Advisory board tackles life sciences issues

Board examines dual use potential

Research into the intricacies of the human genome has opened up a new era for biologic and biomedical research. Investigators are poised to explore the almost unlimited potential to diagnose, treat and possibly cure and prevent many diseases once thought untreatable.

But such advances also have a dark side — the more scientists learn about how our bodies function at the molecular level, the higher the potential that such knowledge can fall into the wrong hands.

A new advisory board for the Department of Health and Human Services (HHS) has been charged with the task of developing criteria to determine when life sciences research has the potential to be used in unintended and harmful ways, and how such research can be properly secured.

On June 29, HHS Secretary Mike Leavitt announced the appointment of 24 members to the new National Science Advisory Board for Biosecurity (NSABB). Following the appointments, the board held its first meeting June 30-July 1 in Bethesda, MD.

The possibility for misuse?

International cooperation and the rapid sharing of information across national borders yielded impressive results during the SARS crisis and in the effort to combat the spread of avian influenza, NIH director Elias Zerhouni, MD, noted in remarks to open the first meeting. But this new age of discovery and cooperation poses significant risks.

"There is no doubt that research intended for the benefit of humankind can also be used for malevolent purposes," he said. "Because of advances in recombinant DNA research, molecular genetics, and other life sciences disciplines, we have come to the root, the real root of life systems and biological systems. We have increasing abilities to routinely alter biological systems to explore the mechanisms of human, animal, and plant disease. Yet it is an unfortunate fact of life that there are individuals who would use these technologies and discoveries to terrorize nations and threaten public health."

The NSABB is needed to develop criteria to determine what types of research have the potential for such "dual use" and to recommend ways to prevent discoveries from being used in ways that would be harmful.

The federal government has passed laws regulating the use of specific biologic and chemical agents, but a "dynamic, evidence-based, aggressive approach" by the advisory board is needed to ensure that the international scientific community can continue to cooperate across borders, while preventing discoveries from being misused.

Overly strict security measures could do more harm than good, if they stifle good cooperation in an effort to prevent bad, he added.

"At the end the day," Zerhouni concluded, "it is my personal belief that the goal will be achieved when a scientist himself or herself asks themselves a question, could this be misused? What could I do to protect that from happening? That culture of responsibility is probably the task all of us as leaders of agencies and of this committee are going to have to develop and find way to get to."

A code of conduct

The board’s overall charge is to develop criteria that can be use to identify dual use research and to develop guidelines that can provide for oversight of such research and research results, says NSABB executive director Thomas Holohan, MD, a physician serving in the NIH Office of Biotechnology Activities, which will manage and administer the board’s work.

Specifically, the board will advise the HHS and NIH on developing national policies to govern local review and approval of dual use research studies, including guidelines for case-by-case review by institutional biosafety committees. The board also may develop criteria and processes calling for referral of specific classes of research or specific studies for review at the national level by the NSABB itself.

"The board is also asked to provide recommendations on the development of a code of conduct for scientists and laboratory workers," Holohan notes. "It will also advise on the development of mandatory education and training in biosecurity for scientists and laboratory workers at federally funded institutions, as well as recommend national policies for publication and communication and dissemination of methods and the results of dual use research."

The board will meet quarterly, with special meetings called on an as-needed basis by the secretary of Health and Human Services, and all meetings will be open to the public unless HHS deems it necessary to close a meeting, Holohan said.

An archived webcast of the meeting’s proceedings is available on the NSABB web site at www.biosecurityboard.gov, and more information on the agency’s mission and work is posted there as well.