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Science, People & Politics ISSN: 1751-598x online. Issue 2, V III, 21st April, 2012. Pre published 20/4/12. Republished 27/2/16.

Simon Whitby

Endnotes

In his article "Biological Indecision", on 9th January 2012 in the Bulletin of the Atomic Scientists¹, Malcolm Dando laments a missed opportunity in December 2011 to strengthen the Biological Weapons Convention (BWC) - the international legal prohibition against biological weapons.

However, as this paper argues, the outcome of the seventh review conference in 2011 of the BWC presents civil society with a series of potentially significant intervention points where contributions from scientists and educators on best practise in both areas can be reported to State Parties on an annual basis. It is therefore vital that top-down, State Party endorsement has been agreed in regard to the importance of considering these issues over the next five years. Indeed, such interventions may contribute to the preservation of much-valued academic and scientific freedoms.

Although States Parties to the Biological Weapons Convention (BWC), which entered into force in 1975, had previously (1997-2002) failed in their negotiations to agree a Protocol for verifying compliance, the intersessional processes between the fifth (2001/2002) and seventh (2011) BWC review conferences had been productive, and hopes and expectations for a positive outcome to last December's seventh review conference were high.

Top-Down Initiatives to Strengthen the BWC
The Final Declaration² of the seventh review conference endorsed the common understanding reached during the 2007 to 2012 intersessional meetings, and included an affirmation of the utility of the annual sequence of Meetings of Experts, followed by Meetings of States Parties, for conduct of the intersessional programme between 2012 and 2016. However, in a break with convention, it was agreed that the inter review-conference process between the seventh and eighth review conferences would see the consideration of Standing Agenda items on an annual basis.

Notably, in regard to Standing Agenda items, under Section III, "Decisions and Recommendations³" (page 20), Part D³ (page 23) contained a commitment to review annually "Developments in the field of science and technology related to the Convention". Under Part D the following topics inter alia would be addressed:

a: new science and technology developments that have potential for uses contrary to the provisions of the Convention;
c and b ommitted here.
d: voluntary codes of conduct and other measures to encourage responsible conduct by scientists, academia and industry;
e: education and awareness-raising about risks and benefits of life sciences and biotechnology.

Although consideration by States Parties of scientific and technological developments and their relevance to the Convention (a) has been part of the five-yearly, review-conference process, the submission of working papers on science and technology was not mandatory, the quality of contributions from States Parties varied, and such periodic reviews could not keep pace with the rapid pace of change in this area.

Related to the latter, and in regard to (d), is the need to identify strategies for improving the voluntary oversight of life- and associated science research. Of particular concern was the dual-use potential innate in life- and associated science research. As set out in the 2010⁴ report by the US National Research Council (N.R.C.) of the National Academies, "Understanding Biosecurity: Protecting Against the Misuse of Science in Today's World", dual-use is defined as a concept that is "...related to biosecurity, [where] research intended for legitimate purposes may also have a potential to be misused in the development of bioweapons". Such concerns were discussed in detail under the auspices of the BWC in 2005 and again in 2008, when consideration was given to strengthening the in-depth national implementation of the Convention by development and implementation of biosecurity oversight systems for research projects and publications and codes of conduct.

The agreement by States Parties in December 2011 on the value of considering on an annual basis "(e) education and awareness-raising about risks and benefits of life science and biotechnology", also builds on a consensus on the importance of awareness-raising and education that emerged from the 2008 meeting of States Parties.

Whilst the consideration of science and technology, oversight, and education and awareness-raising represent only a series of modest incremental steps in the overall process to strengthen the BWC, such developments are significant in that their annual consideration keeps the issues high on the agenda of States Parties, where subsequent agreement on concrete measures could be translated into effective action at the eighth review conference of the Convention in 2016. Legally-binding agreement on these issues in 2016 could place the 164 States Parties to the Convention under an obligation to enact necessary national measures, particularly in regard to oversight of benignly intended scientific research, and awareness-raising and education.


