The White House announced stricter rules for researching potentially dangerous microorganisms and toxins to prevent laboratory accidents that could spark a pandemic.
The new policy, announced Monday night, comes after years of deliberation by a panel of experts and intense public debate over whether the coronavirus originated in China's animal markets or in a laboratory. It was done.
Many researchers are concerned that governments have been too lax about laboratory safety in the past, and some are using dangerous methods that can spread viruses, bacteria, and fungi rapidly among people. Some have even called for the creation of an independent body to make decisions about experiments. It becomes more deadly. But others warned against imposing restrictive rules that would stifle valuable research without ensuring people's safety.
The debate has become even more heated during the pandemic, as politicians question the origins of the coronavirus. Those who suggested it came from a lab raised concerns about research that tweaks pathogens to make them more dangerous, known as “gain-of-function” research.
The new policy applies to federally funded research and increases government oversight by replacing short lists of dangerous pathogens with broader categories into which more pathogens can be classified. The policy pays attention not only to human pathogens, but also to pathogens that can threaten crops and livestock. And it also provides details about the types of experiments that will likely attract the attention of government regulators.
The rule is expected to go into effect within a year, giving agencies and departments time to update their guidance to meet the new requirements.
“This is a huge and important step forward,” said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Safety and a longtime advocate of stricter safety regulations. “I think this policy is what a reasonable citizen would expect in terms of monitoring one of the most infectious and deadly organisms in the world.”
Still, the policy does not embrace the most aggressive proposals made by lab safety advocates, such as creating an independent regulatory agency. Certain types of research are also exempt, such as disease surveillance and vaccine development. Also, some of the policies are recommendations rather than mandatory government requirements.
“This is a gradual policy shift, and there are some more important signals about how the White House expects this issue to be handled going forward,” said Nicholas Evans, an ethicist at the University of Massachusetts Lowell. There is,” he said.
Experts have been waiting for this policy for more than a year. Still, some said they were surprised the bill was announced at such a politically fraught time. “I had no expectations, especially in an election year,” Dr. Evans said. “It's a pleasant surprise.”
Under the new policy, scientists who want to conduct experiments will have to submit proposals to universities and research institutes, which will determine whether the research poses a risk. Potentially dangerous proposals are reviewed by government agencies. The most scrutinized experiments are those that could have the most dangerous consequences, such as tweaking a pathogen that could cause a pandemic.
In its guidance document, the White House provided examples of research that could be expected to be subject to such scrutiny. In one case, they imagined scientists trying to understand the evolutionary steps necessary for a pathogen to more easily transmit between humans. Researchers may try to create infectious strains for research by repeatedly infecting human cells, for example in Petri dishes, and allowing the pathogen to evolve ways to enter cells more efficiently.
Scientists who do not comply with the new policy may lose federal funding for their research. Support for university-wide life science research may also be cut off.
One of the weaknesses of the existing policy is that it applies only to funds given by the federal government. But the National Institutes of Health and other government agencies have suffered from funding stagnation for years, leading some researchers to turn to private sources instead. In recent years, for example, the Crypto Titans have poured money into pandemic prevention research.
The new policy does not place direct government regulation on privately funded research. But institutions that receive federal funding for life sciences research should apply similar oversight to scientists who conduct research with support from outside the government.
“NIH does a lot of work everywhere in the world, so this would effectively limit them,” Dr. Evans said.
The new policy takes into account advances in biotechnology that may lead to new risks. For example, if a pathogen goes extinct, it can be brought back by recreating its genome. Research on extinct pathogens will be subject to the highest level of scrutiny.
Dr. Evans also pointed out that the new rules highlight the risks that laboratory research poses to plants and animals. In the 20th century, the United States and Russia conducted extensive research into crop-destroying pathogens, including a fungus that killed wheat, as part of their biological weapons programs. “This is an important signal from the White House,” Dr. Evans said.
Gigi Gronvall, a biosafety expert at the Johns Hopkins Bloomberg School of Public Health who has advocated for avoiding unnecessarily restrictive rules, argues that the value of necessary research during a crisis like the current bird flu outbreak is critical. He praised the policy's recognition of this.
“I approached this policy with cautious optimism,” she said of the policy. “The direction seems to be to do it carefully so as not to have a chilling effect on needed research.”
Still, Dr. Gronvall said much will depend on how federal health officials interpret the policy. He said he would be interested to know, for example, how much additional review is planned and how the additional workload will affect the pace of proposals.