HHS Creates New Oversight Agency for Biosecurity

Amidst heightened concerns about biological terror attacks, keeping important biological research out of nefarious hands has become a high priority for the federal government. In March, the Department of Health and Human Services (HHS) continued its battle against bioterrorism with the creation of the National Science Advisory Board for Biosecurity (NSABB).

The new panel will provide guidance and oversight to federal agencies involved in life sciences research that could be dubbed "dual use." HHS defines dual-use research as valid biological research that could be used to threaten or attack public health or national security.

"The very same tools developed to better the health and condition of humankind can also be used for its destruction," HHS Secretary Tommy G. Thompson said. "For the health and security of our nation, we must take the needed steps to improve biosecurity measures for this type of research."

Projects considered potentially harmful include genetic manipulation of organisms, attempts to increase the lethality of a toxin or methods to weap-onize biological agents or toxins. As an example, according to officials working with the NSABB, a recent project that synthesized a viral genome in two weeks would be considered dual-use. The previous genome synthesis time was approximately two years.

NSABB will have up to 25 voting members serving overlapping two-year and four-year terms. The HHS secretary, as well as several federal department heads, will recommend experts in specific fields such as infectious diseases, bioethics, national security and biodefense to serve on the board. In addition the board will have 15 non-voting members from federal offices such as the president's office, the Department of Defense and the Department of Energy.

The current charter will last for two years, and HHS will grant bi-annual renewals. The board will meet on a quarterly basis, or it could be convened on an as-needed basis. The board's budget has not been published.

Institutional Biosafety Committees (IBC), groups selected at an institute or university to review potentially hazardous lines of research, currently set some parameters for research projects. After the NSABB is fully staffed, it will establish procedures for reviewing those projects that the IBC initially rejects.

HHS is selecting board members to begin serving this summer. Already some in the academic medical community welcome the oversight it will provide. Steven Hinrichs, M.D., professor and director of the University of Nebraska's Center for Biosecurity, said the NSABB will give researchers involved with biological work the supervision they have been seeking.

"We've been looking for this kind of guidance," he said. "As a community, researchers have been concerned about this issue. We've talked about it in the hallway, and we've used caution to the extreme."

Potential dual-use endeavors comprise a considerable percentage of current research, Dr. Hinrichs said, since many of them touch on antibiotic resistance, virulence and infectivity. Until now, the IBC gave Nebraska its safety directions, but the new board will create an unprecedented level of collaboration among federal agencies for biosecurity, he said.

"It's appropriate for all federal agencies to open the door for more discussion and collaboration," Dr. Hinrichs said. "This can only be positive in the way it is structured."

Other researchers agree. Gigi Kwik, Ph.D., assistant professor of medicine at the University of Pittsburgh and fellow at the Center for Biosecurity, said the NSABB will raise awareness of biosecurity risks among the scientific community. The potential problems surrounding this type of research concerned only a small group of scientists, she said.

"The NSABB should build awareness and give actual study case examples of dual-use research," she said. "They should say, 'Look at this technology, and think about the other side.'"

Dr. Kwik hopes the new board will help scientists identify research proposals that could be tenuous in the planning stages, rather than relying on hindsight to highlight mistakes. The board, she said, needs to illuminate a "clear path for when scientists might get into dangerous waters."

But pitfalls are possible once the NSABB begins its work, Dr. Kwik said. Each university will react to the biosecurity guidance in a different way, and the board needs to monitor these responses.

"Even if they say they're offering guidance and not regulations, some universities may end up stifling important research because they want to err on the side of caution," she said. "It's important for them to see how their guidance is interpreted and what effects it has."

In addition, researchers need an established protocol for quick access to NSABB board members if something unexpected and potentially dangerous surfaces during an experiment. Although the link between the board and university administration provides for good communication, Dr. Kwik said a rapid response from NSABB on the best way to channel the unforeseen development would greatly benefit scientists.

The National Institutes of Health (NIH) will manage NSABB while it works with the HHS secretary, the NIH director and all applicable federal agency heads to develop a strategy that will keep scientific investigations safe. No specific measures have been outlined yet, but NSABB is planning to appoint members within two or three months and will create procedures for public dissemination of sensitive research.

-Whitney L.J. Howell

Contact Us    © 1995-2008 AAMC    Terms and Conditions    Privacy Statement