BOTTOM-UP INITIATIVE TO STRENGTHEN THE BWC
Life- and Associated Science and Oversight
Where other arms control negotiations have been characterised by significant civil society input, such as the Landmine⁵ and Cluster Munition⁶ negotiations, for example, where hundreds of N.G.Os and civil society groups made significant contributions to each of the respective processes, civil society's involvement in the process to strengthen the BWC has been comparatively modest⁷, with only limited representation from science industry (pharmaceutical), professional life-science societies and associations (biosafety), academia (Universities of Bradford, Bath, Exeter, LSE, Sussex) and non-governmental organisations (VERTIC, the Landau Network Centro Volta, and US National Academies etc).

As well as improving the quality of the science and technology review process, increased civil society input into the BWC from life- and associated sciences, including both contributions from individuals, as well as scientific societies and professional associations, could also make a significant contribution to the articulation of sensible measures to develop oversight for life- and associated science, in a way that would be most effective in preserving academic and scientific freedom. If representation for life- and associated sciences is significant, such bottom-up interventions may also serve to militate against the stifling of innovation in life science.

The forthcoming intersessional process presents civil society with a range of opportunities within which to explore biosecurity challenges thrown up by benignly intended innovations in the life- and associated sciences, and to build on a biosecurity discourse which dates back to the anthrax attacks in 2001. That debate has tended to coalesce around experiments of dual-use concern. A number of paradigm cases of experiments of dual-use concern have emerged, and the discourse is characterised by an action-reaction dynamic, with national security concern following publication in the open scientific literatue, followed by significant attention in the popular scientific press, followed by calls for improvements to scientific oversight. In some cases serious issues have been raised about responsible conduct of life- and associated science research, and the relationship between science and society has been brought into question.

Paradigm cases could include: the chemical synthesis and generation of infectious poliovirus in the absence of natural template⁸, that is, the creation of a virus in a laboratory utilising synthetic biology, rather than from live virus; the recreation, also reported in Science⁹, of the devastating 1918 Spanish influenza virus; and the killer virus, mouse-pox¹⁰, as reported in the Journal of Virology. Seumas Miller and Michael Selgelid^10b are among authors exploring concepts related to such paradigm cases.

Each of the above cases are examples of the culture of openness in life- and associated sciences, where materials, methodologies and results are made available to all via the open scientific literature. The most recent example of dual-use, life science research of concern relates to research on H5N1 Avian Flu virus¹¹, which resulted in the creation within the confines of a laboratory of an airborne virus which was both potentially lethal and possibly highly contagious. News media reports provoked a fierce debate among biosecurity experts, life scientists and ethicists, regarding the rationale behind both the conduct of the experiment, and the wisdom of publishing its findings in the open literature.

Although the US National Science Advisory Board for Biosecurity (NSABB) had in 2011 "unanimously recommended"¹² that "key details"¹³ would be withheld so that the manuscripts could be published in redacted form, N.S.A.B.B. subsequently reversed its position following a two-day meeting to reconsider the two manuscripts.


Biosecurity debate after 9/11
Following 9/11 and the anthrax attacks in 2001, an intense debate about biosecurity led to a range of responses intended to mitigate against the hostile misuse of life-science research. Kelle notes, in particular, the "securitisation" of the US Public Health System as a first line of response, with the latter resulting in what some see as the distortion of health care priorities to counter a threat that is over-exaggerated. The early 2000s also saw the reorganisation of domestic security arrangements in the US, alongside the enactment of new national legislation to combat bioterrorism, with the creation of the Department of Homeland Security and the entry into force of the US Patriot Act¹⁴.

A high profile court case¹⁵ concerning the illegal importation of plague microorganisms brought the activities of life scientists under the public spotlight. Measures issued by both the N.I.H. (National Institutes of Health) and the U.S.D.A. (US Department of Agriculture) relating to the handling and transportation of select agents followed. And in the wake of the publication of the above experiments of dual-use concern the editors of some of the world's leading life- and associated science journals, as well as professional associations and scientific societies, submitted a joint declaration titled, "Statement of Scientific Publication and Security", which was published simultaneously in the pages of Science, Nature¹⁶, and the Proceedings of the National Academy of Science (P.N.A.S), and also by the American Society of Microbiology. The statement highlighted the importance of implementation of appropriate review processes for the consideration of such research prior to its publication. Finally, a series of studies in the US had considered ways in which guidelines might be devised for the oversight of scientific research, with the 2004 Fink Report¹⁷ "Biotechnology Research in an Age of Terrorism" recommending the creation of the National Science Advisory Board for Biosecurity (N.S.A.B.B.).

