Lawmakers Must Pass The Risky Research Review Act To Prevent The Next Pandemic

by Bryce Nickels and Jay Bhattacharya

commentary published in Real Clear Politics on September 24, 2024

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Who should decide whether scientists are allowed to modify viruses to make them more infectious and deadly to humans? The surprising answer, until now, is that scientists and institutions like the National Institutes of Health, which have a vested interest in funding and conducting such “gain of function” research, have been the ones deciding whether to undertake such experiments. A bill called the Risky Research Review Act is currently under consideration in the U.S. Senate, which could finally require independent oversight in determining whether such risks are worth taking.

In 2014, the Obama administration froze federal funding for such research while studying how best to regulate it. In 2017, the Department of Health and Human Services implemented a toothless policy to fund research with oversight from a government body called the Potential Pandemic Pathogen Care and Oversight (P3CO) committee. Since then, the P3CO committee has reviewed only three research applications, and NIH funding for engineering more infectious and deadly viruses, including bat SARS coronaviruses, continued apace.

The stakes could not be higher: gain of function research on a potential pandemic pathogen likely caused the COVID pandemic, which led to 7 million deaths – 1 million of them in the United States. Unchecked, such research could definitely cause another pandemic.

In May 2024, after more than a year of deliberation, the White House unveiled its long-awaited proposal for oversight of high-risk scientific research. The response was divided. While some biosafety and biosecurity experts supported it as a small step forward, we found the proposed policy to be a step backward. The proposed policy is complex and convoluted. More importantly, the proposed policy permits scientists and institutions to engineer more infectious and deadly viruses to regulate themselves.

However, there is reason for hope. The Senate Homeland Security and Governmental Affairs Committee is on the verge of approving the Risky Research Review Act (with bipartisan support from Committee Chairman Gary Peters, a Michigan Democrat, and Rand Paul, the ranking Republican on the committee). The bill would create an independent advisory panel, the Life Sciences Research Security Board, within the Executive Branch and be charged with reviewing all federally funded research with the potential to increase the transmissibility or virulence of any potential pandemic pathogen.

Unlike the proposed White House policy, the proposal explicitly lists potential pandemic pathogens covered by the bill. It eliminates the subjective discretion that previous policies provided to funding agency officials like Anthony Fauci. With this discretion, Fauci and others circumvented the P3CO and funded entities like the disgraced EcoHealth Alliance (EHA) – now debarred from federal funding – with tens of millions of taxpayer dollars. The EHA used the money to conduct dangerous bat coronavirus research in collaboration with the Wuhan Institute of Virology.

Some critics argue that the legislation would harm biomedical research. These objections come from a tiny fraction of biomedical researchers who engineer more infectious and deadly viruses for a living and whose research would face substantive regulation for the first time. Those gain-of-function researchers and their lobbyists preposterously claim the bill “would jeopardize federal grant-funded research broadly” or that the review process would involve “vast overreach to research with much lower risk.” These claims are false. The bill narrowly focuses on the tiny fraction of biomedical research that risks causing a pandemic. It would have no impact whatsoever on the vast majority of research.

Even if the Senate passes the measure, there will be no federal regulation of privately funded research with the potential to cause pandemics. How big a concern is this loophole? It’s not merely theoretical. Last year, a media report – subsequently denied – recorded a drug company employee on a hidden camera discussing an apparent research program to make viruses more dangerous. Nevertheless, we believe regulation of federally funded research is the vital issue.

For private companies, engineering potential pandemic pathogens to make them transmissible or virulent makes no sense. The research has no civilian applications and no medical or commercial value. Moreover, any accident in such research would expose a private company to unlimited liability. For these reasons, no private company likely has pursued or would pursue it. Still, as the bill progresses, lawmakers should consider adding an amendment to cover privately funded labs or introduce separate legislation if necessary.

The decision on the Risky Research Review Act could be a watershed moment for preventing lab-generated pandemics. The bill also offers a rare opportunity for compromise and bipartisanship. We urge lawmakers from both parties to come together and support this bill, not as a political statement but as a unified effort to mitigate the risk of another lab-caused pandemic.

Contact your senators to urge them to support the Risky Research Review Act. Remind them the people deserve a voice in experiments that carry such enormous risks. After that, the U.S. should pursue an international agreement to ensure other countries regulate such dangerous research similarly. The life of every human being on the planet is at stake.

Bryce Nickels is a professor of genetics at Rutgers University, lab director at the Waksman Institute of Microbiology, fellow of the American Academy of Microbiology, and co-founder of the non-profit Biosafety Now.

Jay Bhattacharya, M.D., Ph.D., is a professor of health policy at Stanford Medical School, a co-founder of Hillsdale College's Academy of Science and Freeedom, and Collateral Global, a UK charity devoted to documenting the impacts of lockdowns.