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Critical Guidance: A Code of Conduct for Biodefense Scientists
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Roger Roffey, John Hart, and Frida Kuhlau

When representatives of up to 155 states-parties meet in Geneva from November 20 to December 8 to consider ways to strengthen the 1972 Biological Weapons Convention (BWC), they are likely to express support for the promotion and creation of “codes of conduct.” These ethical principles are intended to increase scientists’ awareness and accountability and reduce the risk that biological research and development could be misused for biological weapons.

Yet, producing concrete guidelines for scientists involved in such a broad research area has proved difficult. For example, a June 2005 BWC meeting of experts charged with addressing the adoption of codes of conduct for scientists did not produce any concrete actions.[1]

In fact, it is not realistic to believe that a single broad code can be enacted. States-parties negotiators would be better off focusing on creating a narrower set of guidelines and appropriate oversight mechanisms that would govern a far smaller group of scientists in national biodefense research and development programs, including programs for bioterrorism preparedness and protection. These guidelines could be incorporated into and complement an already existing set of politically binding confidence-building measures, an annual set of national declarations that seeks to build transparency in fields related to the BWC.

Biodefense and the BWC

Although outlawing offensive biological weapons activities, the BWC permits biodefense research and development to develop antidotes and other means of countering biological weapons threats. Yet, the boundary between defensive and offensive biological weapons programs can be hazy. Because it is impossible to know which threats will actually materialize, scientists might carry out research and development activities that arguably could contribute to offensive biological weapons programs.

Moreover, because determining the intentions of other states or nonstate actors is inherently problematic, many intelligence evaluations focus on worst-case scenarios of others’ capabilities. This, in turn, can result in a practically unlimited number of threats and an open-ended demand for resources to evaluate and meet them, especially with regard to possible threats posed by nonstate actors. For example, scientists might develop and test pathogenic strains with modified characteristics, such as resistance to multiple antibiotics or vaccines; or they might replicate, develop, or test new biological munitions or different methods for delivering them. Such activities or the suspicion that they are taking place inevitably cause states to worry that others are carrying out inappropriate research.

These concerns have grown in recent years as a number of states have expanded their biodefense work. U.S funding for bioweapons prevention and defense increased dramatically after the September 11 terrorist attacks, from $1.6 billion to more than $8 billion requested for fiscal year 2007, which begins October 1. All told, 11 federal departments and agencies have spent more than $36 billion since 2001.[2] While spending at the Department of Defense has increased slightly,[3] spending on civil biodefense programs has soared from $414 million in fiscal year 2001 to a requested $7.6 billion in fiscal year 2005.[4]

Advocacy groups have also raised concerns in recent years about pending congressional legislation to establish a new Biomedical Advanced Research and Development Agency (BARDA) that would serve as a single point of authority within the Department of Health and Human Services for implementing biodefense programs. These groups have criticized provisions in some versions of the legislation to exempt the agency from some Freedom of Information Act provisions requiring public disclosure of the programs. As of July, Congress was still crafting final language on a bill to establish BARDA.[5]

This massive investment in all aspects of biodefense and protection against bioterrorism is unique for the United States. Moreover, the nature and scope of this work in the United States is unclear, leaving some to imagine the worst possibilities. Although the United States has demonstrated significant transparency in its reports to Congress and the BWC, critics have suggested that it has crossed the border between defensive and offensive research.[6]

In Europe, funding has increased as well, although on a much smaller scale as Europeans have not viewed bioterrorism to be as great or as imminent a threat. Moreover, a significant share of funds in Europe has been directed toward improving general public health efforts to fight infectious disease outbreaks and to prepare against possible pandemics rather than toward preventing a bioterrorist attack.

Codes of Conduct and Confidence Building Measures

The BWC calls for countries to provide information annually on their national biological weapons defense research and development programs, including data on past programs stretching back to 1946. The United States provides information about its program annually, but it is only one of a few states that do this. When countries do provide information, it is usually for domestic policy reasons, such as to inform national parliaments, and not for public scrutiny. These reports are not readily available and only distributed to states-parties.[7]

As many consider these biodefense declarations insufficient, states-parties have sought other means of making national programs more transparent. Indeed, such discussions were at the center of seven years of negotiations to strengthen the BWC that broke down in 2001. At that time, the United States, citing national security and commercial interests, announced that it could not support a draft protocol to the treaty that would have included a set of mandatory declarations of activities and facilities and the possibility of on-site visits.[8]

