office under the current Trump Administration did not respond to U.S. Right To Know’s requests for comment about the new details, or to requests to interview some of the committee members who still work at the agency. (See editor’s note with NIH comments at bottom of story.)
Peter Daszak, EcoHealth’s former director who has since been barred from receiving federal research funding, also did not respond to an interview request to discuss the records.
The then-proposed experiments detailed in the records – involving manipulating bat coronavirus strains to test their transmissibility in mice with human genes – did not create SARS-CoV-2. Analyses have since shown the viruses involved in these experiments are too genetically different to have spawned the strain that caused the pandemic. But the research later became the subject of intense controversy and congressional investigations.
Critics contended the NIH should never have funded such risky research, let alone at the Wuhan lab – the site from which some believe the virus that spawned the pandemic escaped. Neither the lab leak hypothesis nor the hypothesis that virus spilled over naturally from animal to humans has been proven.
Following the pandemic’s outbreak, Daszak and Anthony Fauci, who headed the NIH’s National Institutes of Allergies and Infectious Diseases (NIAID) at the time, separately testified to Congress that the experiments did not meet the the agency’s definition for gain-of-function research that was subject to the moratorium.
But some of the hybrid coronaviruses that were constructed at the Wuhan lab were later shown to increase pathogenicity and infectivity in mice genetically-modified to have some human genes, prompting some scientists, politicians and other critics to dispute their testimony as false.
The latest emails provide the most details to date about the internal deliberations of the NIH committee, which provided guidance for determining which proposals amounted to gain-of-function research during the White House moratorium from October 2014 until 2017, when a new regulatory framework was implemented.
The informal group – made up of several scientists who served in top branch or division management roles under Fauci – was responsible for ensuring that NIH-backed research wasn’t taking unnecessary risks with infectious agents that could endanger the world.
The exchanges reveal the agency’s lax approach in assessing how policies regulating risky studies at the time applied to cutting-edge research on bat coronaviruses – including newly discovered strains that hadn’t been fully assessed – in the years before the pandemic exploded. They demonstrate that officials recognized the proposed experiments crossed into some gray zones but nonetheless allowed the research to proceed.
Questions, loopholes and gray zones
Questions over the research arose in May 2016, the emails show, after EcoHealth submitted its second year progress report to NIH under a five-year grant for a project dubbed, “Understanding the risk of bat coronavirus emergence.”
The report, submitted a month after its original deadline, revealed that EcoHealth’s Chinese partners had already constructed two chimeric SARS-like viruses. EcoHealth then proposed to test the infectivity of those chimeric strains, which their Chinese collaborators had constructed by inserting genes from two newly discovered SARS-like viruses into the backbone, or core structure, of another called WIV-1.
The nonprofit also sought to engineer chimeric MERS-like viruses by inserting different wild bat strain spike proteins — a feature that enables the viruses to penetrate and infect host cells — into an infectious clone of MERS that would be engineered in the lab. All of the new work would involve testing the potential infectivity of the mutant MERS-like and SARS-like strains on a variety of animal cells and in mice modified with human genes, according to paperwork submitted by EcoHealth. Dr. Zhengli Shi, the renowned Chinese coronavirus researcher known as the “bat lady,” would lead the experiments in a biosafety level 3 (BSL-3) lab designed to handle dangerous biological agents.
At the time, the White House moratorium explicitly barred federal agencies from funding studies that were anticipated to enhance the pathogenicity or transmissibility of influenza, MERS, or SARS viruses in mammals.
The newly proposed work and revelations about the previously constructed chimeras, drew questions from NIAID program officer Erik Stemmy and grants management specialist Jenny Greer, who oversaw Ecohealth’s grant and were responsible for ensuring it complied with the moratorium.
On June 8, 2016, Daszak disclosed in a response letter that the chimeras had been constructed nine months earlier, in September 2015, by combining WIV-1 clones with fragments from two newly discovered coronaviruses that he acknowledged might have spawned SARS, the pathogen that emerged in China in 2002 and killed nearly 800 people. But because the work involved only creating “SARS-like” viruses – not SARS – Daszak contended that researchers felt it “is not subject to the pause.”