The mandate given to N.S.A.B.B.¹⁸ was to develop guidelines for the "...oversight of dual-use research, including guidelines for the risk benefit analysis of dual-use biological research and research results". N.S.A.B.B., however, recommended focusing on a narrow subset of life science research of dual-use concern which had the "...highest potential for yielding knowledge, products, or technology that could be misapplied to threaten public health or other aspects of national security". This system contrasted sharply with the system of oversight developed by researchers at the University of Maryland which, for example, placed emphasis on a top-down regulatory system of licensing individual researchers. Although N.S.A.B.B's approach placed responsibility for the evaluation of dual-use research of concern with Principal Investigators (P.I.), one possible flaw in this bottom-up approach to scientific oversight would relate to the biosecurity awareness level of the P.I. presiding over the evaluation, and the extent to which they are capable of judging whether research of dual-use concern had the potential to be misapplied to threaten public health or national security.

N.S.A.B.B. would consider ways in which the perceived deficit in biosecurity awareness-raising and education among the life- and associated science communities could be addressed, and in its 2008 report, "Strategic Plan for Outreach and Education on Dual Use Research Issues"¹⁹, the Board set out a series of recommendations "on the development of programs for outreach, education, and training on dual-use research issues for all scientists and laboratory workers at federally funded institutions". Indeed this report acknowledged that levels of awareness of dual-use issues would be "fundamental to any successful system of oversight". Such a system, N.S.A.B.B. argued²⁰, "would depend on the ability of researchers to recognize the dual-use potential of their work and to consider options on how best to minimize the risk that their findings may be misused or misapplied toward malevolent goals".

There are few examples, however, even in advanced industrialised developed countries, where calls for beyond the laboratory door biosecurity awareness-raising and education for life- and associated sciences have translated into decisive action. One example has emerged in Canada from the implementation in 2009 of the Human Pathogens and Toxins Act (HPTA)²¹, which specifies that biosafety professionals should be appropriately qualified. The purpose of the Act is to establish a "...safety and security regime to protect the health and safety of the public against the risks posed by human pathogens and toxins." To comply with the Act, the Public Health Agency of Canada (PHAC) is committed to the development of a hybrid accredited course in biosafety and applied dual-use beyond the laboratory door.


AWARENESS-RAISING AND EDUCATION
Between 2002 and 2008, colleagues from the UK Universities of Bradford²² and Exeter²³ and from the Italian Landau Network Centro Volta²⁴ had conducted a series of investigations²⁵ into levels of biosecurity awareness, and into the existence of education provision about biosecurity awareness for life- and associated sciences in universities. The investigations²⁶ into levels of dual-use biosecurity awareness among life scientists suggested an urgent need for awareness-raising and for educational initiatives to engage life- and associated sciences in a dialogue to address the ethical, legal, and social concerns raised by their research, and to underline the importance of fostering a culture of responsible conduct of research that would help mitigate against the potential for misuse of benignly intended research.

Though it came as some surprise, given statements made at the five-year review conferences²⁷ of the Convention about the need for awareness and education of the Convention, few life scientists around the world had knowledge of the Convention or of their responsibilities under it. Work by the Bradford Disarmament Research Centre (B.D.R.C.)²⁸, and other organisations, demonstrated that one major reason for this ignorance among life- and associated sciences was that the BWC and the related prohibition against chemical weapons²⁹, as well as a range of other international and national security regimes, were not covered by university education.

Building on this finding, the Bradford Centre and Japan's National Defence Medical College³⁰ constructed an open-source educational module resource (E.M.R.)³¹ to help lecturers incorporate such material into their courses. The E.M.R. consists of 21 lectures that can in full or in part be assimilated into teaching dual-use biosecurity to others. The latter has been backed up by a train-the-trainer course, as well as a series of national-specific short courses.

With dual-use the subject of an expanding discourse³², and since discussion about life-science experiments of concern have been framed in terms of dilemmas³³, it is not surprising that ethicists have entered the dual-use biosecurity debate. Although deliberation about dual-use research by ethicists has been limited, and much of this work thus far has focused on the role of individual scientists working on dual-use as noted by Selgelid³⁴, there is nevertheless an emerging ethics discourse, explicitly relating to the problem of dual-use science and technology.