In response to criticism over its decision, U.S. officials as an alternative proposed continuing discussions on a limited set of relevant subjects. This so-called new process was subsequently endorsed by the other BWC states-parties in 2002, and it included a discussion of codes of conduct that would more explicitly state generally agreed-on acceptable behavior. The adoption of such codes is an indicator of responsible behavior and helps to ensure appropriate handling of questionable activities. Further, the process of producing codes involves extensive consultations that raises awareness among scientists and fosters internal consultations. A code can also be a valuable tool for educating students and employees.[9]

Most scientists already work under codes of conduct that govern laboratory standards and safe working practices, but they are often unaware of treaties such as the BWC and Chemical Weapons Convention and how such accords affect their work. The existence of ethical or behavioral guidelines can foster an ethical norm among scientists and strengthen oversight. Yet, codes of conduct for scientists who cover biological warfare-related areas are lacking. Such codes should reinforce the “norm” that biological warfare is unacceptable and provide guid­ance as to how scientists can help prevent it. The United States has proposed that, in the context of the BWC, such a code require generally that scientists use their knowledge and skills for the ad­vancement of human welfare and not for any activities that could be used “for hostile purposes or in armed con­flict.”[10]

A more precise code, however, should also be formalized to help biodefense scientists identify what constitutes offensive research and development and create a mechanism for reporting potential BWC violations should they occur.[11] Instituting such a code would require a firm commitment from scientists, program management, and government but is vital. Although the line between offensive and defensive research will likely change as science advances, many national biodefense programs lack even a basic review of research and development activities. Scientists are also not well informed of the BWC’s restrictions.

Several international and nongovernmental organizations have called for the creation of a global code of conduct or declaration on biological weapons that could involve scientists in current biodefense programs worldwide.[12] In the biodefense area, it would be essential to couple such codes of conduct with independent mechanisms that could provide the necessary oversight to assure the public that a biodefense program is purely defensive.[13] In particular, each institute should establish an independent panel of senior scientists to vet any proposed biodefense work and ensure that it conforms to the established codes of conduct. These panels would then report to an independent national committee.

Canada and Australia already have such mechanisms. Australia has an oversight committee for biodefense work and a code of conduct for scientists in the program. Canada’s national oversight committee annually reviews biological and chemical defense research, development, and training activities undertaken by the Department of National Defense to ensure that these activities are defensive in nature and conducted in a professional manner with no threat to public safety or the environment. The committee members’ appointments are approved by the deputy minister of national defense and the chief of the defense staff on the recommendation of the committee chairperson. Nominations for membership in the Biological and Chemical Defense Review Committee are solicited by the chairperson from the Canadian Society of Microbiologists, the Chemical Institute of Canada, and the Society of Toxicology of Canada. To provide transparency, the committee publicizes its annual reports on its website.[14] A copy is also provided to the Organization for the Prohibition of Chemical Weapons.

Another complementary mechanism that should be required is an independent international authority available to scientists who have qualms about their research or would like to report activities they believe to be unethical or irregular. This “ombudsman” should be affiliated with the United Nations and be under the supervision of independent scientific organizations and/or academies. States should also consider establishing a scientific advisory committee in the framework of the BWC.

Finally, the BWC states-parties should table national papers that describe internal legal review processes for biodefense work, including its role in the interagency consultation and review processes; relevant whistle-blower regulations; and the manner in which such procedures are compatible with rules governing classified work.

Getting Results at the Review Conference

Although the window is closing, states-parties still have time to submit proposals for the upcoming BWC review conference. These proposals could consider a variety of issues—some procedural, others substantive—connected with the content, promulgation, and adoption of codes of conduct and any results from the 2005 experts meetings on these subjects. The conference may, inter alia, adopt a code of conduct, adopt guidelines outlining what a code of conduct should contain, agree on a set of measures or a follow-on process to consider further how best to imple­ment such a code, or simply decide to promote codes of conduct that address specific issues.

To make progress, the scope of these efforts should be relatively narrow. It is not realistic to believe that the conference can develop a broad code of conduct covering biological sciences. In addition, a number of other internationally accepted codes of practice already exist in the field. It would be more feasible and effective for the conference to focus on areas where there could be both a benefit and an additional support for the BWC. For instance, the conference could seek to prevent the potential misuse of science related to potential offensive research or development in state-run biodefense programs or activities.

A far-reaching measure would be for states-parties to agree on a set of follow-on measures or on a process regarding a code of conduct for scientists that results in a legally binding commitment. A more modest but more achievable goal would be for the conference to call on states-parties to report on national codes of conduct and supply the texts of such codes as a confidence-building measure.

