Research Institutions Will Have To Identify 'Dual-Use' Pathogens

Any research institution that receives federal funding will soon have to screen certain kinds of scientific experiments to see if the work could potentially be misused to endanger the public.

The new policy will take effect next year, and it's the latest effort by the U. S. government to come to grips with so called "dual-use" biological research—legitimate medical or public health studies that could reveal how to make already-worrisome germs or toxins even more destructive.

Only a small number of experiments are expected to raise this type of concern; one official said a recent review of already-funded research found only a handful of projects. But some of this research, including a lab-altered bird flu virus, has proven hugely contentious, with scientists sharply divided on whether it should even be done.

Research institutions have long had "biosafety" review boards charged with making sure that infectious agents and toxins will stay safely contained within labs. The new policy means that universities and other federally-funded science organizations will have to consider whether certain kinds of experiments might generate knowledge that could provide a recipe for a weapon or attack.

The required review covers work that involves a list of 15 nasty toxins and pathogens, such as Ebola and anthrax, and seven categories of sensitive experiments that scientists sometimes call "the Seven Deadly Sins." These include studies that could make a germ more deadly or contagious, or that would let it evade existing treatments or diagnostic tests.

The new policy for research institutions is similar to another one issued in March of 2012 that requires government funding agencies like the National Institutes of Health (NIH) to screen proposed research projects for potential dual-use dangers before issuing grants.

"It's a complementary process," says Amy Patterson, associate director for biosecurity and biosafety policy at the NIH. "I think it is important for institutions and investigators to also gain expertise in the mind-set." As a project is underway, she adds, "They are going to have to be mindful as well of whether dual-use issues emerge during the conduct of the science."

All of this regulatory action came in the wake of a high-profile controversy over two experiments that made a kind of highly-pathogenic bird flu more contagious in ferrets, the lab stand-in for humans. Critics said that the researchers had created super-flus that could cause a pandemic in people, if they ever fell into the wrong hands or got out of the lab.

The government put a special review process in place for this type of flu research, but scientists are still arguing about the wisdom of conducting research intended to give pathogens new properties, sometimes called "gain-of-function" work.

"The U. S. government's approach to gain-of-function studies is definitely an area that we are actively discussing," says Andrew Hebbeler, assistant director for biological and chemical threats at the White House Office of Science and Technology Policy.

He says officials want advice on gain-of-function studies from a government advisory committee called the National Science Advisory Board for Biosecurity.

That committee reviewed the controversial bird flu experiments back in 2011 and 2012. But the government has not convened this advisory group for almost two years. Federal officials recently appointed a slew of new members and have scheduled a meeting for next month.

"One of the agenda items will include thinking through risks and benefits associated with gain-of-function studies," says Hebbeler. "As these discussions advance within the government, we hope to have more to share with you in the future."

The National Academies of Sciences is also planning to wade into the debate soon, with a symposium that could be held later this year.