1. INTRODUCTION TO BIOSECURITY AND DUAL-USE Neuroethics Education Module Unit 8

2. OBJECTIVES To provide understanding of how neuroscience may be misused. To understand the concept of the dual-use challenge (in the context of neuroscience), building awareness of how benignly intended research may be subject to misuse, and exploring how the dual-use challenge relates to scientific responsibility. To explain the role of international law as an influence on the conduct of scientific research and its place in the ‘web of prevention’. To promote specific awareness and understanding and the international legal instruments relevant to the dual-use challenge.

3. OUTLINE A. Modern Hostile Applications (Slides A.1-A.4) B. The Dual-use Challenge and Scientific Responsibilities (Slides B.5-B.10) C. The Role of International Law (Slides C.11-C.15) D. International Treaties Relevant to the Dual-Use Challenge (Slides D.16-D.20)

4. A1. Emerging Cognitive Neuroscience and Related Technologies Chart 5-1 – “Aerosols of opioids serve as excellent incapacitants; reversal agents and premedications can be administered to protect soldiers. Russia deployed this technology in the Moscow Dubrovka Theatre in 2002. The agents were probably fentanyl derivatives…” Chart 5-4 – “New nanotechnologies have allowed molecular conjugation or encapsulation that may permit unprecedented access to the brain.” NAS. 2008

5. A2. The Dual-Use Challenge UK Royal Society. 2012. Brain Waves Module 3: Neuroscience, conflict and security. Recommendation 1: – “There needs to be a fresh effort by the appropriate professional bodies to inculcate the awareness of the dual-use challenge (i.e. knowledge and technologies used for beneficial purposes can also be misused for harmful purposes) among neuroscientists at an early stage of their training.”

6. A3. Averting the Hostile Exploitation of Biotechnology(i) “… During the century ahead, as our ability to modify fundamental life processes continues its rapid advance, we will be able not only to devise additional ways to destroy life but also be able to manipulate it – including the processes of cognition, development, reproduction and inheritance. A world in which these capabilities are widely employed for hostile purposes would be a world in which the very nature of conflict had changed. Therein could lie unprecedented opportunities for violence, coercion, repression or subjugation…”

7. A4. Averting the Hostile Exploitation of Biotechnology (ii) “… Unlike the technologies of conventional or even nuclear weapons, biotechnology has the potential to place mass destructive capabilities in a multitude of hands and, in coming decades, to reach deeply into what we are and how we regard ourselves. It should be evident that any intensive exploitation of biotechnology for hostile purposes could take humanity down a particularly undesirable path.”

8. B5. ‘Internal’ Responsibilities of Scientists Professional Ethics Report, 2011: – “Typically… covers nine instructional areas: [for example] (1) Data Acquisition, Management, Sharing and Ownership; (2) Conflict of Interest and Commitment; (3) Human Subjects; (4) Animal Welfare; (5) Research Misconduct; (6) Publication Practices and Responsibilities; (8) Peer Review; (9) Collaborative Science. It is virtually silent, however, on the social responsibilities of scientists…”

9. B6. ‘External’ Responsibilities of Scientists Professional Ethics Reports, 2011: – “… As one of the leading commentators on ethics in science and engineering has observed, ‘Currently, attention to professional responsibility in science and engineering research concentrates more on issues that arise in the conduct of science than in its social influence.’ Scientists must be prepared to consider their responsibilities associated with, for example, emerging technologies…”

10. B7. Responsible Conduct in Dual-Use Research Four papers on ethics and dual-use: – Taking due care: moral obligations in dual use research. Bioethics, 22, 477-487. – A precautionary principle for dual use research in the life sciences. Bioethics, 25, 1-8. – The ethics of disseminating dual-use knowledge. Research Ethics (in press). – Ethical competence in dual use life science research. Applied Biosafety, 17, 120-127.

11. B8. Ethical Competence and Dual-Use Responsibility Applied Biosafety, 17,(3), p.121 – “Ethical competence is strongly connected to responsibility. Without competence, responsibility cannot be taken and without responsibility to take, competence is not needed. Having identified three capacities necessary for ethical competence (awareness, reflection and action), this article now provides an analysis on how these capacities might contribute to a culture of dual use responsibility.”

12. B9. Four Methods for Building Ethical Competence Applied Biosafety, 17, (3), 121-125 Text Boxes – 1. Ethics Education as a Method to Build Dual Use Ethical Competence – 2. Ethics Consulting as a Method to Build Dual Use Ethical Competence – 3. Ethics Rounds as a Method to Build Dual Use Ethical Competence – 4. Ethical Mentoring as a Method to Build Dual Use Ethical Competence

13. B10. Ethical Competence Conclusions Applied Bioethics, 17, (3), 124 – “In this article the concept of ethical competence has been described and applied in a dual use context. Three main conclusions can be drawn from the analysis of dual use ethical competence: 1) it is necessary in developing and sustaining a culture of dual use responsibility; 2) it requires organisational support; and 3) it is insufficient to safeguard all dual use research.”

14. C11. The Web of Prevention Prohibition (in place at both national and international levels) Controls on dangerous pathogens, agents, toxins and chemicals (handling, use, transfer, export) Preparedness, detection, diagnosis, medical counter measures Strong response to any use/threat of use Regulatory responses: treaties, standards, guidelines and codes. Export control groups Early warning systems Oversight of research Verification systems Review of scientific and technological developments Threat anticipation and intelligence Detection, surveillance and response to human, animal and plant disease threats (Laboratory) biosafety and biosecurity Registration and licensing procedures Tracking and documentation of transboundary movements Education, awareness-raising and promotion of a culture of responsibility among scientists Scientific and technical expertise in the security community

15. C12. International Law Some problems are beyond the ability of individual states to address; in these cases states tend to cooperate internationally to more effectively address common concerns. A key form of such cooperation is the development of international law – generally in the form of treaties, conventions, standards and guidelines – to set out expectations for state behaviour. Science is a global endeavour – knowledge, materials, equipment and scientists themselves move rapidly around the globe. Applications and impacts are not limited by national boundaries. Neuroscience is therefore an area in which international law has relevance. This includes the international rules that have been developed to prevent the hostile use of science.