After adopting such a measure, states would report on any code of conduct for scientists in the biodefense area, whether there is an independent oversight committee for the national biodefense program, and on other relevant codes of conduct for scientists. States-parties also need to consider if current confidence-building declarations on national biological research and development programs are adequate or if it needs to be clarified that these declarations also include research and development on bioterrorism defenses. And states-parties could describe in their national papers the legal review mechanisms to determine whether their biodefense work conforms to the BWC and if any whistle-blower legislation exists that allows for reporting of activities of concern.

In this way, codes of conduct can be closely tied to the fundamental object and purpose of the convention, increasing the likelihood that states-par­ties will support such efforts. This step would be particularly helpful if such confidence-building measures were mandatory and included a means of clarifying declarations, voluntary exchanges of information, and voluntary on-site visits to build confidence. States-parties might also consider agreeing on an intersessional mechanism to allow states to offer implementation assistance.

Conclusion

Scientists need codes of conduct for guidance and to help them clarify their thinking on difficult ethical questions. Countries have to prove to their parliaments and general public that a biodefense program is purely defensive and that the involved scientists are working in line with openly agreed codes of conduct. Independent national oversight committees are therefore needed to review ongoing biodefense research and development activities. In addition, the international community should design some kind of independent international authority to counsel scientists concerned about how their research or results might be used.

At this fall’s BWC review conference, countries should aid this effort by proposing specific guidelines for codes of conduct covering biodefense research and development programs. States-parties should also seek ways to strengthen the confidence-building declarations under the BWC, such as by adding oversight committees and facilitating reporting on activities of concern. In addition, states-parties should review the current declaration on biodefense programs and make it mandatory. Such measures can help ensure that the search for cures to potential biological weapons attacks does not endanger the BWC in the process.


Roger Roffey is a research director at the Swedish Defence Research Agency’s Division of NBC-Defense. Simultaneously, he has held several related, high-level positions in the Swedish government, including serving as a technical expert for the Swedish Ministry for Foreign Affairs during the negotiations to craft a verification protocol to the Biological Weapons Convention and as the head of the Swedish biodefense research and development program. John Hart and Frida Kuhlau are researchers at the Chemical and Biological Warfare Project of the Stockholm International Peace Research Institute.


 

Proposed Codes of Conduct

Several codes of conduct have been proposed to guide scientists whose research might potentially violate the Biological Weapons Convention (BWC). One proposal put forward by nongovernmental organizations in 2002[1] would clarify that the BWC prohibits the development, production, stockpiling, acquisition, or retention of all microbial or other biological agents or toxins of types and in quantities that have no justification for prophylactic, protective, or other peaceful purposes. In other words, the convention contains no exemption for law enforcement, riot control, or similar purpose. Likewise, it would make clear that the BWC bans the design, construction, or possession for any purpose of delivery mechanisms designed to use biological agents or toxins for hostile purpose or in armed conflict. There is no exemption for peaceful purposes.

In addition, scientists would be advised that constructing novel biological agents, including single-gene changes, for threat assessment is incompatible with the spirit and intent of the BWC and should be disavowed. Similarly, the proposal would steer scientists away from weaponizing active biological agents for defensive purposes. It would also suggest that aerosolization or other dissemination of active biological agents be performed only in fully contained bench-scale environments and only for purposes of detection, prophylaxis, or medical treatment.

An alternative proposed code of conduct[2] calls on any person or institution engaged in any aspect of the life sciences to work to ensure that their discoveries and knowledge do no harm. In particular, its authors suggest scientists refuse to engage in any research intended to facilitate or that has a high probability of being used to facilitate bioterrorism or biowarfare. Additionally, they would guide researchers not to contribute knowingly or recklessly to the development, production, or acquisition of microbial or other biological agents or toxins, whatever their origin or method of production, of types or in quantities that cannot be justified on the basis that they are necessary for prophylactic, protective, therapeutic, or other peaceful purposes.


ENDNOTES

1. Barbara Hatch Rosenberg, “Defending Against Biodefence: The Need for Limits,” BWC Special Paper No. 1, Acronym Institute, January 2003.

2. Margaret A. Somerville and Ronald Atlas, “Ethics: A Weapon to Counter Bioterrorism,” Science, March 25, 2005, pp. 1881-1882.

