National Academy of Sciences Releases Key Report on Biomedical Research

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. The committee believes that the statement produced by a group of editors from major life science journals in February 2003 is an important step in this process. On the broader question of classification, the committee believes that the principle set out by the Reagan [a]dministration in 1985 in National Security Decision Directive 189—that the results of fundamental research should be unrestricted to the maximum extent possible and that classification should be the mechanism for what control might be required—remains valid and should continue to be the basis for U.S. policy.

Create a National Science Advisory Board for Biodefense (NSABB)

The NSABB would serve as a point of continuing dialogue between the scientific community and the national security community and as a forum for addressing issues of interest or concern. It would provide case-specific advice on the oversight of research and the communication and dissemination of life sciences research information that is relevant for national security and biodefense purposes.

Protect Against Misuse

The federal government should rely on the implementation of current legislation and regulation, with periodic review by the NSABB, to provide protection of biological materials and supervision of personnel working with these materials.

Safeguarding the collections of existing agents is an obvious priority that in large measure is being addressed through recently passed legislation and implementing regulations. The designation of certain pathogens as “select agents” is an appropriate starting point for identifying strains and isolates that need to be secured. It is crucial to avoid well-meaning but counterproductive regulations on pathogens.

In some areas of technology, the limiting ingredient is the existence of trained personnel. General microbiological training sufficient for culturing and growing pathogenic microorganisms at levels of significant concern is available in high school and first[-]year college biology courses; majors in microbiology would be sophisticated enough to grow many select organisms. Moreover, training in basic microbiology is widely available outside the United States. The procedures for admitting foreign students and scientists to the United States for study and collaborative research must reflect the importance of keeping universities as open educational environments. Efforts to identify or control knowledgeable personnel within the United States are impractical, and surveillance of such personnel would not, in our opinion, offer much security.

Develop a Role for the Life Sciences

National security and law enforcement communities should develop new channels of sustained communication with the life sciences community about how to mitigate the risks of bioterrorism. By signing and ratifying the Biological and Toxin Weapons Convention, the United States renounced the use and possession of such offensive weapons and methods to disseminate and deliver them. Given the increased investments in biodefense research in the United States, it is imperative that the United States conduct its legitimate defensive activities in an open and transparent manner. It might be desirable for components of the national security community to establish advisory boards of basic scientists and clinicians with expertise in areas such as viral disease, bacterial pathogens, biotechnology, immunology, toxins, and public health, as well as others in the area of basic molecular biology. These advisory boards could help members of the intelligence and law enforcement communities keep current in relevant areas of science and technology and provide a trusted set of advisors to answer technical questions.

Harmonize International Oversight

International policymaking and scientific communities should create an International Forum on Biosecurity to develop and promote harmonized national, regional, and international measures that will provide a counterpart to the system we recommend for the United States. Just as the scientific community in the United States must become deeply and directly engaged, the commitment of the international scientific community to these issues is needed to implement the recommendations contained in this report.

We do not expect our recommendations to provide a “roadmap” that could simply be adopted internationally without significant modifications or adaptations to local or regional conditions. But any effective system should include all the issues addressed by our recommendations. The committee recommends convening an “International Forum on Biological Security” to begin a dialogue within and between the life sciences and the policymaking communities internationally. Among the topics for this forum are:

• Education of the scientific community globally, including curricula, professional symposia, and training programs to raise awareness of potential threats and modalities for reducing risks as well as to highlight ethical issues associated with the conduct of biological science.
• Design of mechanisms for international jurisdiction that would foster cooperation in identifying and apprehending individuals who commit acts of bioterrorism.
• Development of an internationally harmonized regime for control of pathogens within and between laboratories and facilities.
• Development of systems of review to provide oversight of research, including defining an international norm for identifying and managing “experiments of
concern.”
• Development of an international norm for the dissemination of “sensitive” information in the life sciences.

Conclusion

Throughout the committee’s deliberations there was a concern that policies to counter biological threats should not be so broad as to impinge upon the ability of the life sciences community to continue its role of contributing to the betterment of life and improving defenses against biological threats. Caution must be exercised in adopting policy measures to respond to this threat so that the intended ends will be achieved without creating “unintended consequences.” On the other hand, the potential threat from the misuse of current and future biological research is a challenge to which policymakers and the scientific community must respond. The system proposed in this report is intended as a first step in what will be a long and continuously evolving process to maintain an optimal balance of risks and rewards. The committee believes that building upon processes that are already known and trusted and relying on the capacity of life scientists to develop appropriate mechanisms for self-governance offers the greatest potential to find the right balance. This system may provide a model for the development of policies in other countries. Only a system of international guidelines and review will ultimately minimize the potential for the misuse of biotechnology.

The full report is available at: www.nas.edu