16. BIOTECHNOLOGY REGULATION SECURITY ENVIRONMENT TRADE HEALTH DRUGS CONTROL SOCIAL / ETHICAL IMPACTS E.g. International Declaration on Human Genetic Data E.g. Laboratory Biosafety Manual; International Health Regulations E.g. Trade Related Aspects of Intellectual Property Rights Agreement E.g. Convention on Biological Diversity E.g. Biological Weapons Convention E.g. the United Nations Drugs Conventions C13. Dealing with the Revolution in the Life Sciences

17. C14. Dealing with the Revolution in the Life Sciences – Health Example HEALTH HUMAN ANIMAL PLANT International Health Regulations Laboratory Biosafety Manual Laboratory Biosecurity Guidance Guidance on Safe Transport of Infectious Substances Terrestrial Animal Health Code Terrestrial Manual of Diagnostic Tests and Vaccines Aquatic Animal Health Code Aquatic Manual of Diagnostic Tests International Plant Protection Convention Food and Agriculture Organisation World Animal Health Organisation World Health Organisation

18. C15. Dealing with the Revolution in the Life Sciences – Security Example Biological Weapons ConventionChemical Weapons Convention Convention Against the Use of Environmental Modification as a Method of Warfare 1925 Geneva Protocol Organisation for the Prohibition of Chemical Weapons Intersessional Process (between review conferences) Review Conferences (generally once every five years ) Review Conferences (generally once every five years )

19. D16. The 1925 Geneva Protocol “The right of belligerents to adopt means of injuring the enemy is not unlimited… It is especially forbidden (a) To employ poison or poison weapons.” – 1907 Hague Regulations Concerning the Law and Customs of War on Land The 1925 Geneva Protocol “condemns the use of ‘asphyxiating, poisonous or other gases and of all analogous liquids, materials or devices’ and declares that a prohibition on them is already contained within international treaties. The Parties to the Protocol then agree to ‘extend this prohibition to the use of bacteriological methods of warfare’”. (Rhodes, 2010, p.72)

20. D17. BWC Article I Article I of the Biological Weapons Convention: “Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: 1.Microbial or other biological agents, or toxins whatever their origin or method of production, of types or in quantities that have no justification for prophylactic, protective or other peaceful purposes; 2. Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.”

21. D18. CWC Articles I and II Article I of the Chemical Weapons Convention: “1. Each State Party to this Convention undertakes never under any circumstances: (a)To develop, produce, otherwise acquire, stockpile or retain chemical weapons or transfer, directly or indirectly chemical weapons to anyone; (b) To use chemical weapons…” Article II of the CWC provides a definition of permitted purposes of certain chemicals

22. D18. Main Features of the BWC and CWC Both the Biological Weapons Convention and the Chemical Weapons Convention contain provisions which cover: Not obstructing economic and technological development of states, and ensuring extensive exchange of information, materials and equipment for peaceful purposes (Article X, BWC; Articles VI &XI CWC) Mechanisms for dealing with suspected breaches (VI & VII, BWC and IX & XII CWC) For review of the Conventions to take place, including opportunities to review relevant scientific and technological developments. Only the CWC has provisions on verification (Articles IV, V and Annex on Verification); their absence from the BWC is noted as a problematic weakness. The CWC has an oversight body the Organisation for the Prohibition of Chemical Weapons.

23. D19. Dealing with Scientific and Technological Developments Reports presented to the latest review conferences of the Biological Weapons Convention (7 th Review Conference, 2011) and the Chemical Weapons Convention (3 rd Review Conference, 2013) both contained references to advances in neuroscience likely to be relevant to the Conventions “Since the last review conference, there have been advances in understanding the role of neuroregulators; how to influence psychological states and alter physical performance; as well as linking neurobiology to disease.” – ISU Report to the 7 th Review Conference – Scientific and Technological Developments Relevant to the Convention, p.4.

24. D20. Bottom-Up Approaches to Prevent Misuse “Incorporating Norms in Research Culture Recent years have seen some interesting moves in international organisations and negotiating processes to develop alternative governance initiatives, particularly aimed at closing the gap between scientific and regulatory development. One strand of these focuses on promoting bottom-up ethical governance, through the incorporation of particular norms in scientific research culture, rather than relying solely on top-down governmental implementation of international rules.” Rhodes, 2013.

25. ASSESSMENT QUESTIONS In your field, identify a key area of technology or knowledge that may be open to misuse, and outline what this should imply for conduct in that area. Explain what the dual-use challenge is? What implications does it have for scientific responsibility? Does international law have an important role to play in promoting ethical scientific work? Which international legal instruments and/or processes are relevant to the dual-use challenge in your field?

26. BIBLIOGRAPHY Frankel, MS. And Carlsson, R. “Reshaping responsible conduct of research education”, AAAS Professional Ethics Report, Vol.xxiv(1), Winter 2011. Kuhlau, F. et al. 2012. “Ethical Competence in Dual Use Life Science Research”. Applied Biosafety, Vol.17(3): 120-127. Forge, J. 2008. “Responsible Dual Use”, pp.121-132 in The Responsible Scientist, Pittsburgh University Press. Ehni, H-J. 2008. “Dual use and the ethical responsibility of scientists”, Arch. Immunol. Ther. Exp. 56: 147-152.