The U.S. government needs to move quickly to clarify and grant urgent exceptions to a recently announced moratorium on funding for potentially risky research involving certain viruses. Those are two of the main points made by a statement approved today by the National Science Advisory Board for Biosecurity (NSABB), which advises the government on life science research that can be used for good or evil.
Today’s statement—which is still being finalized—is in part a response to a host of questions and concerns about the moratorium that researchers voiced at an NSABB meeting last month that focused on the so-called pause, which federal officials announced on 17 October. The pause, which has affected 18 research projects at 14 institutions, halts new federal funding for so-called gain-of-function (GOF) studies that make a pathogen more transmissible in mammals or more pathogenic. It applies to GOF work on any influenza strain and two coronaviruses, MERS and SARS. The idea is to provide a year for experts to work out a U.S. government-wide policy for reviewing GOF studies.
Many researchers have been confused by exactly which viruses, and which experiments, are covered by the policy, said Dennis Dixon, a researcher at the National Institute of Allergy and Infectious Diseases (NIAID) who is leading efforts to implement the policy, during an NSABB teleconference today. But he said his agency—which funds all the research so far affected by the pause—has been working with researchers to clarify matters.
For example, in letters to scientists, officials have made it clear that work involving any kind of influenza virus, and not just highly pathogenic strains, is potentially covered. But the criteria for determining exactly which experiments are GOF and must be put on hold “are much more complex and subtle,” he noted, and applying them “requires a case-by-case assessment” by a panel of NIAID scientists. Scientists are still “sending in the specifics” of their experiments so that the review process “can be done carefully,” Dixon said. The list of 18 affected projects is not expected to grow or shrink appreciably, he noted.
Dixon also addressed questions about what kinds of research might fall under an exemption to the pause that allows the continuation of studies that address an “urgent” public health need. For example, he noted that the government is now examining MERS and SARS research that involves infecting mice with modified versions of those viruses, because wild-type viruses do not help address the targeted research questions. Decisions are expected soon, he said.
That was music to the ears of some NSABB members, who said they were pleased the government appeared to be moving to clear up the confusion. They also reacted positively to an announcement by Andrew Hebbeler, assistant director for biological and chemical threats in the White House Office of Science and Technology Policy (OSTP), that officials have posted a new Frequently Asked Questions document aimed at answering scientists’ questions.
Still, several academic researchers called in to the meeting to share their concerns about how the moratorium is unfolding. Harvard University epidemiologist Marc Lipsitch, who helped push for the moratorium, raised questions about how the government is approaching certain studies that could be defined as GOF, but don’t appear to be covered by the pause. Influenza virologist John Steel of Emory University in Atlanta encouraged federal officials and NSABB members to remember that, even though just 18 projects are covered, the pause is a big deal to affected researchers.
In issuing today's statemnt, NSABB "wanted to make sure that we were formally heard," NSABB Chair Samuel Stanley, the president of Stony Brook University in New York, told ScienceInsider by telephone after the meeting. "There should be clear definitions and pathways to exceptions where they are needed. We wanted to make clear that there is a sense of urgency. These are not the kinds of thing that should be dragging on for months and months."
Stanley says the group also wanted to remind government officials "that there are consequences to these actions, and to make sure that there aren't unintended consequences," such as halting work that is important to protecting public health. The group is also concerned that younger scientists could be scared away from the fields covered by the moratorium.
During the teleconference, Stanley also announced that his group is making headway on developing the recommendations it will make to the government about GOF policy. It has appointed a 13 member working group to develop ideas. The group, which will meet twice by telephone in December and then face-to-face in January, is led by co-chairs Kenneth Berns, a microbiologist at the University of Florida, and biosafety expert Joseph Kanabrocki of the University of Chicago. The group is expected to draw input from a 15 to 16 December meeting on the GOF issue being organized by the National Academies in Washington, D.C. And Stanley said that, despite the early confusion about the pause, his group is “on schedule” to help the government meet its announced goal of devising a new GOF policy and lifting the funding pause within a year. “And we will work very hard to stay on schedule,” he added.
Updated, 5:53pm, 11/25/2014: The story was updated to include comments from Samuel Stanley.