By Julie Steenhuysen and Sharon Begley
CHICAGO/NEW YORK (Reuters) - The White House on Wednesday charged U.S. universities with policing their research on dangerous pathogens that could be used both for legitimate purposes and for biowarfare or bioterrorism.
The long-awaited guidelines, issued by the White House Office of Science and Technology Policy, lay out a framework for university safety review boards to identify research that falls into this category, known as "dual use research of concern."
Such research must be reported to the federal government, the policy states. Failure to comply could result in the loss of federal funding for the researcher or even the broader university.
Scientists who have raised concerns about the risks posed by research on the world’s most dangerous pathogens were not impressed.
“There is absolutely nothing new of substance,” said Richard Ebright, a professor of chemistry and chemical biology at Rutgers University. “It’s a cruel joke.”
The policy release follows the worst U.S. biosafety crisis in years, in which researchers at the U.S. Centers for Disease Control and Prevention potentially exposed dozens of workers to anthrax and sent samples contaminated with deadly bird flu to unsuspecting scientists at the U.S. Department of Agriculture.
Ebright, who testified at a congressional hearing this summer on biosafety lapses at CDC, said the policy on dual-use research was proposed in March 2012.
Since last year, it has been implemented by federal agencies and research institutions that receive federal funding, he said, “so this is just a reiteration of current practice.”
The substance of the policy also falls short, Ebright and other biosafety experts said. Ebright was particularly critical of a requirement to perform an assessment of the risks and benefits of proposed research. The policy requires scientists only to list the possible risks and potential benefits, but not to quantify them.
“That is not how you do a true risk-benefit analysis,” Ebright said, and leaves the public and regulators in the dark about the riskiness of an experiment.
The policy is also silent on studies that most concern many biologists, known as gain-of-function research. These include experiments in which bacteria or viruses are altered in ways that make them more contagious or more lethal.
That was a major concern of several former members of the National Science Advisory Board for Biosecurity (NSABB), a 23-member panel that advises the government on how and whether research on dangerous pathogens should be conducted.
In July, the National Institutes of Health abruptly dismissed 11 eminent scientists from that panel
Earlier this year, scientists formed the Cambridge Working Group comprising more than 300 signatories, including three Nobel laureates, to call for a moratorium on the creation of such “potential pandemic pathogens” until a rigorous assessment of the risks can be conducted.
Amy Patterson, associate director for biosecurity and biosafety policy at the National Institutes of Health, said the new policy "is aimed at addressing the issue of intentional misuse."
She said the gain of function question goes beyond security to basic biosafety and containment issues.
"This is an active area of consideration right now within the US government," she said, adding that the issue will be taken up by the NSABB in the next few weeks.
(Reporting by Julie Steenhuysen and Sharon Begley; Editing by Chizu Nomiyama)