National Academy of Sciences Releases Key Report on Biomedical Research Liabilities

Article excerpt

The National Academy of Sciences' National Research Council released a report October 8 that calls on the U.S. government to institute a formalized screening system to help mitigate the possibility that biomedical research could be used by terrorists to create biological weapons. The council recommends that the Department of Health and Human Services create an independent National Science Advisory Board for Biodefense to lead the effort. The Bush administration supports the move toward more stringent review. At an October 22 conference in Washington, D.C., President Bush's science advisor, John Marburger III, stated that "no single action by the scientific community could have provided greater reassurance to the public." The following is an overview of the report's recommendations and conclusions:

Educate the Scientific Community

At present, awareness of the potential for misuse of biological knowledge varies widely in the research community. Researchers currently working with select agents are already taking steps to contain these agents physically and protect against planned or unplanned harm. But most life scientists have had little direct experience with the issues of biological weapons and bioterrorism since the advent of the Biological Weapons Convention in the early 1970s, so these researchers lack the experience and historical precedent of considering the potential for misuse of their discoveries. We recommend that the professional societies in the life sciences undertake a regular series of meetings and symposia, in the United States and overseas, to provide both knowledge and opportunities for discussion.

Substantive knowledge of the potential risks is not sufficient, however. The committee believes that biological scientists have an affirmative moral duty to avoid contributing to the advancement of biowarfare or bioterrorism. Individuals are never morally obligated to do the impossible, and so scientists cannot be expected to ensure that the knowledge they generate will never assist in advancing biowarfare or bioterrorism. However, scientists can and should take reasonable steps to minimize this possibility.

Review Experiment Plans

We recommend that [HHS] augment the already established system for review of experiments involving recombinant DNA conducted by the National Institutes of Health [NIH] to create a review system for seven classes of experiments involving microbial agents that raise concerns about their potential for misuse.

Experiments of concern would be those that:

1. Would demonstrate how to render a vaccine ineffective.

2. Would confer resistance to therapeutically useful antibiotics or antiviral agents.

3. Would enhance the virulence of a pathogen or render a nonpathogen virulent.

4. Would increase transmissibility of a pathogen.

5. Would alter the host range of a pathogen.

6. Would enable the evasion of diagnostic/detection modalities.

7. Would enable the weaponization of a biological agent or toxin.

The seven areas of concern address only potential microbial threats. Over time, however, the committee believes it will be necessary to expand the experiments of concern to cover a significantly wider range of potential threats.

[NIH] guidelines require creation of an Institutional Biosafety Committee (IBC) when research is conducted at or sponsored by an entity receiving any NIH support for recombinant DNA research. All of the experiments that fall within the seven areas of concern should currently require review by an IBC.

Review at the Publication Stage

We recommend relying on self-governance by scientists and scientific journals to review publications for their potential national security risks. The committee believes that continued discussion among those involved in publishing journals-and between editors and the national security community-will be essential to creating a system that is considered responsive to the risks but also credible with the research community. …