In the context of this discourse, discussion relating to a pedagogy for dual-use biosecurity has received little attention, and the utilisation of ethical approaches in teaching is both limited and poorly conceptualised, and largely consists of approaches borrowed from other areas of ethics pedagogy. In the absence of best practice in this area, discussion about an ethics of biosecurity have tended to operate at basic and intermediate levels³⁵. Discussions have centred around concepts borrowed from normative moral philosophy, from applied research ethics and from procedural ethics, and at a basic level there is a tendency to approach education from the perspective of the need to convey to learners an understanding of concepts such as, autonomy, duty (deontology), justice, rights, utility (teleological and consequentialism), and virtue. Indeed writers operating at the interface between philosophy and biosecurity, such as Briggle³⁶, Ehni³⁷, Kulau³⁸, and Selgelid and Miller³⁹, have made particular contributions to the ethics of dual-use with discussion that have focused on explanatory frameworks such as the precautionary principal and the doctrine of double effect, and these too have been incorporated into teaching ethical deliberation in dual-use biosecurity. At intermediate level, dual-use biosecurity scenarios, based on real-world ethical dilemmas such as the above mentioned paradigm cases of experiments of dual-use concern, can be utilised in practical, interactive teaching to facilitate deliberation by life- and associated scientists about real-world, dual-use biosecurity dilemmas. Normative ethical concepts can be deployed in teaching and learning that is both realistic and safe, and online virtual learning technologies utilised.

A case study approach can adopt procedural approaches to ethical decision-making. In this connection, a number of models exist, including that produced by the Hastings Centre⁴⁰, which sets out a six-stage model for facilitating deliberation and decision-making, including the following:

1: identification of the ethical problems raised;
2: collating and assessing the facts relevant to the decision;
3: identification of stakeholders in case;
4: identification of the values at stake in the case;
5: identification of possible solutions, and considering options for alternative solutions, and;
6: conducting an evaluation of the process of decision-making.

Applied practical approaches to teaching can be conceived combining both basic and intermediate levels, and if effectively implemented and placed in the context of targeted and carefully articulated learning outcomes, a mix of traditional academic teaching and assessment with traditional individual academic assignments and practically-oriented group-work can be utilised in approaches to teaching and learning in this area. Metrics can be deployed to show how awareness-raising and education in dual-use biosecurity at both basic and intermediate levels can be improved over time, for example throughout the duration of a teaching module. The scenario set out above for a pedagogy of dual-use biosecurity could form the basis for the articulation of a standard of "competence" in this area of teaching and learning, one which is complementary to the biosafety standard set out in the C.E.N. Agreement⁴¹.

In spite of widespread and increasing support for the introduction of awareness-raising and education about the potential for the destructive application of life- and associated sciences, once again there are few examples of accredited courses that offer the kind of qualifications that are being sought by Canada's Public Health Agency. The Bradford Disarmament Research Centre's train-the-trainer module is, however, one example.
The module builds on the initiative to devise an education module resource (E.M.R.) as described above, and it incorporats basic and intermediate approaches to an ethics of biosecurity into a course which:

covers the wider discourse on dual-use;
exposes course participants to the history and evolution of the relevant prohibition regimes;
provides an appreciation of the role of life- and associated sciences in the deliberate use of disease in offensive biological weapons programmes;
clarifies the importance of a "web of prevention"⁴² that places biosecurity in the context of an overlapping, but complementary, web of preventative measures.

Enrolment on the Bradford train-the-trainer module provides an opportunity for engagement with issues of key importance to the development of competency in applied dual-use biosecurity education and enables development of analytical and policy-oriented awareness, of relevant thinking and writing skills, and practical deliberation involving real-world, dual-use dilemmas.


THE TRAIN THE TRAINER COURSE AIMS
1. Introduce participants to the concept of bioethics in so far as it relates to the broader issue of biosecurity.
2. Develop awareness and understanding of a range of dual-use conundrums and ethical dilemmas that arise from the impact of science and technology on society.
3. Develop awareness and understanding of the ethical, legal and social relevance of dual-use biosecurity.
4. Develop knowledge of approaches to the responsible conduct of research and other work, and provide the trainer with the knowledge and skills that enable the justification for decisions or recommendations regarding dual-use technologies.

