Spurred by pandemic, U.S. government will revisit federal policies on risky virus research | Science

In the wake of the coronavirus pandemic, the U.S. government is revisiting its oversight of experiments that involve modifying pathogens in ways that might make them more harmful to people. Yesterday, White House officials and the National Institutes of Health (NIH) asked an expert advisory board to undertake a swift, broad review of the agency’s policies that aim to make sure federally funded studies of viruses and other microbes that could cause a pandemic are undertaken safely, and to bar funding for experiments deemed too risky.

The review—to be conducted over 10 months by the National Science Advisory Board for Biosecurity (NSABB)—could include consideration of whether controversial coronavirus experiments funded by the United States in China should have received stricter scrutiny. The panel might also explore whether the United States should fund any such pathogen research conducted abroad, where NIH may have less ability to enforce its rules.

Researchers who say federal oversight of potentially risky research is too lax are welcoming the review. But some NSABB members and outside scientists worry it could result in recommendations that limit U.S. support for research essential to fighting SARS-CoV-2 and future pandemics.

The goal of the biosecurity policy review is to examine some “challenging questions, including … whether there are some experiments that should not be done because of the risks they pose,” said Daniel Gastfriend, director for biodefense and pandemic preparedness at the White House’s National Security Council, during the online NSABB meeting yesterday.

Some researchers have long worried that pathogens being studied in labs could accidentally escape, or even be deliberately released. They have become particularly concerned about certain gain-of-function (GOF) experiments in which researchers give pathogens new capabilities, such as the ability to spread among mammals, in order to better understand their biology.

In response to such concerns, the U.S. government over the past decade has developed several regulatory systems that impose stricter oversight on research involving especially problematic human and animal pathogens. One set of rules, for example, requires NIH to impose special requirements on studies that involve what NIH defines as enhanced potential pandemic pathogens (ePPPs).

NSABB last met in January 2020, just before the COVID-19 pandemic took off. Its task then was to consider whether closed-door government reviews of certain ePPP studies should become more transparent. At the time, federal officials had approved just two such projects, both involving the H5N1 avian influenza virus. (Both have since ended after the investigators decided not to seek to renew their funding.) NIH then postponed further NSABB meetings so board members could focus on the pandemic.

Public concerns about GOF studies have since exploded, with certain Republican lawmakers, the public, and some scientists suggesting the coronavirus pandemic could have resulted from the escape of a modified virus from the Wuhan Institute of Virology (WIV) in China. The facility received U.S. funding to manipulate bat coronaviruses and the Middle East respiratory syndrome virus, under a subcontract from NIH grantee the EcoHealth Alliance. Critics of NIH argue that work should have fallen under the ePPP definition. (NIH had concluded it did not.)

At yesterday’s 1-hour NSABB meeting, Gastfriend and another White House official told the board that President Joe Biden’s administration plans a broad review of the ePPP and other biosecurity policies. Among their questions is whether some experiments are “too risky and/or not needed to be done,” said Andrew Hebbeler, assistant director for health and life sciences in the Office of Science and Technology Policy, who in 2014 oversaw a federal moratorium on funding certain GOF studies.

NIH is particularly interested in whether some studies of “wild-type” pathogens—such as animal or human viruses found in nature that have not been modified—should qualify as ePPP research, said NIH acting Director Lawrence Tabak in issuing the committee’s charge. The agency also wants NSABB to consider whether the ePPP scope should include certain experiments using “animal models of transmissibility,” and examine “considerations” for funding ePPP studies internationally. That last point appears to refer directly to the NIH-funded WIV studies.

NSABB will also look at the scope and effectiveness of policies covering what is known as dual-use research of concern. Those policies, which cover pathogen research that could produce a bioweapon, sometimes overlap with GOF and ePPP rules. NSABB will explore ways to merge the disparate rules, with a draft report due by December.

Some critics of NIH’s ePPP policy are pleased with NSABB’s new charge. The current policy “leaves all kinds of loopholes,” says Filippa Lentzos, a social scientist and biosafety expert at King’s College London. “We need a [ePPP] definition that … covers high-risk research generally, not just a small part of it.”

But others, including some NSABB members, worry the review’s tight timeline will lead to recommendations to impose overly restrictive rules. “We’re just coming through a devastating pandemic and we don’t understand the biology” of SARS-CoV-2, said virologist Mark Denison of Vanderbilt University. He called for “time for scientists to really talk about how science is performed and how we really want to do this right.”

NSABB member Kenneth Bernard, a retired U.S. Navy rear admiral, physician, and biodefense expert, worried overly strict rules could prompt researchers to move their experiments to nations with less stringent oversight. “I can’t emphasize too much … how important it is to not be the only place in the world where [pathogen] research is too hard to do,” Barnard said. “And I’m a national security guy.”