More than 3 years after imposing a moratorium on U.S. funding for certain studies with dangerous viruses, the National Institutes of Health (NIH) in Bethesda, Maryland, today lifted this so-called "pause" and announced a new plan for reviewing such research. But federal officials haven’t yet decided the fate of a handful of studies on influenza and Middle East respiratory syndrome (MERS) that were put on hold in October 2014.
Two investigators whose controversial studies on deadly avian influenza viruses are among 11 on hold welcomed the end of the pause. “This NIH decision allows us to move forward,” virologist Yoshihiro Kawaoka of the University of Wisconsin in Madison wrote in an email.
NIH officials believe the pending studies are probably outdated and scientists will want to submit new proposals. The new process, NIH Director Francis Collins says, “will help to facilitate the safe, secure, and responsible conduct of this type of research.” Critics of the studies, meanwhile, are withholding judgment until they see how the review process plays out.
Concerns over so-called “gain-of-function” (GOF) studies that make pathogens more potent or likely to spread in people erupted in 2011, when Kawaoka’s team and Ron Fouchier’s lab at Erasmus Medical Center in Rotterdam, the Netherlands, announced that they had modified the H5N1 bird flu virus to enable it to spread between ferrets. Such studies could help experts prepare for pandemics, but pose risks if the souped-up pathogen escapes the lab. After a long discussion, the National Science Advisory Board for Biosecurity (NSABB) decided the two studies should be published and federal officials issued new oversight rules for certain H5N1 studies.
But U.S. officials grew uneasy after the publication of new GOF papers and several accidents in U.S. biocontainment labs. In October 2014, they announced an unprecedented “pause” on funding for 21 GOF studies of influenza, MERS, and severe acute respiratory syndrome viruses. (At the time, NIH said there were 18 paused studies.) NIH eventually exempted some studies found to pose relatively little risk. But eight influenza studies and three MERS projects remained on hold.
NSABB then developed a set of criteria for determining when such studies should be allowed, such as whether there are less risky ways to address the same question. Last January, White House science officials told NIH’s parent, the Department of Health and Human Services (HHS), to craft policies using the criteria for what officials now call “enhanced potential pandemic pathogens” (PPPs).
Today, along with NIH lifting the pause, HHS released its review framework. Any proposal that passes scientific peer review and fits the PPP definition will be reviewed by an HHS group with wide-ranging expertise, from biosafety and security to ethics and law. The panel will weigh the benefits and risks and may recommend that the proposed study be rejected, allowed to move forward, or permitted with modifications.
NIH doesn’t expect the investigators whose work was paused to resume where they left off. The studies are “probably obsolete,” Collins said in a call with reporters late yesterday. Instead, NIH anticipates that researchers will submit fresh proposals.
Collins says that because NIH has already allowed some of the original paused studies to proceed, the new policy isn’t “a dramatic change … but now we have a policy that is much more transparent and clear."
Fouchier says resubmitting proposals won't take much time: "The questions are still the same, but we will want to work with current virus strains," he says. "It's basically a matter of 'find and replace.'" Because his work passed an extensive review in 2014, before the pause took effect, "I assume I'll be able to shepherd it through this time."
Harvard University epidemiologist Marc Lipsitch, who co-led a group of researchers that lobbied for the GOF pause, calls the HHS framework “a small step forward.” He adds, “The question is how such reviews will play out in practice.” Lipsitch is concerned that the HHS panel will interpret the NSABB criteria in such a way that experiments like the 2011 H5N1 studies—which in his view should not be funded—will get the green light.
With reporting by Martin Enserink.