 

 


 

Debating Definitions

When it comes to codes of conduct and the Biological Weapons Convention (BWC), there can be as much debate about semantics as substance. BWC states-parties have considered the merit of using the term “codes of practice” as opposed to “codes of conduct” because the latter term can be interpreted as applying to individuals only. One suggestion for classification of professional codes is that “ethical codes” aim to be aspirational, “codes of conduct” to be educational and/or advisory, and finally “codes of practice” to be enforceable.[1]

State-parties have also expressed uncertainty as to what constitutes a “program.” Does it mean the collective whole of the various military or civilian research and development activities, including individual projects carried out by defense contractors, or only programs carried out by the defense ministry? The BWC confidence-building measures only call for declarations about a “national biological defense research and development program.”

Some activities formerly characterized as biodefense work now fall under bioterrorism. The dis­tinction is important because work carried out as part of a program to meet perceived bioterrorism threats is probably not directed at other states and may thus be perceived as less threatening. Yet, states may seek to hide some biodefense work that is part of an offensive program by characterizing it as part of efforts to meet bioterrorism threats.


ENDNOTE

1. See www.projects.ex.ac.uk/codesofconduct/Examples/index.htm.

 

 


ENDNOTES

1. United Nations, Report of the Meeting of Experts, June 13-24, Geneva, August 5, 2005.

2. Stephanie Chang and Alan Pearson, Federal Funding for Biological Weapons Prevention and Defense, Fiscal Years 2001 to 2007, Center for Arms Control and Non-Proliferation, June 2006.

3. U.S. Department of Defense, Chemical and Biological Defense Program, Annual Report to Congress, March 2005.

4. Ari Schuler, “Billions for Biodefense: Federal Agency Biodefense Funding, Fiscal Year 2001-Fiscal Year 2005,” Biosecurity and Bioterorrism: Biodefense Strategy, Practise, and Science, 2004, pp. 86-96.

5. Jocelyn Kaiser, “Bioshield is Slow to Build U.S. Defenses Against Bioweapons,” Science, Vol. 313, No. 5783, July 7, 2006, p. 29; U.S. House of Representatives draft bill H.R. 5533, “Biodefense and Pandemic Vaccine and Drug Development Act of 2006,” June 6, 2006; and U.S. Senate draft bill S.2564, “Biodefense and Pandemic Vaccine Drug Development Act of 2006,” April 6, 2006.

6. See Susan Wright, “Taking Biodefense Too Far,” Bulletin of the Atomic Scientists, November/December 2004, pp. 58-66; Jonathan Tucker, “Biological Threat Assessment: Is the Cure Worse Than the Disease?” Arms Control Today, October 2004, pp. 13-19; Milton Leitenberg, James Leonard, and Richard Spertzel, “Biodefence Crossing the Line,” Politics and the Life Sciences, September 2004, pp. 1-2.

7. Nicholas Isla and Iris Hunger, “BWC 2006: Building Transparency Through Confidence Building Measures,” Arms Control Today, July/August 2006, pp. 19-22; Nicholas Isla, “Transparency in Past Offensive Biological Weapons Programmes: An Analysis of Confidence Building Measures Form F, 1992-2003,” Occasional Paper No. 1, Hamburg Centre for Biological Arms Control, June 2006.

8. See Rebecca Whitehair and Seth Brugger, “BWC Protocol Talks in Geneva Collapse Following U.S. Rejection,” Arms Control Today, September 2001, p. 26.

9. See The International Committee of the Red Cross, “Preventing Hostile Use of the Life Sciences—From Ethics and Law to Best Practice,” November 11, 2004. See also Interacademy Panel on International Issues, “IAP Statement on Biosecurity,” November 7, 2005.

10. U.S. Department of State, “Working Paper by the United States of America,” Proposal submitted by the United States at the 2001 BWC Review Conference, November 26, 2001, p. 5.

11. Roger Roffey, “Biological Weapons and Potential Indicators of Offensive Biological Weapons Activities,” SIPRI Yearbook 2004: Armaments, Disarmament and International Security ( Oxford: Oxford University Press, 2004), pp. 557-571.

12. Barbara Hatch Rosenberg, “Defending Against Biodefence: The Need for Limits,” BWC Special Paper No. 1, Acronym Institute, January 2003. See also “WMA Declaration of Washington on Biological Weapons,” Doc. 17.400, May 16, 2003.

13. Government of Canada, “Biodefence: Codes of Conduct and Practice,” Paper prepared by Canada at the BWC Meeting of Experts, June 9, 2005.

14. Biological and Chemical Defense Review Committee, Biological and Chemical Defence Review Committee, 2005 Annual Report, Canadian Department of National Defence, October 2005.

 

 

Posted: September 1, 2006