When will it end? That's what many influenza researchers want to know about the landmark self-imposed moratorium on certain experiments on the H5N1 avian influenza virus that they agreed to earlier this year. The short answer: Who knows?
Initially, the 39 researchers who announced the moratorium on 20 January said it would last just 60 days (Science, 27 January, p. 387). But in February, the loosely organized coalition agreed to an indefinite extension to give experts and the public more time to discuss and address concerns about the safety and wisdom of experiments that could alter H5N1 in ways that make the virus more dangerous to humans. (Other H5N1 research, such as the testing of newly detected strains, continued.)
Now, some of the moratorium's signers are eager for research to resume. But many say they are perplexed about how that decision will be reached and who will decide. “I wish I knew how it was going to be resolved,” says virologist Robert Webster of St. Jude Children's Research Hospital in Memphis, Tennessee, a moratorium signer who was deeply involved in the flu papers controversy. “We haven't discussed this,” says virologist Yi Guan of the University of Hong Kong.
Some key players, meanwhile, predict it will be months before the stand-still ends. “We've still got a lot of homework to do … and some boxes to check” before the moratorium should be lifted, believes Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases (NIAID), which funded the controversial studies by Ron Fouchier of Erasmus MC in Rotterdam, the Netherlands, and Yoshihiro Kawaoka of the University of Wisconsin, Madison, and the University of Tokyo. Although Fauci isn't a signer of the moratorium, he played an influential role in encouraging Fouchier, Kawaoka, and other leading influenza researchers to organize it.
The researchers reluctantly agreed, driven in part by warnings that governments, reacting to public fears and media reports of “doomsday” viruses, might clamp down on the field if scientists didn't act on their own. Some dubbed the move “Asilomar 2,” a reference to the historic 1975 agreement among recombinant DNA researchers that halted experiments in their emerging field until safety guidelines were established.
Before the current moratorium can end, several things have to happen, according to moratorium signers, Fauci, and others:
The U.S. government must release for public comment a document that explains how universities and private laboratories can help federal funding agencies screen proposed research projects for “dual use research of concern” (DURC) that could be used for good or nefarious purposes. The goal of the new DURC screening program, which was announced in late March and covers 15 “high risk” pathogens including H5N1, is to spot problematic studies before they begin. The document—which is expected to run to nearly 30 pages and will be accompanied by a 100-page backgrounder—could be released “sometime this summer,” Fauci says.
Scientists and funders will need to agree on which lines of H5N1 research are—and are not—worth the risks. Particularly problematic, say Fauci and others, are “gain of function” studies, such as Kawaoka's and Fouchier's, in which researchers create mutant viruses that gain capabilities—such as mammalian transmission—that naturally occurring versions do not have. A key step in this process could come in late July, when the heads of NIAID-funded influenza laboratories are scheduled to meet in New York City.
Laboratory safety officials and scientists will need to “at least have a consensus on the level of biocontainment required” for H5N1 studies, says microbiologist Adolfo García-Sastre of Mount Sinai School of Medicine in New York City, a leader of the moratorium. Currently, most H5N1 studies occur in biosafety level 3 (BSL-3) laboratories, but some critics argue that they should be restricted to a small number of higher-containment BSL-4 laboratories.
In the meantime, many signers say the moratorium has already achieved its goal. “The voluntary action … helped calm people's concerns so that discussion could take place,” Kawaoka says. And it “provided the time to deal with these issues in some depth,” says Thomas Mettenleiter of the Friedrich Loeffler Institute in Griefswald–Insel Riems, Germany, even though “no universal ‘solution’ was found.”
↵* With reporting by Martin Enserink.