BIORISKSGain-of-Function Studies Need Stricter Guidance: Researchers

Published 18 May 2022

Researchers and biosecurity specialists are calling on the U.S. government to issue clearer guidance about experiments the government might fund which would make pathogens more transmissible or deadly.

An article in Nature discusses calls by researchers and biosecurity specialists on the U.S. government to issue clearer guidance about experiments the government might fund which would make pathogens more transmissible or deadly. The scientists made these pleas on 27 April, during the first of a series of public listening sessions organized by the U.S. National Institutes of Health (NIH). The sessions are part of a months-long review, conducted by the National Science Advisory Board for Biosecurity (NSABB), of U.S. policies governing risky pathogen research.

Max Kozlov, the author of the Nature article, notes that

Manipulating viruses by, say, making them more transmissible in humans can help scientists to answer important questions about how a pathogen evolved or how to defeat it. But US policymakers have struggled to determine when the risk of creating a pathogen that is more dangerous outweighs the benefits of the research. The worry is that such a pathogen could be accidentally released or even weaponized.

The lack of clear guidance from the U.S. government was discussed in detail by Gregory Koblentz, the director of the Biodefense Graduate Program at George Mason University. Kozlov noted Koblentz’s argument:

Many at the listening session pushed for stricter oversight of risky-pathogen research, however. Some suggested that the HHS advisory-panel approach be extended to other US entities. Gregory Koblentz, a biosecurity-policy specialist at George Mason University in Arlington, Virginia, pointed out that pharmaceutical firms, philanthropic institutions and federal agencies, including the Department of Energy, the Department of Agriculture and the Department of Defense, also conduct research on potentially risky pathogens. They should adhere to the same guidelines, he said.

Pandora Report notes that while the debate about gain-of-function (GoF) testing has been strong over the last decade, it has gained renewed attention amid the COVID-19 pandemic and debates about the origin of SARS-CoV-2. In 2014, the U.S. government announced a funding moratorium on GoF experiments that was lifted in 2017 after HHS implemented an extra review layer for such experiments. While most virologists think SARS-CoV-2 spilled-over to humans directly from animals, this has remained a political debate in the U.S. centering on the Wuhan Institute of Virology.

“Regardless of COVID-19’s origin, concerns over these kinds of experiments and challenges in biosecurity standards should still be reviewed and addressed now before it is too late,” Pandora Report says.

. Watch the NSABB listening session recording here and read the Under the NIH Poliscope blog post about it here.