Biosecurity — Freedom and Responsibility of Research

Deutscher Ethikrat Biosecurity — Freedom and Responsibility of Research OPINION Deutscher Ethikrat Biosecurity — Freedom and Responsibility of Research OPINION 7 May 2014 Published by the German Ethics Council Jaegerstrasse 22/23 · D-10117 Berlin Phone: +49/30/20370-242 · Fax: +49/30/20370-252 Email: [email protected] www.ethikrat.org © 2014 Deutscher Ethikrat, Berlin Title of the original German edition: Biosicherheit – Freiheit und Verantwortung in der Wissenschaft All rights reserved. Permission to reprint is granted upon request. English translation: Charles Warcup Layout: Torsten Kulick Cover design: BartosKersten Printmediendesign, Hamburg ISBN 978-3-941957-63-3 Contents 1 INtrodUctION 9 1.1 Grounds for the Opinion 9 1.2 Fundamental terms 11 1.3 Historical background 18 2 BIosecURITY-relevaNT FIELDS OF research 26 2.1 Infection biology 26 2.2 Bioinformatics 28 2.3 Genome research 29 2.4 Systems biology 30 2.5 Nanotechnology 32 2.6 Neurosciences 33 2.7 Synthetic biology 35 2.8 Do-it-yourself biology and biohacking 38 2.9 Targeted delivery technologies 40 3 AssessmeNT OF THE RISKS 43 3.1 Exemplary scenarios and criteria for hazard assessment 46 3.2 Conclusions 51 4 ETHICAL QUestIONS SUrroUNDING BIosecURITY-relevaNT research 53 4.1 The scientific ethos and scientific answerability 55 4.1.1 Advancement of scientific knowledge and technical implementation in the life sciences 55 4.1.2 The normative self-regulation of modern science 58 4.1.3 Individual entitlement and societal obligation to carry out research 61 4.2 Ethical appraisal of the risks of life sciences research as a necessary basis for responsible action 62 4.2.1 Uncertainty and inequality as elements of modern technology and science 63 4.2.2 The ethical scope of risk assessments 64 4.2.3 On the ethical reconstruction of the term security 69 4.3 Dealing with uncertainty — the precautionary principle 72 5 4.4 Dealing responsibly with biosecurity risks in the life sciences — the ethical dilemma of Dual Use Research of Concern 79 5 LEGAL frameworks for DUAL Use research IN GERMANY 82 5.1 Constitutional premises 82 5.1.1 Academic freedom 82 5.1.2 Restrictions on biosecurity-relevant research 84 5.2 International Law and European Law: premises and influences 88 5.2.1 Specifically biosecurity-relevant international agreements 88 5.2.2 Guarantees of the Charter of Fundamental Rights of the European Union, regional and universal human rights treaties 93 5.2.3 Liability according to international law 95 5.3 Directly applicable European Union law and the sub-constitutional legal situation in Germany 96 5.3.1 Export controls according to the EC Dual Use Regulation 96 5.3.2 National special laws 98 5.4 Conclusions 106 6 Research FUNDING 109 6.1 Basic principles and limitations of research funding in Germany 109 6.2 Direction of research funding in the EU 110 7 Codes OF coNDUct IN GERMAny — INSTRUMENts OF SELF-resPONSIBILITY 116 7.1 Codes of conduct laid down by scientific organizations in Germany 118 7.1.1 German Research Foundation: ‘Code of conduct: Working with highly pathogenic microorganisms and toxins’ (2008/2013) 119 7.1.2 Max Planck Society: “Guidelines and Rules on a responsible approach to freedom of research and research risks” (2010) 122 7.1.3 Leibniz Association: Code of Conduct for Biosecurity for Facilities dealing with Biological Resources (2012) 125 7.1.4 Central aspects of the codes of conduct in comparison 127 7.2 Codes of conduct in research and freedom of research 132 7.2.1 Constitutional aspects of the codes of conduct issued by scientific organizations 132 7.2.2 The form and degree of bindingness of codes of conduct in research 134 6 7.3 Codes of conduct of private sector organisations 135 7.3.1 BIO Deutschland: Position Paper (2008) 135 7.3.2 Voluntary commitments in the genetic synthesis industry 136 7.4 Conclusion 139 8 Selected EXAMPles ILLUSTRATING how BIosecURITY-relevaNT research IS HANDLED IN other coUNTRIes 141 8.1 USA 141 8.1.1 Overview and historical development 141 8.1.2 Codes of conduct in the USA 145 8.2 The Netherlands 147 8.3 United Kingdom 153 8.4 Conclusions 154 9 THE NEED for basIC, advaNCED AND coNTINUING EDUCATION IN THE AREA OF BIosecURITY 155 10 NormatIVE coNCLUSIONS 159 10.1 Normative principles for the assessment of biosecurity-relevant research 159 10.2 The justification of risk management measures for the sake of biosecurity 161 10.3 Ensuring the transparency of assessment processes 164 10.3.1 Stakeholders 164 10.3.2 Balancing of interests and criteria 165 10.3.3 Averting danger and risk mitigation 168 10.3.4 Risk management instruments 170 11 SUMMARY AND RecommeNdatIONS 176 APPENDIX I. EXAMPles OF factors INvolved IN THE assessmeNT OF DURC 189 I.1 Examples of DURC-relevant microorganisms and toxins 189 I.2 Examples of DURC-relevant experiments 192 REFERENces 195 GlossarY 214 ABBREVIATIONS 217 7 1 INTRODUCTION 1.1 Grounds for the Opinion In 2012, a group of researchers