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The US federal government announced a new program yesterday (March 4) designed to prevent bioterrorists from seeing cutting-edge research results they could turn into weapons while still ensuring open communication among researchers.
Using a voluntary, guideline-based approach rather than laws or regulations that impose punishments for noncompliance, the new National Science Advisory Board for Biosecurity (NSABB) will become the nation's monitor of so-called “dual-use” research, whose potential applications can either save lives or destroy them.
“We must take the needed steps to improve biosecurity measures for this type of research,” said Secretary of Health and Human Services Tommy Thompson at a press conference announcing the plan. “But in so doing, we must protect our open process of scientific discovery that has been the linchpin of our research success.”
The board will advise researchers, publishers, funders, and others whether certain research projects should be moved into high-security labs and whether some research results should be voluntarily deleted from published scientific papers. There will be no punishments for not complying. However, in the future, Federal granting agencies could potentially withhold or rescind funding to an institution or grantee who doesn't comply with the board's guidelines.
The NSABB will also serve as a public forum for discussion of all dual-use issues and as a liaison among all federal agencies that conduct or fund life sciences research. Up to 25 members will be chosen in the next 2 months and will include experts from a wide array of fields, including microbiology, law enforcement, veterinary medicine, publishing, public health, pharmaceutical manufacturing, and national defense. Nonvoting members from at least 15 federal agencies will also be included.
Several researchers think that the guidelines will affect only a small minority of research projects and publications. “It could be that 99% of the experiments really aren't all that important” as dual-use risks, said Gerald R. Fink, a professor at the Massachusetts Institute of Technology and a member of the Whitehead Institute. Concerning publishing dual-use results, “We're talking about a small number of papers,” he told The Scientist.
The board is largely modeled on a proposal made in October by a committee of the National Academy of Sciences that Fink chaired. But it is different in significant ways, he said. His committee had proposed that any new board be made part of the National Institutes of Health's (NIH) Recombinant Advisory Committee (RAC), the organization that has assessed the safety of genetics research since the mid-1970s. The new NSABB is a separate entity.
Unlike the RAC, the NSABB will also set policy guidelines. “It's going to do both policy and assessment,” Fink said. Additionally, the NSABB will coordinate policy and assessment across all federal agencies, something his committee had not suggested. By folding in departments like defense and agriculture, he said, the board will make “an amalgam of something that was quite disparate in its supervision.”
Several scientists said that the program announced yesterday included very few details, making it impossible to assess thoroughly. Samuel Kaplan, a professor at the University of Texas at Houston and chair of the American Society of Microbiology's (ASM) publications board, called the announcement “shallow,” especially with regard to publishing.
For instance, given that the board will meet only quarterly, he asked at the press conference how journal editors would get quick guidance about what parts of a problematic paper they should delete. The crowd laughed, he said, but he got no good answer. However, “we're free to go ahead and publish it” without guidance, he told The Scientist. “It's not obligatory that we seek advice from the board.”
Kenneth Berns, professor and director at the Genetics Institute of the University of Florida, said the announcement gave few details about how the federal government would enlist the cooperation of other countries and their researchers. “I think the real challenge is going to be, how do you cast a broad net with this thing beyond the US?” he asked. For instance, half the authors publishing in ASM's journals are foreign, Kaplan told The Scientist.
Berns, chair of the ASM's task force on biological weapons, said he thinks “a large part of the scientific community is in sync with this” and will accept the guidelines. “Anybody who doesn';t follow the guidelines first won't get any federal funding, and probably won't get any private funding from reputable organizations,” he said, “so I think they'll work.”
Fink said he thinks that despite the fact that “the devil is in the details,” the program has started in the right direction, unlike the mandatory select agent regulations under which “you go to jail if you don't enumerate all the strains you have” or make other mistakes. “That plan was wrong at the beginning,” he said, “whereas this plan, I think, has all the earmarks of the right system.”
References
| 1. | | [http://www.nih.gov/news/pr/mar2004/hhs-04.htm]
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| | | A. Adams, “Science under glass: Inside a biosafety level 4 lab,” 18:30 The Scientist, February 2, 2004. Return to citation in text:
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| | | Gerald R. Fink Return to citation in text:
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