NIH preparing tool to help labs cope with new DURC policy

May 1, 2012 (CIDRAP News) – Federal officials are working on guidance to help local institutions implement the government's new policy on the oversight of life-sciences dual-use research of concern (DURC), an official from the National Institutes of Health (NIH) said today.

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH, revealed the development at a workshop on H5N1 research issues that was hosted by the National Academies. He said the NIH expects to put the guidance out for public comment over the next few weeks and is eager to learn what parts of the new DURC policy will be hard to implement at the local level. "From the top down, it's difficult to tell," he said.

On Mar 29, federal official unveiled a new policy for the oversight of DURC, such as two recent H5N1 transmission studies that raised worries about bioterrorism and scientific censorship. The policy, which came from the NIH Office of Biotechnology Activities, requires federal agencies to routinely review possible risks of federally funded studies involving 15 "high consequence" pathogens and toxins, such as H5N1, Bacillus anthracis, and Ebola virus.

Before Fauci made the announcement, Ann Arvin, MD, professor of pediatric infectious diseases and dean of research at Stanford University, told workshop participants that the new federal policy assigns a difficult set of tasks to institutional biosafety committees (IBCs) at universities and other research organizations.

She said universities have built up their IBC expert groups over time, but a fair number probably lack the specialized expertise needed to assess the kinds and breadth of experiments addressed by the government's new policy. "We at Stanford will not have experts for every pathogen," Arvin said, adding that another problem is that the experts on the topics are likely to be the same ones conducting the research of concern, raising a potential conflict of interest.

Today's National Academies workshop addressed a host of life-sciences DURC issues, including the revolution in life-sciences technologies, experiences with 1918 pandemic flu virus studies, and the research community's social contract with the public. The workshop ended with presentations on governance, oversight, and future steps.

David Franz, DVM, PhD, vice president and chief biological scientist at the Midwest Research Institute in Kansas City, Mo., formerly with the US Army Medical Research Institute of Infectious Diseases (USAMRIID), said he had concerns about the science community taking on another layer of regulation, in light of the events surrounding the H5N1 research debate.

From 2001 to 2009, he said, USAMRIID received 17 new guidance directives and had to hire 40 new employees just to handle assurance issues. Franz is also a member of the National Science Advisory Board for Biosecurity (NSABB), the independent expert group that advises the NIH on DURC issues.

"We should think about changing behavior as well, not just regulating," he said, urging officials to consider the real value and cost of oversight. "We can't forget that it's a competitive world and a dangerous world."

David Heymann, MD, a former World Health Organization  official who now chairs the United Kingdom's Health Protection Agency, told the group that an international consensus including countries that are sometimes reluctant to participate, such as China, Brazil, and India, is needed on life sciences DURC issues.

He said the process could start with "soft norms," advance to "hard norms," and then possibly lead to a more formal convention. Heymann predicted such a process would take decades.

Piers Millet, with the United Nations (UN) Office of Disarmament Affairs' Implementation Support Unit, shared some perspectives from his experience with the Biological Weapons Convention (BWC), a treaty that first went into effect in 1975and currently commits 165 countries to refrain from developing, producing, and stockpiling biological and chemical weapons.

He said the UN disarmament group has a new mechanism in place to look at science and technology issues relevant to BWC issues, and this year members will be examining enabling technologies such as advances in sequencing and synthesis.

See also:

National Academies H5N1 lessons learned background and agenda

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