He also noted that the primary viral strain used for the chimeras, WIV-1, “has never been demonstrated to infect humans or cause human diseases.”
Daszak cited a 2015 study headed by University of North Carolina (UNC) virologist Ralph Baric that found SARS became less infectious when combined with a WIV-1 spike gene, writing that the research “strongly suggests” that the new chimeric viruses “should not have enhanced pathogenicity in animals.”
Although Daszak’s letter also cited another study published by Baric’s team just three months earlier, he didn’t explicitly point out that researchers concluded the WIV-1 coronavirus cluster “has the ability to directly infect and may undergo limited transmission in human populations.” Nor did he mention that a spike gene inserted into one of the EcoHealth chimeras came from SHC014 – a novel SARS-like coronavirus that Baric also had used to infect human cells in the study published in 2015. Daszak told Nature magazine at the time that Baric’s findings on SHC014 “move this virus from a candidate emerging pathogen to a clear and present danger.”
EcoHealth’s letter to NIH also downplayed the potential risks of the proposed MERS-like chimeras, contending they were so molecularly distant from the known deadly strain of MERS — a coronavirus with a case-fatality of about 35 percent — that it would be “highly unlikely” that they “would have any pathogenic potential.”
To address safety concerns for the proposed work, Daszak pledged that if any of the chimeric strains showed increased pathogenicity, researchers would ”immediately stop all experiments” and notify the NIH.
After reviewing EcoHealth’s response letter, Stemmy flagged an apparent discrepancy: it stated the internal biosafety committee (IBC) at UNC used by Baric would serve as the oversight body for the experiments, even though the work was proposed to take place at the Wuhan lab. Stemmy emailed Daszak for an explanation.
“Can you clarify where this work will actually be performed,” Stemmy asked.
Daszak replied that oversight for the project would come from the IBC at the Wuhan lab, saying the reference to UNC was “a clerical error.” And, as the project’s principal investigator, Daszak assured Stemmy he would immediately be notified should researchers observe enhanced growth in any of the chimeric viruses – and, in turn, he would notify NIAID.
In a June 30, 2016 email, Stemmy recapped the proposed work and relayed Daszak’s assurances to more than a dozen of his NIH colleagues on the review committee, asking the group to share “any concerns.”
Five days later, after he sent a reminder email to the group, Linda Lambert, chief of the Respiratory Diseases Branch at NIAID’s Division of Microbiology and Infectious Diseases, responded directly to Stemmy that she’d read Daszak’s response letter and agreed that the SARS-like clones were “technically not covered by the pause.”
She also wrote that while she believed the proposed MERS experiments were “where the potential for GoF (gain-of-function) lies,” she believed Daszak had “all the right stoppages in place if he sees increased” pathogenicity or transmissibility.
Lambert then emailed the full group: “Read Daszak’s response. Good to see the correction that it will be the Wuhan IBC where the work will be done/IBC oversight. No further comments from me…”
A series of replies followed, rubber-stamping her sentiments.
“I don’t have any concerns,” emailed Teresa Hauguel, a program officer for the respiratory diseases branch.
“I do not have any concerns either,” wrote David Spiro, chief of the branch’s Viral Respiratory Diseases section.
“Concur,” added Irene Glowinski, the deputy director of NIAID’s Division of Microbiology and Infectious Diseases.
But the next day, Glowinski had second thoughts: “Is any of our money going to China,” she asked in an email to Stemmy.
He replied, “most of the budget for this award goes to China,” noting that about $160,000 would go to the Wuhan lab over each of the last three years of the grant.
With no further immediate feedback, Stemmy and Greer, the grant manager, finalized the NIH letter determining EcoHealth’s experiments proposed for the Wuhan lab were not subject to the White House pause.
On July 7, Greer emailed the nonprofit a formal letter with language that parroted the same assurances Daszak had previously given them — that if researchers encountered the unanticipated outcomes of tenfold viral growth, all experiments would immediately be stopped and NIAID and the Wuhan lab’s biosafety committee notified.
