President Trump is reportedly preparing an executive order to halt funding of risky viral gain-of-function research—lab experimentation designed to genetically manipulate biological agents to make them more transmissible and pathogenic.

Trump is right to do so. Following the COVID-19 pandemic, which killed more than an estimated 15 million globally, the rationale for such a moratorium is stronger than ever. It is highly likely that the deadly SARS-CoV-2 virus originated in the Wuhan Institute of Virology, a prominent Chinese lab and the epicenter of gain of function research on bat coronaviruses.

Current funding restrictions, evident in grant funding for research in China, are clearly inadequate. To address this, President Trump should quickly adopt a variant of President Barack Obama’s 2014 funding moratorium on gain-of-function research.

But that’s not enough. Given well-documented federal failures to effectively monitor risky research grants, as well as the emergence of serious bio-security threats from abroad, there is an urgent need for a comprehensive review and assessment of these experiments, at home and abroad.

Many scientists have long favored such research, arguing that it is necessary to create more pathogenic viruses so we can study their evolution and design vaccines to counter them. Nonetheless, in the interests of public health and safety, Obama wisely imposed the 2014 moratorium following several “biosafety incidents” at federal research facilities and then launched a review to assess the risks and benefits of gain-of-function research.

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The Wuhan Chinese lab was a subcontractor of Eco Health Alliance, a controversial New York-based firm that had long received substantial federal funding, and which, to bipartisan applause, was recently banned from participating in federal research programs.

Moreover, the National Institutes of Health (NIH) also failed to effectively monitor federal grant funding for such overseas research.

The NIH research grant review process also proved dangerously weak. Congressional investigators reported that Dr. Anthony Fauci, the former Director of the National Institute of Allergy and Infectious Disease, repeatedly denied that his agency ever funded any gain-of-function research program in China. And they also reported that Fauci would sign off on federal grants without actually reviewing them.

Beyond COVID-19, there have been other lapses. For example, NIH officials also failed to be transparent about a recent case of gain-of-function research on the MPXV virus, which causes the dangerous disease called Monkeypox. Remarkably, NIH officials misled congressional investigators about the status of that research for approximately 17 months.

We must clear up the confusion. Gain-of-function research has become a flashpoint in the debates over the origin of COVID-19, largely because of federal officials’ inadequate responses to legitimate congressional inquiries.

In its recent report on COVID-19 oversight, the House Select Subcommittee on the Coronavirus Pandemic observed, “Throughout the COVID-19 pandemic many scientists and government officials categorically denied that taxpayer funds were used for gain of function research in Wuhan at the Wuhan Institute of Virology. These assertions rested on semantics and the misapplication of understood definitions.”

NIH officials’ poor performance in responding to congressional inquiries on the topic has further undermined trust among lawmakers and the general public alike. For example, as of October 20, 2021, the NIH website described gain of function as “a type of research that modifies a biological agent so that it confers a new or enhanced activity to that agent.” On that very same day, following a congressional inquiry on the subject, that definition mysteriously disappeared from the agency’s website. Naturally, congressional investigators and the public have every right to be suspicious of NIH officials’ behavior.

The gain-of-function controversy came to a head in 2021. In congressional testimony, Fauci—rather than cite the established NIH definition of these experiments on its website—consistently relied on a separate regulatory definition, the 2017 PC30 Framework, that restricted federal dollars for gain-of-function experimentation to a subset of pathogens that were already dangerous to humans, i.e., “highly transmissible” and “highly virulent” and capable of “wide and uncontrollable spread’ thus inflicting high morbidity and mortality on human populations.

As we have noted previously, this regulatory definition of “gain of function of concern” does not render such viral research less risky under the generic, or non-regulatory, definition of such laboratory experiments. A virus in the wild that is not naturally dangerous to humans—as distinct from the deadly viruses categorized under the PC30 Framework—can be made very lethal to humans by genetically manipulating it and inserting that modified virus into a mammal engrafted with human cell receptors, such as we believe was the case with COVID-19.

The risks of a pandemic are even greater if such lab work is being conducted under substandard safety conditions, which was certainly the case at the Wuhan Institute of Virology. And in China, under the terms of the NIH generic definition, American taxpayers did indeed fund gain-of-function research on bat coronaviruses and using “humanized” mice. Among others, Lawrence Tabak, acting Director of NIH, conceded that such research would fit the traditional, or generic definition of gain-of-function research as initially defined on the NIH website.

Andrew Noymer, professor of public health at the University of California in Irvine, has argued, “ To avoid a repeat of COVID, we need better regulation of gain-of -function virology, and full transparency about coronavirus research in the years leading up to the pandemic.”

While the global COVID-19 pandemic has now unfortunately become endemic, the case for enhanced biosecurity is even more urgent. Today, policymakers should especially be on guard against the threat of a genetic manipulation of the H5NI virus, an avian influenza already dangerous to human beings. H5N1 has rapidly emerged as a major agricultural threat to the poultry and dairy industry affecting both egg and milk production.

Earlier gain-of-function research conducted in Europe figured out how to modify H5N1 so it could now be modified to infect humans by aerosol and droplet transmission. H5N1 has already infected more than 25 mammal species in the US, bird to mammal, however it has not yet learned how to go mammal to mammal.

H5N1 will continue to try to learn how to transmit among mammals. No one knows how long it will take for a natural spillover to occur. That said, in the laboratory with gain-of-function research techniques, this is easily accomplished in weeks. Once the virus is made, the risk of a lab leak will be imminent.

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Next Steps. We must learn from the missteps that led to the COVID-19 pandemic and halt this dangerous research until society can engage in a broader debate to determine its value to protect public health compared to its risk. And, assuming such research can be justified, we need to figure out how best, and under what circumstances, it could be conducted in a safe, effective and responsible way.

In the face of potentially grave threats, the Trump administration should update President Obama’s policy of “pausing” gain-of-function research and go further by renewing a comprehensive assessment of the state of that research. This would at least include the value of that research and its risks and benefits, clarity on the different levels of risk entailed by such research, and the standards and protocols that must govern the permissible conduct of any such research at home and abroad.

Needless to say, any such research should be limited and conducted at the highest levels of laboratory safety in our nation’s most secure laboratories, such as the Centers for Disease Control and Prevention (CDC) or Fort Detrick.

Moreover, given the well documented lapses in the NIH review process, policymakers should also remove final approval of any gain-of function research grants from NIH and, as congressional investigators have recommended, transfer that responsibility to an independent commission. Such a commission should be comprised of top-tier scientific advisors and national-security experts free of any government agency biases or private financial interests.

Congress should also restrict federal and private sector biotechnology investments in China, as recommended by the nonpartisan Commission on China and COVID-19,as well as any other state actor that could pose a bioweapons threat to the United States and its allies.

Biosecurity is one of our country’s greatest national security threats. The incoming Trump administration is right to take urgent action to scrutinize gain of function research. In the process, Trump officials can ensure the public health and safety of millions of Americans, as well as people around the globe, strengthen our biosecurity defenses, and restore ordinary Americans’ trust in public health—a crucial objective if we are to have an effective public health system.