Why a Code of Conduct for "dual-use" Research?

Dr. Slavko Bokan, M.D.
Croatian Ministry of Defense
Defense Policy and Planning Department
Ilica 256 b, HR-10000 Zagreb, Croatia

Introduction

           Today it is very important to consider the content, promulgation and adoption of codes of conduct for scientists in the field of NBC research. The threat of scientific and technological developments being used for destructive purposes, such as the development of novel biological weapons, is a real one. We believe codes of conduct can help to reduce the risk that scientific research will be misused. Because no government can oversee all scientists and experiments across a nation, codes of conduct for NBC scientists are crucially necessary. Codes of Conduct may offer the greatest opportunity for improving security of research at the level of individual scientists and also increase the understanding of security, improve moral and ethical responsibilities, create a "culture of responsibility and accountability", and set professional standards that may have legal implications.

           Practical measures should be established to prevent hostile use of the life sciences and "dual-use" research. Much basic knowledge is potentially "dual-use". Sensitive research results and information should be presented very carefully and research results for application must be classified. This paper was earlier presented to the CBMTS group of professionals and does provide very important considerations for the content, promulgation and adoption of codes of conduct for scientists in the field of NBC research and for inducing discussions between scientists with an aim on improving protection of sensitive research results and information in the field of NBC Defense sciences.

           The potential threat from misuse of current and future dual-use research in the field of NBC Defense is a challenge to which the scientific community must respond. The rapid advances in the life sciences and the worldwide growth of biotechnology industry only add urgency of this task.

           Essential for the entire scientific community is to enable interaction between scientists and to improve knowledge. Essential for each scientist or scientific group is to get acknowledgement from the respective scientific community, thus to prove the value of the work, and thus to get further funding. Scientists are not lawyers, doctors, ethicists, or sociologists and their work is very different. Scientists are explorers, and can't know and predict the consequences of an experiment.

           Code of conduct is formal statement of values and professional practices of a group of individuals with a common focus, either an occupation, academic field, or social doctrine. It is a generally accepted set of conventional principles and expectations that are considered binding on any person who is a member of a particular group.

           "Dual-use" is a term often used in politics and diplomacy to refer to technology which can be used for both peaceful and military aims, usually in regard to the proliferation of nuclear weapons.

           Biotechnology is intrinsically "dual-use" and dual-use items are covered under the Export control regimes which include: Zangger Committee (Nuclear Exporters Committee) and Nuclear Suppliers Group - NSG, non-proliferation of nuclear weapons (NPT); Australia Group, non-proliferation of chemical and biological weapons; Missile Technology Control Regime - MTCR, non-proliferation of unmanned delivery systems for WMD; and Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Technologies.

           Australia Group promotes harmonized export controls for technology relevant to CBW, but limited utility in combating terrorism. "Dual use" Research includes life sciences research with legitimate scientific purpose and that may be misused to pose a CBRN threat to public health and national security.

           We recognize Penal Code as systematically arranged and comprehensive collection of laws, Code of Practice (enforceable code) as any systematic collection of regulations and rules of procedure or conduct, Code of Conduct (educational code) as a generally accepted set of principles, and Code of Ethics (inspirational code).

           Codes of Conduct can help reduce misuse of scientific research. Today, it is extremely difficult to list guiding principles for all scientific work. Many valuable guidelines for professional conduct already exist.

           A Code of Conduct for the life sciences could be an effective element if it is designed to promote awareness of the dual use dilemma, and it pro-actively obligates the researcher to engage in reflection.

           Scientists participating in biomedical and bioscience research should agree: not to engage knowingly in research aimed at producing biological agents for use in hostile conflicts, to become informed and be aware of possible dual use aspects of their research and to carry out risk assessments at each stage of the research process as a reflective action.

           The channels for communicating knowledge are numerous and diverse and we have today over 10,000 journals in life sciences. The number of trained biologist is huge and they work in many different kinds of institutions. Thinking enemy can outdo nature-genetic manipulation to create new pathogens, enhance weaponization, and dissemination. Novel pathogens are far easier to create than new countermeasures.

           Biosafety is essential for all infectious disease and recombinant DNA research and for clinical diagnostic laboratories. BSL-3 and BSL-4 laboratories provide critical infrastructure for biosafety. Biosafety as a science and application is devoted to the protection of scientific personnel, the public and the environment from biological hazards. Biosecurity is an extension of biosafety. Biosecurity includes physical security and ensuring that individuals with access to dangerous pathogens are trusted and it must be global in reach. Biosafety and biosecurity are closely interlinked, and common systems are required to manage both effectively. Codes of Conduct must provide for biosafety, biosecurity, and bioethics.

A code of conduct should not interfere in biological science; i.e.,

1. Basic research on infectious diseases
   
   • basic research on the pathogenetic mechanisms of infectious agents,
     
   • host reactions,
     
   • development of new animal models,
     
   • molecular mechanisms of antibiotic resistance,
     
   • biological agents, which potentially can be used as biological weapons (anthrax, plague, smallpox, and hemorrhagic fever viruses).
     
2. Development of new diagnostic tools, therapeutics and vaccines
   
   • A major challenge for biomedical research will be the development of new diagnostic tools, novel antimicrobial agents as well as vaccines against major infectious agents. Especially, the new techniques in molecular biology as well as data gained from genome sequencing projects open new possibilities for the development of useful products. These products should include also new tools, therapeutics and vaccines against infectious agents of potential biological weapons including smallpox, etc.
     