But after the letter was sent, Glowinski’s questions still lingered, records show. She wondered whether the experiments required validation that the foreign lab was operating at biosafety level 3 (BSL-3) – one of the highest safety levels for certain risky research involving potential pathogens. She emailed Stemmy: “If we are sending money to China, wouldn’t their BSL-3 facility have to be `approved’ through …our process for international research via DEA (Division of Extramural Activities)? Has that already happened?”
Before responding to her, Stemmy emailed another program officer, asking: “Are there other approvals we need for BSL3 work?”
The program officer replied that if the proposed research didn’t involve a designated “select agent,” she didn’t believe any other approvals were necessary. But, she added: “You may want to clarify that point – that there is no select agent work being done.”
The Federal Select Agent Program – jointly managed by the Centers for Disease Control and Prevention and the Department of Agriculture – restricts experimentation with certain biological agents and toxins that pose threats to humans and animals. While neither MERS nor WIV-1 were listed as select agents that required labs to get special approvals prior to experimentation, the SARS virus was.
Stemmy emailed Glowinski the next morning. “This award doesn’t have select agent work involved, just MERS and now chimeric WIV-1 with SARS S gene,” he wrote, noting that EcoHealth’s original application didn’t state any biohazard concerns. “Is there additional review needed for non-select agent BSL3 work?”
Stemmy also pointed out that the Wuhan lab “is a major virology center” that housed not only BSL3 labs, but China’s first lab operating at BSL4 — the highest biosafety level. “They’re also a WHO collaborating center,” he added.
Still not satisfied, Glowinski forwarded Stemmy’s message to Dennis Dixon, chief of NIAID’s Bacteriology and Mycology Branch, asking for his input.
“Is this technically a MERS-SARS chimera?” Dixon asked. “If so, I might need to check with the CDC SAP (Select Agent Program) to see if they would hold the work to SARS standards. Any Select Agent-Non Select Agent chimera would be viewed that way.”
And if that were the case, Dixon continued, EcoHealth would need the select agent program’s approval, which is “not simple.”
“If not, then I think that anyone receiving our funds needs to adhere to our guidance for working with BSL3 agents,” Dixon added.
Stemmy replied that the proposed MERS chimeras wouldn’t include SARS fragments, but the WIV-1 chimeras featured a SARS spike gene. “Would the SA (select agent) rules apply for a single gene from a select agent?” Stemmy asked.
“If this is just one gene and it is not the sole basis for the pathology,” Dixon responded, “then should be OK.”
With that, the questions stopped.
They shouldn’t have, Massey said. As SARS-CoV-2 later proved, even a single modification to a spike protein “can create a pandemic pathogen, so this rationale is flawed.”
The review team allowed the experiments to proceed, however, without checking with the CDC about the select agent issue or seeking other formal risk assessments under the agency’s biosafety guidelines or the Dual Use Research of Concern policy that regulated federally funded experiments that might increase a pathogenic agent’s infectiousness.
A few days later, in response to the letter from Greer greenlighting the project, Daszak emailed: “This is terrific! We are very happy to hear our Gain of Function spending pause has been lifted.”
New guidelines
Ultimately, NIH’s determination that EcoHealth’s experiments in the Wuhan lab likely wouldn’t increase pathogenicity or transmissibility in the SARS-like chimeras turned out to be wrong.
In its Year 5 progress report, EcoHealth revealed that one of the SARS-like chimeras became far more infectious in mice modified with human genes than the original WIV-1 virus did, and, at certain times during the experiment, exceeded the NIH’s restricted levels.
Under the terms of Greer’s approval letter, the “substantial growth required immediate reporting and cessation of the experiment,” said Massey, the bioinformatics professor who reviewed the records. “They apparently failed to do this.”
“My conclusion is that the people making the assessments didn’t have the necessary scientific background to be able to adequately scrutinize Daszak’s scientific claims, which were spurious.” Massey added.
One of the committee’s most significant oversight decisions, Massey said, was Dixon’s assumption that the SARS-like chimeras weren’t subject to select agent rules. Once that conclusion was drawn, he noted, Glowinski’s concerns about whether the NIH should validate the Wuhan lab’s biosafety level for such experiments dissipated.
