Studies of H5N1 bird flu to require strict reviews


U.S. health officials announced plans for scientists to move forward with controversial research on the deadly H5N1 bird flu and said that any discoveries about how the virus might gain the ability to spread easily among humans should be shared with other scientists and the public.

The new policy, released Thursday by the National Institutes of Health, requires that studies aimed at making the virus more dangerous would now be subject to a heightened level of review. Effective immediately, researchers will have to explicitly delineate the potential science and health benefits — as well as safety risks — involved in their work before they can get government funding, said Dr. Amy Patterson, NIH associate director for science policy.

The NIH, through the National Institute of Allergy and Infectious Diseases, is a leading funder of flu research.


The H5N1 virus is endemic in some bird populations in Asia and the Middle East, and began infecting people in the late 1990s. The World Health Organization has confirmed 620 cases of H5N1 in humans since 2003. It has been fatal nearly 60% of the time.

So far, the virus has mostly spread from birds directly to humans. But public health officials fear a pandemic could be in the offing if it were to mutate in a way that makes it easier to spread from person to person.

That’s why scientists have been trying to see whether they can create a more contagious strain of H5N1. The new policy will allow that work to resume while trying to ensure that the virus can’t escape the laboratory and cause a deadly pandemic, through accidental or deliberate means.

“Further understanding this virus is imperative,” Patterson said.

The concern over the H5N1 experiments dates to 2011, when virologists Ron Fouchier of Erasmus Medical Center in the Netherlands and Yoshihiro Kawaoka of the University of Wisconsin announced that they had independently created bird flu strains that could be spread through the air among ferrets, which are often studied in the lab as proxies for humans.

The scientists were interested in seeing how mutations in the virus’ genetic code could make such mammal-to-mammal transmission possible. Learning which DNA changes were key could help public health officials spot potentially dangerous alterations that emerge in the wild. The information also might help scientists develop better vaccines or antiviral drugs, Fouchier and Kawaoka said.

But just as the researchers were preparing to publish reports on their work in the journals Science and Nature, the U.S. National Science Advisory Board for Biosecurity asked that their studies be redacted so that the recipe for the contagious version of the virus would not fall into the wrong hands.


Fouchier, Kawaoka and dozens of other scientists agreed to a voluntary moratorium on their experiments as they worked with government agencies to identify the safest manner to proceed. The new rules are an outgrowth of those deliberations.

The biggest change is the addition of two new levels of review for research proposals involving this type of H5N1 experiment, Patterson said.

First, government agencies that are considering funding H5N1 transmission experiments will have to make sure the proposals satisfy seven criteria, including requirements that the research addresses scientific questions important to human health; that there are no other ways to answer those questions; and that safety and security risks can be managed effectively.

If the proposals pass these tests, they will undergo “a higher level of scrutiny” by reviewers at the Department of Health and Human Services, who will further consider the risks and benefits.

One of the seven criteria is a requirement that research will be “anticipated to be broadly shared in order to realize its potential benefits to global health.”

Michael Osterholm, a infectious disease researcher at the University of Minnesota and a member of the biosecurity panel, objected to that requirement.

“The genie will get out of the bottle,” he said. “If we publish this, it’s right there for everyone to know. Any lab in the world could do the same work.”

H5N1 researchers lifted their self-imposed ban in January, stating that they would resume work once governments announced safety plans.

Scientists who depended on U.S. funding were not able to proceed immediately. But now that the U.S. guidelines are out, researchers who halted their H5N1 transmission studies can submit documents addressing the criteria of concern. Patterson said that the department-level review process could be expected to take about three to four weeks.

Patterson said that Fouchier’s and Kawaoka’s experiments in 2011 would have qualified for funding under the new rules, but that “there would have been a lot more upfront articulation” of the risks and benefits.