in the USA and another in the Netherlands produced mutated variants of the avian influenza virus H5N11 that, in contrast to the wild type, could be trans- mitted between mammals (ferrets) through airborne transfer.2 To date, H5N1 infection has rarely occurred in humans, and then only following close physical contact with infected poul- try or contaminated surroundings.3 However, where infection occurs the results are frequently fatal. The aim of the research projects was to identify mutations that render the virus more easily transmissible between humans and therefore perhaps more dangerous for humans, with a view to achieving a better state of preparedness for such changes that might occur in nature. The studies provoked a general debate as to whether experiments designed to make a pathogen more dangerous should be encouraged at all, whether it is permissible to conduct them and publish their findings and whether it may be appropriate to place limitations on them to prevent the unintentional release of pathogens from laboratories as well as misuse, for example by bioterrorists.4 Both manuscripts were examined by the US National Science Advisory Board for Biosecurity (NSABB) prior to publication. The NSABB initially recom- mended withholding important methods and data contained in the manuscripts from publication for security reasons and 1 The avian influenza virus belongs to the influenza A set of viruses. The des- ignation influenza A/H5N1 refers to the specific variations of the proteins haemagglutinin (HA) and neuraminidase (NA) that contribute significantly to the infectivity of the virus. 2 Cf. Herfst et al. 2012; also Imai et al. 2012. 3 Cf. World Health Organization 2013a. 4 For a description of the studies, the debate and the differences of opinion to which it led, see Fauci/Collins 2012. 9 to prevent misuse. This recommendation in turn was the ini- tiator of public discussions, mainly in the USA and Europe- an states, that addressed fundamental questions concerning freedom of research and possible justifications for restricting it. Following a period of consultation, the World Health Or- ganization (WHO) reached a position, whilst expressing mis- givings, in favour of complete publication,5 and the NSABB changed its original recommendation, finally agreeing to publication of the manuscripts in revised form6. Nevertheless, these developments raised questions involv- ing appropriate rules for the funding, monitoring and publication of dual use research of concern,7 and set international discussion processes in motion.8 For instance, from January 2012 until January 2013, influenza researchers suspended research that could make avian influenza more dangerous, declaring a voluntary moratorium in order to discuss the way to proceed.9 In the USA, the research that has now resumed has become subject to new regulations on biosecurity (cf. Section 8.1.1).10 A conference organized by the WHO in 2013 on the question of how to deal with dual use research of concern concluded, amongst other things, that there was a need for continuing de- liberation on the matter.11 In Europe, scientific associations and virologists ap- proached the President of the EU Commission and the Commissioners responsible for research, health, justice and 5 Cf. World Health Organization 2012a; cf. National Science Advisory Board for Biosecurity 2012. The WHO conference attracted a degree of criticism as being an assembly biased towards the areas of public health and influenza research, without a representative number of biosecurity experts. Some observers regarded it therefore to be a foregone conclusion that the main results of the meeting provided, on the whole, support for the scientists in their desire to pursue the H5N1 experiments further. Cf. Kelle 2012. 6 American Association for the Advancement of Science et al. 2012, 10. 7 Cf. Kelle 2012. Cf. also Nature Publishing Group 2013 and Maher 2012. 8 Cf. for example Royal Society 2012a; or also Matchett/Mazza/Kendall 2013. 9 Cf. Fouchier et al. 2012. 10 For a detailed treatment of the questions surrounding research on influenza viruses that remain the subject of debate, and how it is being discussed especially in the USA, see Matchett/Mazza/Kendall 2013. 11 Cf. World Health Organization 2013b. 10 consumer protection in December 2013 and called for an international conference to be held with the aim of establishing a scientific foundation for the political and legal decision- makers in the EU and its member states with respect to such experiments, and developing better means of estimating the associated risks and benefits of such research.12 Prompted by the current discussion, and in view of the complexity of the legal, ethical and political questions raised by biosecurity-relevant research, the German Federal Govern- ment commissioned the German Ethics Council to draft an Opinion on the subject of biosecurity and freedom of research.

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