In the United States, “there are no biosafety rules or regulations that have the force of law,” he said. “And this is in contrast to any other aspect of biomedical research.” There are applicable rules, for example, for experiments on humans, vertebrate animals, radioactive materials, and lasers, but none for research on disease-causing organisms.
Dr. Relman, who also supports the need for independent regulation, cautioned that legal restrictions, as opposed to more flexible guidelines or regulations, could also pose problems. “The law is cumbersome and slow,” he said. At one point in the evolution of laws related to biological warfare, for example, Congress outlawed the possession of smallpox. But the language of the rule, Dr. Relman said, also seemed to prohibit possession of the vaccine because of its genetic similarity to the virus itself. “Trying to fix it took forever,” he said.
Current HHS policy also does not offer much guidance on how to work with scientists in other countries. Some have different policies on Gain of Function research, while others have none.
Johns Hopkins’s Dr. Gronvall argued that the United States government cannot dictate what scientists do in other parts of the world. “You have to adopt self-government,” he said. “You can’t sit on everyone’s shoulder.”
Even if other countries fall short on gain-of-function research policies, Dr. Lipsitch said that shouldn’t stop the United States from developing better ones. As a world leader in biomedical research, the country could set an example. “America is central enough,” Dr. Lipsitch said. “What we do really matters.”
Ironically, the pandemic suspended deliberations on these issues. But there is no doubt that the coronavirus will influence the shape of the debate. Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center, said that before the pandemic, the idea of a new virus sweeping the world and causing millions of deaths felt hypothetically plausible. Now you have seen what such a virus can do.
“You have to think very carefully about any kind of research that might lead to that kind of mishap in the future,” said Dr. Bloom said.