January 15, 2006 (Vol. 26, No. 2)

Voice of Industry Conspicuously Silent in Policy Discussions

The misuse of biological research is increasingly becoming a prominent policy concern. In addition to the biosafety and biosecurity regulations currently in place to oversee biological research, it is now argued that measures are also needed to prevent the techniques developed and knowledge generated from being misused.

Changes are already being made to funding and publication processes to take the dual-use nature of biological research into account. So far, few changes have been made to the working practices of lab researchers, but this is likely to change in the near future.

Adopting Codes of Conduct

One prominent proposal gaining momentum is the adoption of codes of conduct for bioscientists. Such codes would also apply to researchers in the private sector, yet, so far, industry has not engaged in the policy discussions.

The discussions on codes can be traced to a November 2001 White House statement endorsing a solid framework for bioscientists in the form of a code of ethical conduct that would have universal recognition.

This was reiterated shortly thereafter by John Bolton, the then Under Secretary of State for Arms Control and International Security, at the Review Conference of the Biological Weapons Convention, who said, a professional code of conduct for scientists working with pathogenic microorganisms [is critical and timely].

Discussions on the content, promulgation, and adoption of codes of conduct were completed in December 2005 by States Party to the Biological Weapons Convention.

A number of initiatives were taken on codes in between the 2001 statement and the 2005 discussions. The National Academy of Sciences, for example, suggested in its 2003 report Biotechnology Research in an Age of Terrorism: Confronting the Dual-Use Dilemma that the nature of dual-use risks and the responsibilities of scientists should be outlined and added to the codes of ethics of relevant professional societies.

This could then be supplemented by a review of experiments involving biological agents that raise concern about their potential for misuse. The report identified seven experiments of concern, including those that would enhance the virulence of a pathogen and demonstrate how to render a vaccine ineffective. The review of experiments would be added on to the already established NIH system for reviewing recombinant DNA experiments through local institutional biosafety committees.

Other scientific organizations, including the International Centre for Genetic Engineering and Biotechnology, the International Union of Biochemistry and Molecular Biology, and the International Council for the Life Sciences, have also expressed support for codes of conduct.

The American Society for Microbiology (ASM) added concerns about the misuse of biological research to its code of ethics in April 2005. ASM members are now obligated to discourage any use of microbiology contrary to the welfare of humankind, including the use of microbes as biological weapons and will call to the attention of the public or the appropriate authorities misuses of microbiology or of information derived from microbiology.

Individual scientists have also expressed support for codes of conduct, most notably Margaret Somerville and Ronald Atlas who published their own code of ethics for the life sciences in a March 2005 issue of Science.

Most prominent among medical organizations supporting codes of conduct have been the World Medical Association, the American Medical Association, and the British Medical Association. The American Medical Association has drawn up a set of guidelines to prevent the malevolent use of biomedical research, in which physician researchers are asked to assess foreseeable ramifications before they participate in research to balance the promise of benefit from biomedical innovation against potential harms from corrupt application of the findings.

Various intergovernmental organizations have also supported codes of conduct. These include UNESCO; the OECD, which has set up a website to provide an active resource of global information on oversight mechanisms, particularly codes of conduct for the biosciences research community; and the International Committee of the Red Cross, which calls on the scientific and medical communities and industry to adopt professional and industrial codes of conduct aimed at preventing the abuse of biological agents.

Significant & Effective Contribution

The December 2005 meeting of States Party to the Biological Weapons Convention endorsed codes of conduct, agreeing that they can make a significant and effective contribution, in conjunction with other measures, to combating the present and future threats posed by biological weapons and bioterrorism.

It was recognized that all those with a responsibility for, or legitimate interest in, codes of conduct should be involved in their development and adoption. Relevant actors include, among others, academic, governmental and commercial scientists and their professional societies and unions, as well as the pharmaceutical, biotechnology, and other relevant industries.

There are many types of codes, with different functions, implemented and promulgated in different ways. There are aspirational codes, or codes of ethics, that set out ideals that practitioners should uphold. There are educational or advisory codes, often labelled codes of conduct, that go further than aspirational codes by providing guidelines on how to act appropriately.

And there are enforceable codes, or codes of practice, that seek to further codify what is regarded as acceptable behavior. Rather than inspiring or educating in the hope of securing certain outcomes, enforceable codes are embedded within wider systems of professional or legal regulation. While enforceable codes may share with other types of codes aims such as raising awareness, fostering norms, and clarifying individual and collective responsibilities, the focus here shifts to setting out certain permissible processes and ways of carrying out work.

The voice of industry and commercial scientists has been conspicuously absent in the policy discussions on codes for bioscientists to date. This is a significant loss not only to policymakers but also to industry itself, as it is in commercial enterprises that biotechnology is most intensively exploited and where duality is most ambivalent as a result of heavy investments in both intellectual property and highly specialized equipment, and it is precisely here that the key concern about potential misuse of biological research will be.

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