Policy On High-Risk Biological Research Tightened

The Obama administration has announced a new policy to handle the risks posed by legitimate biological research that could, in the wrong hands, threaten the public.

The move comes in response to a huge debate over recent experiments on bird flu virus that got funding from the National Institutes of Health. Critics say the work created mutant viruses that could potentially be dangerous for people, or give terrorists a road map for making a bioweapon.

A committee that advises the government, the National Science Advisory Board for Biosecurity (NSABB), is again meeting Friday to discuss those flu studies. Late last year, it recommended keeping some details secret. But a panel of experts, including flu virologists assembled by the World Health Organization, called for full publication.

The new policy is aimed at preventing this kind of controversy from happening in the future. It covers federally funded research ? both ongoing work and future proposals. And it calls for special reviews of work that involves a list of 15 particularly nasty pathogens and toxins, including highly pathogenic bird flu virus, anthrax and Ebola.

Funding agencies will have to evaluate certain kinds of experiments to see if they pose special risks. The idea is "to really upfront ask the questions: Should they be done? And if so, under what conditions should they be done," explains Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the NIH.

If an agency wants to fund an experiment that might yield potentially dangerous information, Fauci says, scientists could be asked to hold back on publishing details in order to receive funding.

Or, in some cases, the work might need to be classified. Fauci notes that the NIH does not do classified studies. "We would have to refer it to an agency that does classified research, because we don't," he says.

He says the NIH has already taken a look at the ongoing projects it has funded and believes very few will need more scrutiny under the new policy.

"We're not talking about a very large number of studies that are going to get looked at again and might be altered," Fauci says. "We are talking about really, really a little bit more than a handful of studies among hundreds of grants."

And so far, he says, it doesn't look like even these raise significant concerns.

The new policy was welcomed by Richard Ebright, a chemistry professor at Rutgers University who has long called for better control of biological research that could be misused.

"My first reaction was that this is an important step forward ? an overdue step, but an important one," Ebright says.

He notes that a high-profile panel of experts recommended that the government set up a comprehensive oversight system back in 2004. "It was widely expected that a policy would be developed and announced perhaps in 2004, perhaps in 2005," Ebright says. "We're seeing it now perhaps six years late."

The policy will apply to government agencies ranging from the NIH to the Department of Agriculture to the Department of Homeland Security, he notes. He thinks this policy could prevent another controversy like the one currently swirling around bird flu experiments ? but only if agencies take real action.

"If the funding agencies propose only public relations or window dressing as risk mitigation," Ebright says, "then we'll have only public relations and window dressing, and more of these problems arising."

Meanwhile, it's still unclear what will happen with the bird flu studies and the fight over how much information to make public.

The NSABB will wrap up its second meeting on this issue Friday and is expected to again offer advice on whether to publish the full details. But its recommendations are not binding on the government, the scientists or science journals.

Ron Fouchier of Erasmus Medical Center in the Netherlands, one of the scientists who did the work, spoke earlier this week on a live webcast of a science show called This Week in Virology.

"Regardless of what the U.S. government and Dutch government say, the authors and the journals are going to have the last vote on the publication issue," Fouchier said.

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