In terms of knowledge and understanding, on successful completion of this module participants would be able to:
Critically evaluate and analyse the ethical and social responsibilities of life- and associated scientists, with reference to the responsible conduct of research and other work; and
critically evaluate and analyse the legal responsibilities of life- and associated scientists, with reference to international legal prohibitions and national laws and guidelines.

In terms of discipline skills, on successful completion of this module participants are able to:
organise and synthesise ideas and questions relevant to responsible conduct of research and other work in specific dual-use issues affecting humans, animals and plants;
contribute to the development and implementation of relevant country-specific and institutional mechanisms, guidelines, regulations and legislation; and
integrate responsible conduct of life- and associated science research and other work relating to dual-use biosecurity issues and concerns into the training of others.

In terms of assessment, a mixed approach is applied. Participants are required to submit traditional written assignments, but in this regard a practical approach has been adopted with participants being required to produce a "reflective, applied written individual assignment". Course participants are free to choose the topic of their reflective assignment, but the exercise is designed to get the participant to reflect on their own experience as a P.I., as a biosafety professional, or as a life- and associated science professional working in an appropriate setting. The reflective assignment asks the participants to provide a record of their personal experience in confronting, handling and seeing through to completion a task that has represented a professional biosafety and/or biosecurity challenge because of the biosafety and dual-use biosecurity questions that the issue has raised. To assist participants in the reflective aspect of the assessment, the following guidelines are provided, which requires that the participant:
a. describe the nature of the biosafety and biosecurity issue they have confronted;
b. relate the issue to dual-use biosecurity concerns that have been raised during the course of the applied dual-use, biosecurity-education train-the-trainer course;
c. utilise the literature from the dual-use biosecurity discourse to contextualise the personal and professional biosecurity challenge, and where appropriate use examples, either from the lectures or from the expert-level scenarios that have been discussed on the course;
d. consider, where relevant, the ethical, legal and social implications that the challenge raises;
e. explain how you resolved the biosecurity challenge you confronted, explaining, where appropriate, how the challenge was resolved in respect of relevant ethical, legal or social issues;
f. relate the biosecurity challenge to the open-source information provided in the education module resource (E.M.R.);
g. demonstrate how the material from the E.M.R., together with the lessons learned from your own biosecurity challenge, could be incorporated into the training of others.

Additionally, from the range of dual-use dilemmas that are introduced during the course of the module, participants are asked to work with colleagues in a group. During this part of the assessment participants are organised into groups consisting of participants located in different countries, with a remit to produce and present as a group an online powerpoint presentation, and subsequently a joint 2000 word report on the group-work findings. Participants are required to give an overview of a real-world, dual-use biosecurity dilemma, and are expected to elaborate on, and give justification for, how the dual-use dilemma was resolved. By referring to the E.M.R., the joint report details how participants would utilise the information from the E.M.R., with examples of how the material might be used in the training of others.

Conclusion
Further engagement between life- and associated sciences and national security communities will help strengthen the norm of non-use of science and technology for hostile purposes among the communities confronting such issues as part of their professional working life. Significant improvement in the involvement of the life- and associated science communities in the process to strengthen the Biological Weapons Convention would bring a constituency, which has previously remained poorly engaged, into the process of considering the implications of developments in science and technology for the Convention. Expertise could also be targeted at bottom-up initiatives to develop sensible oversight of life- and associated science research, and mitigate against top-down regulatory responses that might serve to restrict academic and scientific freedoms in these areas. What will no doubt strengthen the position of life- and associated sciences to improve the quality of their contributions, to both the former and the latter, is awareness-raising and education that develops a full appreciation of the ethical, social and legal responsibilities that are incumbent upon professionals in these areas.

Dr. Simon Whitby is a political scientist, and he lectures at the University of Bradford.
Simon Whitby asserts the moral rights, acknowledged by the publisher, GavaghanCommunications, to be known as the author of this article.
Copyright Simon Whitby, except that the University of Bradford reserves to itself the right to publish this article on its own website no sooner than one month after final publication in Science, People & Politics. This is a publishing agreement unique to this particular article.
This article was received on 30th March, 2012, in response to a commission, and accepted for publication by the editor and editorial advisors 15th April, 2012.
Editor: Helen Gavaghan.

PUBLISHER: Gavaghan Communications

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