In the United States, “there are no biosafety rules or regulations that have the force of law,” he said. “And that is in contrast to all other aspects of biomedical research.” There are enforceable rules, for example, for experiments with humans, vertebrates, radioactive materials and lasers, but none for research with pathogenic organisms.
Dr. Relman, who also advocates the need for independent regulation, warned that legal restrictions as opposed to directives or more flexible regulations could also pose problems. “The law is cumbersome and slow,” he said. For example, at one point in the development of biological warfare laws, Congress banned the possession of smallpox. But the language usually said Dr. Relman also appeared to ban possession of the vaccine because of its genetic similarity to the virus itself. “Trying to fix it took forever,” he said.
The current HHS directive also does not provide many guidelines for working with scientists in other countries. Some have different guidelines for research into gain of function, while others have none at all.
Dr. Johns Hopkins’ Gronvall argued that the US government cannot dictate what scientists do in other parts of the world. “You have to manage yourself,” she said. “You can’t sit on everyone’s shoulder.”
Even if other countries are insufficient in terms of research policies to gain functions, said Dr. Lipsitch that this shouldn’t stop the United States from developing better ones. As the world leader in biomedical research, the country could set a good example. “The United States is sufficiently central,” said Dr. Lipsitch. “What we do is really important.”
Ironically, the pandemic has put deliberations on such issues on hold. But there is no question that the coronavirus will affect the shape of the debate. Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center, said the idea that a new virus was flooding the world and causing millions of deaths was hypothetically plausible before the pandemic. Now he has seen what such a virus can do.
“You really have to think carefully about any kind of research that could lead to such a mishap in the future,” said Dr. Bloom.