But papers published in 2016 and 2017 under NIH-funded grants to EcoHealth show researchers at the WIV have performed other experiments with live SARS-like viruses under BSL2 conditions — a biosafety level for moderate-risk agents that U.S. lab guidelines and some scientists generally deem insufficient for experiments with potential pathogens and other potentially dangerous exotic viruses, demonstrating that Glowinski’s initial concerns were on point.
And, following the outbreak of the pandemic, top NIH officials worried that the infectivity experiments with mice also had taken place at the WIV in a BSL-2 lab with biosafety standards below what NIH typically approve for such research, according to previously released emails obtained by The Intercept.
Richard Ebright, a Rutgers University professor and vocal critic of gain-of-function research, has said that the newly released emails are significant because they, for the first time, identify members of the NIH committee “who approved the reckless research and allowed it to proceed in clear violation of the Pause.” He added that several of them still appear to be working at the agency.
Ebright added that, in his view, the conclusion drawn by Lambert, in particular — that the White House pause didn’t “technically” apply to EcoHealth’s experiments — represents a “deliberate misrepresentation” of the moratorium, which specifically restricted research with “influenza, MERS and SARS viruses.”
Stemmy, who remains working at the NIH, directed questions for this story to the agency’s media office. It did not respond to a list of written questions before publication. Lambert, Dixon and Glowinski are no longer listed in the agency’s online directory. (See editor’s note with Stemmy’s comments at bottom of story.)
The funding moratorium for gain-of-function research ended in 2017 when the Department of Health and Human Services (HHS) issued new guidance under the Potential Pandemic Pathogen Care and Oversight (P3CO) policy. After that, EcoHealth’s bat coronavirus experiments at the Wuhan lab continued for at least three more years.
Following attempts in 2020 by the Trump Administration to cancel the grant, NIH extended funding until 2024, when HHS suspended the grant due to concerns over EcoHealth’s oversight of the experiments in Wuhan and failure to immediately stop and report research showing the enhanced pathogenicity in mice. Earlier this year, the HHS debarred the nonprofit and Daszak from receiving federal funds for at least five years. The nonprofit later dismissed Daszak and has since dissolved, with Daszak establishing a new group researching coronaviruses.
In the pandemic’s aftermath, newly enacted regulations and guidelines have also since eliminated some gray areas and loopholes encountered by the NIH review team in 2016.
A rule change to the Select Agent Program in 2023 specifically classified some SARS-like chimeras as select agents. In May, Trump also issued an executive order that broadened the definition for gain-of-function, paused federal funding of it in the U.S., and outright banned it in “countries of concern,” including China and other foreign nations deemed to have “insufficient research oversight.”
While it develops new guidelines, the NIH has since directed all of its grant recipients to identify any work that meets the new definition for gain-of-function —“scientific research on an infectious agent or toxin that has the potential to cause disease by enhancing its pathogenicity or increasing its transmissibility.”
But weighing exactly which risky research or gain-of-function projects should be banned or allowed remains unclear. A deadline for the White House Office of Science and Technology Policy to implement new restrictions under the president’s order has passed with no new guidance. The NIH recently announced it has launched a yearlong process to study the issue, with new guidelines now not expected until the fall of next year.
Meanwhile, debates continue over gain-of-function research. Some scientists see value in allowing certain experiments that can improve disease surveillance and contribute to development of vaccines and therapeutics. Others contend the potential for lab accidents and unleashing the next pandemic creates too many risks.
In a podcast discussion in August, acting NIAID Director Jeffery Taubenberger told NIH Director Jay Bhattacharya that making such gain-of-function determinations “is not a simple black-and-white issue.”
“Very reasonable, very well-informed people could fall on opposite sides of the line, wherever you draw the line,” Taubenberger said.
The lack of regulatory urgency and Taubenberger’s public positions on the issue have rankled some biosafety advocates who had hoped the Trump administration would end federal funding of gain-of-function research forever.
(Editor’s note: Update at 12:44 p.m. Sept. 30, 2025: Following publication of this story, the NIH press office emailed responses from Erik Stemmy to written questions posed by U.S. Right To Know, which also provided copies of the 2016 emails with the gain-of-function committee’s deliberations. A full copy of the NIH response email can be found here.)