3. Development of infrastructure
   
   • The public health services should be further developed on a national as well as international level. This should also include the institutions involved in the analysis of pathogens in veterinary medicine and agriculture. In addition, containment systems, which should include laboratories of high security infrastructure (BSL-3 and BSL-4), should be further developed.
     
4. Education
   
• It is necessary to educate students, physicians as well public health workers on aspects of infectious diseases including biosafety and biosecurity aspects. This is especially true for pathogens, which have been eradicated, such as smallpox however which may still represent a danger for the society, because of their potential misuse as biological weapons.
  
5. Scientific cooperation
   
   • It is necessary to strengthen the international contacts of scientists working in the field of infectious disease research. Despite the fact that the new situation regarding biosafety and biosecurity makes it necessary to control persons working at least with I. category of infectious agents, the international contact between scientists should be strengthened rather than being restricted.
     
6. Exchange and transfer of biological agents and toxins
   
   • For scientific use, it is necessary to exchange scientific material including bacteria, viruses, recombined DNA, toxins, etc. It is necessary to control exchange of material, which includes high pathogenic biological agents. This is especially true for the methods of weaponization. A quick and unbureaucratic exchange of material across borders, however, is still necessary.
     
7. Publications
   
   • Publications, also those concerning infectious disease research should continue to be open to the public. There is, however, a very minor fraction of the so-called "dangerous information" regarding high pathogenic biological agents and high toxic toxins and their weaponization. This situation represents a specific challenge for editors and publishers, which should develop specific rules for this type of information. In general, the exchange of ideas including publications should continue to be open on the national as well as on the international level, taking the aspects of misuse into account.

           To minimize the risk of dual-use it may be or will be necessary to restrict publication of data, which immediately and feasibly could lead to such misuse. Careful education of students and offensive and special training of graduate students and post-docs is crucial for future protection of scientific sensitive information. Self-control of science and scientists on local, national and global level is also very important.

           The US National Academy of Science proposed very good and important criteria for review before publication of sensitive research information in full detail that include experiments involving microbial agents that raise concerns about their potential for misuse.

They include experiments that:

• Would demonstrate how to render a vaccine ineffective
  (Creation of a vaccine-resistant smallpox virus),
  
• Would confer resistance to therapeutically useful antibiotics or antiviral agents
  (Introduction of ciprofloxacin resistance in Bacillus anthracis),
  
• Would enhance the virulence of a pathogen or render a nonpathogen virulent
  (Introduction of cereolysin toxin gene into Bacillus anthracis),
  
• Would increase transmissibility of a pathogen
  (Altering vector competence to enhance disease transmission),
  
• Would alter the host range of a pathogen
  (Making nonzoonotics into zoonotic agents/Altering the tropism of viruses),
  
• Would enable the evasion of diagnostic/detection modalities
  (Microencapsulation to avoid antibody-based detection and/or the alteration of gene sequences to avoid detection by established molecular methods),
  
• Would enable the weaponization of a biological agent or toxin.

Conclusions

           Research in the life sciences, including NBC defense research must be conducted safely, securely, and ethically.

           Protecting against NBC terrorism must be a global effort.

           Code of conduct should not be regulatory in nature and it should raise the individual's awareness of ethical issues.

           Education of scientific community globally to raise awareness of potential threats as well as highlight ethical issues associated with the conduct of NBC Defense sciences.

           Development of an international harmonized regime for control of biological and chemical warfare agents within and between laboratories and facilities is very important next step.

           Development of systems of review to provide oversight of sensitive scientific research and development of an international norm for the dissemination of sensitive information in life sciences is crucial in future.

           Final solution of Codes of conduct in dual-use research must be acceptable and workable in countries around the world.

References

1. Robert Mathews, "A Model Legislation for the implementation of BWC and UN Security Council Resolition 1540", Australian Defense Science and Technology Organization, 1th Interpol Global Conference on Preventing Bioterrorism, Lyon, France, 1-2 March 2005.
   
2. Hans-Dieter Klenk, "Regulations for the Prevention of Bioterrorism - Pro's and Contra's from a Scientists Point of View", Institut für Virologie, Philipps Universität Marburg, Germany, BTWC Meeting of Experts, Geneva, 13-24 June 2005.
   
3. Philip Campbell, "Dual-use biomedical research, journals and codes of conduct", BTWC Meeting of Experts, Geneva, 13-24 June 2005.
   
4. Kathryn Nixdorff, "Codes of Conduct and their Application in the Life Sciences at Universities", Department of Microbiology and Genetics, Darmstadt University of Technology, BTWC Expert Meeting, Geneva, 13-24 June 2005.
   
5. Alastair Hay, "The roles of codes of conduct in preventing the misuse of scientific research", BTWC Meeting of Experts, Geneva, 13-24 June 2005.
   
6. Thomas Holohan, Executive Director, NSABB Office of Biotechnology Activities National Institutes of Health Department of Health and Human Services, "Codes of Conduct for the Life Sciences: Past, Present, and Future"; "The National Science Advisory Board for Biosecurity (NSABB): Enhancing Oversight of Dual Use Research", BTWC Meeting of Experts, Geneva, 13-24 June 2005.
   
7. Richard Weller, "Developing an Acceptable Code: A Code of Ethics", Pacific Northwest National Laboratory U.S. Department of Energy, BTWC Meeting of Experts, Geneva, 13-24 June 2005.