Federal officials today released a plan to help U.S. agencies decide whether to fund controversial studies that make viruses more dangerous. The guidance may finally bring an end to a moratorium that has kept a handful of experiments funded by the Department of Health and Human Services (HHS) on hold for more than 2 years.
The policy from the White House Office of Science and Technology Policy (OSTP) essentially follows recommendations from last May from an advisory committee that attempted to define the riskiest experiments and spell out when they should be funded. Both critics and supporters of these hotly debated studies welcomed the policy, which some feared would languish if left to the incoming administration of President-elect Donald Trump. But some are reserving judgment until they see the results of the reviews.
Although the new guidance provides no timelines, HHS is working to put the review process in place “as quickly as possible,” said an agency spokesperson on background. The agency says that “any projects that are determined suitable to proceed will do so with appropriate risk mitigation measures in place.”
Concerns about so-called “gain-of-function” (GOF) virus studies—which make viruses more transmissible in humans or able to cause sickness or death—ignited 6 years ago when two virologists revealed that they had tweaked the deadly H5N1 avian influenza to make it spread more easily in mammals. Although meant to help experts prepare for pandemics, some worried that these studies could result in a lab escape of a deadly humanmade virus. Scientists themselves briefly halted, then resumed the H5N1 studies.
Then more papers on GOF experiments, as well as accidents at some U.S. pathogen labs, prompted U.S. officials in October 2014 to impose a top-down moratorium. HHS “paused” funding for 18 GOF projects on influenza, Middle East respiratory syndrome (MERS), and severe acute respiratory syndrome viruses funded by the National Institutes of Health (NIH). (Some were later exempted, but seven flu studies and three MERS projects remain on hold, NIH says.)
The new policy aligns with recommendations made last May by the National Science Advisory Board for Biosecurity (NSABB), with a few tweaks. It covers research that creates “potential pandemic pathogens” or PPPs, rather than adopting NSABB’s term, GOF research of concern. Agencies will decide whether a proposed study involves an “enhanced” PPP by looking at whether the resulting pathogen is “likely” to be highly transmissible and capable of wide and uncontrollable spread in humans, highly virulent, and likely to cause significant sickness and deaths.
Projects involving enhanced pathogens that meet this definition will then be reviewed using eight criteria, such as whether the project is scientifically justified and the benefits outweigh the risks. The report specifically exempts from the reviews certain enhanced PPP studies, such as routine flu surveillance (which involves characterizing viruses found circulating in nature) and the development of high-growth flu strains for vaccines.
Critics have long complained that HHS officials should not be involved in reviewing GOF research that the agency funds because it presents a conflict of interest. The new policy says that agencies “are encouraged to vest oversight for their enhanced PPP review mechanisms in offices that do not report to the head of the agency component” that would fund the research. The HHS spokesperson said that experts from both HHS and other U.S. departments will conduct the reviews.
Harvard University epidemiologist Marc Lipsitch, a longtime critic of GOF studies, says: “I will be watching to see … whether the reviews are robust and free of conflicts of interest real or perceived.”
Virologist Ronald Fouchier of Erasmus University Medical Center in Rotterdam, the Netherlands, who has H5N1 GOF studies on hold, says he is glad to see the OSTP policy. He is “positive that our projects will be reviewed favorably once more … under the new process, and that we can all continue our important work shortly, with negligible risks,” he said.
OSTP also says that NSABB, an advisory group that has no regulatory authority and has struggled at times to address concerns about risky research, is still needed to offer feedback on HHS’s enhanced PPP review process and to provide other policy advice. David Relman, a microbiologist at Stanford University in Palo Alto, California, says he thinks NSABB, which is staffed by NIH, should be moved outside of HHS to avoid conflicts of interest. “The location of its 'home' is very important,” Relman says.