In the United States, “there are no biosafety rules or regulations that have the force of law,” he said. “And it’s unlike every other aspect of biomedical research.” There are enforceable rules, for example, for experiments with human subjects, vertebrate animals, radioactive materials and lasers, but none for research into disease-causing organisms.
Dr. Railman, who also supports the need for independent regulation, cautioned that legal restrictions as opposed to guidelines or more flexible regulations could also pose problems. “The law is cumbersome and slow,” he said. At one point in the development of laws relating to biological warfare, for example, Congress prohibited the possession of smallpox. But the language of the rule, Dr. Restrictions on possession of the vaccine also appear to be due to the virus’s genetic similarity, Rillman said. “It took forever to try to fix it,” he said.
Current HHS policy also does not provide much guidance on how to work with scientists in other countries. Some have different policies regarding work-for-profit research, while others have none at all.
Dr. Gronwall of Johns Hopkins argued that the US government cannot decide what scientists do in other parts of the world. “You have to adopt self-government,” she said. “You’re not able to sit on everyone’s shoulders.”
Even though other countries fall short on for-profit research policies, Dr. Lipsitch said that shouldn’t stop the United States from developing better. The country can set an example as a world leader in biomedical research. “The United States is sufficiently central,” Dr. Lipsitch said. “What we do really matters.”
Ironically, the pandemic halted deliberations on such issues. But there is no doubt that the coronavirus will affect the size 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 spreading across the world and killing millions of people seemed fantastically plausible. Now they have seen what such a virus can do.
“You have to think really carefully about any kind of research that could lead to that kind of accident in the future,” Dr Bloom said.
