Questions grow over rules governing risky pathogen research

October 28, 2022 – Federal regulation of research on dangerous pathogens such as COVID-19 has loopholes and lacks clarity, according to experts.

Concern about the regulations, and about the wisdom of carrying out potentially risky research—so-called “gain-of-function” experiments—surged after reports about a Boston University study in which researchers tinkered with the Omicron variant of the coronavirus to understand why it causes mild disease.

Some experts quoted in an October 21 Nature article said that the BU research was relatively low-risk. But they also pointed out that such work needs to be carefully reviewed, and that current federal rules aren’t clear about which experiments have benefits that outweigh risks, and who is in charge of monitoring them.

Under current federal rules, every study the National Institutes of Health (NIH) considers for funding is vetted for safety. But critics of the rules say that there needs to be more transparency about how decisions are made on risky research. In addition, some experiments that aren’t federally funded fall outside the scope of these rules. BU officials said their study was in that category.

In September, an NIH advisory board released draft recommendations on reforming federal regulations on risky pathogen research. Marc Lipsitch, professor of epidemiology and director of the Center for Communicable Disease Dynamics at Harvard T.H. Chan School of Public Health, and senior scientist at the CDC’s Center for Forecasting and Outbreak Analytics, told Nature that the draft recommendations don’t go far enough. And, in an October 22 New York Times article, he said, “The first draft makes some important advances and leaves a lot of things unaddressed.” Lipsitch has pushed for tighter rules regarding risky research.

Read the Nature article: Which COVID studies pose a biohazard? Lack of clarity hampers research

Read the New York Times article: Lab Manipulations of Covid Virus Fall Under Murky Government Rules

Learn more

Clearer guidance needed for risky pathogen experiments (Harvard Chan School news)