As White House mulls microbe research, microbiologists chime in with calls for standardized practices

Scientists with the American Society for Microbiology, or ASM, called for standardized practices, greater public transparency and more in a new report on gain-of-function research, studies where microbes are given characteristics that don’t exist in nature and, in some cases, could make them more dangerous.

The report, published Sept. 13, was co-authored by a think tank of scientists from more than a dozen leading research institutions, including Stanford, Johns Hopkins, the University of Pennsylvania, St. Jude Children’s Research Hospital and Harvard. It comes as the White House considers implementing a regulatory framework for gain-of-function research proposed in January by the National Science Advisory Board for Biosecurity or NSABB.

“Our goal here was to present the issues in an unbiased manner, laying out all of the potential risks and benefits that need to be considered when making decisions about these types of experiments,” steering committee chair Michael Imperiale, Ph.D., a microbiologist at the University of Michigan, told Fierce Biotech Research in an email. The report is the product of a workshop conducted by the ASM in May.

Long controversial, gain-of-function research on pathogens has gained new notoriety thanks to the COVID-19 pandemic. Some politicians have asserted that the virus that causes COVID, SARS-CoV-2, is the result of such studies on coronaviruses, which had been conducted prior to the pandemic at the Wuhan Institute of Virology in Wuhan, China, where the virus is believed to have originated from.

Notably, there is little concrete evidence for this claim, popularized in online circles as the lab leak hypothesis. Researchers who have studied the genetics of SARS-CoV-2 believe it came from animals.

Still, the debate has sparked renewed calls from scientists to address transparency, communication and biosecurity around gain-of-function research. At the same time, scientists have also warned not to overstate the risks, as studies on organisms with pandemic potential—which fall under a subtype called “gain-of-function research of concern” and, more specifically, enhanced potential pandemic pathogen research—are essential to heading off emerging disease. They also make up only a fraction of gain-of-function studies. Other applications include cancer treatments, crop preservation and even faster computers, to name a few.

"The controversy about the origins of SARS-CoV-2 have brought the term ‘gain of function’ into the public arena, which emphasizes the need for a science- and fact-based discussion of the topic,” Imperiale said. The researchers at the workshop in May did not, however, discuss the origin of SARS-CoV-2, because “there is no evidence that the virus was the result of a [gain-of-function] experiment,” he wrote.

At a high level, the scientists suggest creating clear definitions of terms like “gain of function” and “enhanced potential pandemic pathogen” as well as establishing international standardized biocontainment practices and frameworks for deciding under what circumstances it’s safe to conduct research on dangerous pathogens. They also called for strengthening reporting systems for lab workers to better track accidents, including whistleblower protections.

The scientists also vouched for more transparent communication with the public about exactly what gain-of-function research entails, including clear language that “recognizes uncertainties,” the report said. Recent high-profile conversations have been dominated by discussions around the risks and dangers of such studies, with much less said about why they’re necessary or the precautions already being taken.

“To help address these concerns, scientists need to acknowledge risks more clearly and candidly and explain and justify why using a perceived risky approach is necessary to answer certain research questions,” the researchers wrote in the report. “A consensus was reached that scientists must do a better job of communicating risks involved in doing science as well as procedures in place to do science safely.”

While no one, including the NSABB, has called for a blanket ban on all studies of potential pandemic-causing pathogens, even supporters of such research recognize that there are some experiments that should not be performed, the report said. Still, it remains to be seen how those decisions should be made and who should make them, which will require further conversations, the scientists wrote. 

“Both support for and concern about a number of recommendations have been raised, and it is hoped that the U.S. government will carefully consider these thoughtful opinions,” the researchers wrote.

Coming up with evidence-based policies, forming decision-making frameworks and engaging with stakeholders in a transparent way will be vital not only to responding to the inevitable next pandemic but to strengthening trust in science and maintaining progress. 

"Slowing scientific progress has a potential cost to society by making it potentially less prepared for the future...[while] a lack of effective oversight could lead to risks to public health," the scientists said. "Therefore, finding the balance of scientific progress and biorisk mitigation is critical for promoting responsible science."