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Phd Thesis, School of Law, University of Manchester, P ETHICAL ISSUES IN SYNTHETIC BIOLOGY A thesis submitted to the University of Manchester for the degree of Ph.D. in Bioethics and Medical Jurisprudence in the Faculty of Humanities. 2012 PATRICK HEAVEY SCHOOL OF LAW CONTENTS ABSTRACT………………………………………….………………………….…….6 DECLARATION…………………………………….………………………………..7 COPYRIGHT STATEMENT……………………….………………………………...8 THE AUTHOR…………………………………….….………………………………9 A NOTE ON THE FORM OF THIS THESIS…………………………………….…10 THE SYNTHETIC KINGDOM: A NATURAL HISTORY OF THE SYNTHETIC FUTURE?.....................................................................................................................11 PART I – INTRODUCTION CHAPTER 1: INTRODUCTION TO SYNTHETIC BIOLOGY …....14 INTRODUCTION ………………………………………………..……………….14 SOME IMPORTANT AREAS OF RESEARCH …………….……………..18 DNA Design: Writing Novel Genomes ...........................................................18 The Minimal Microbe Genome ……………………………………………...20 Enhancing the Genetic Code: Could Life-forms Exist that are not DNA Based? ..........................................................................................................22 Building Artificial Cells …….……………………………………………….23 Metabolic (or Pathway) Engineering ……………………………………….25 Living Machines ……………………………………………………………..26 DIY Biology ………………………………………………………………….27 SYNTHETIC BIOLOGY AND TRANSHUMANISM ……………………30 A BRIEF HISTORY OF SYNTHETIC BIOLOGY (AND THE LESSONS THAT CAN BE LEARNED FROM HISTORY) ……..37 THE RESEARCH QUESTIONS …………………………………………...….43 CHAPTER 2: LAW – REGULATION ………………………………….…45 INTRODUCTION………………………………………………….………...45 REGULATION OF SCIENTIFIC RESEARCH……………………………..47 DANGERS OF SYNTHETIC BIOLOGY...…………………………………49 THE CURRENT STATE OF REGULATION………………………………54 THE SYNTHETIC BIOLOGY COMMUNITY DISCUSSES REGULATION……………………………………………………....….55 DIFFICULTIES IN REGULATING SYNTHETIC BIOLOGY...........……..61 REGULATION SHOULD BE INTERNATIONAL IN SCOPE.....................62 WHAT REGULATORY APPROACH SHOULD BE USED….....................66 2 GOVERNMENT STUDIES OF SYNBIO REGULATION.....…………..….72 PRINCIPLES-BASED REGULATION vs. PRESCRIPTIVE RULES……..75 CONCLUSION….…………………………………………………………...77 CHAPTER 3: ETHICAL ISSUES …………………………………………..81 INTRODUCTION………………………………………………………………........81 “IN THE MIDST OF REVOLUTION,” or “FAKING ORGANISMS:” AN OVERVIEW OF THE ETHICAL DISCUSSION……………………….......82 Reports …………………………………………………………………….82 Bioethics Literature and Conference Debates …………………………...97 CONCLUSION……………………………………………………………………..105 CHAPTER 4: RESEARCH QUESTIONS AND METHODOLOGY ………………………………………………………………………………………107 INTRODUCTION: REFLECTIONS ON METHODOLOGY IN BIOETHICS…...107 METHODOLOGICAL APPROACHES TO THIS RESEARCH…………….……112 THE RESEARCH QUESTIONS…………………………………………………...114 PUBLISHED/PUBLISHABLE PAPERS……………………………………….….116 CONCLUSION……………………………………………………………………..120 PART II – SUBMITTED ARTICLES CHAPTER 5: CONSEQUENTIALISM AND THE SYNTHETIC BIOLOGY PROBLEM ……………………………………………………….122 INTRODUCTION…………………………………………………………………..123 EFFECTS ON THE ADVANCEMENT OF SCIENCE……………………………127 EFFECTS ON AGRICULTURE…………………………………………………...140 EFFECTS ON MEDICINE…………………………………………………………147 EFFECTS ON FUEL PRODUCTION……………………………………………...152 BIOSAFETY………………………………………………………………………..160 BIOSECURITY…………………………………………………………………….166 CAN A CONSEQUENTIALIST SUPPORT SYNTHETIC BIOLOGY?.................176 IS A CONSEQUENTIALIST ANALYSIS ADEQUATE?.......................................181 NEWTON, EINSTEIN AND CONSEQUENTIALISM: HAS CONSEQUENTIALISM A FUTURE?.........................................................184 CONCLUSION……………………………………………………………………. 186 CHAPTER 6: A DEONTOLOGICAL ASSESSMENT OF SYNTHETIC BIOLOGY …………...………………………………………..188 INTRODUCTION…………………………………………………………………..189 A CHALLENGE TO THE INTEGRITY OF NAURE?............................................190 3 A CHALLENGE TO THE DIGNITY OF LIFE?......................................................194 “PLAYING GOD” – A CHALLENGE TO THE RELATIONSHIP OF GOD AND HIS CREATION?..........................................................................................198 IS DEONTOLOGY AN APPROPRIATE METHODOLOGICAL PARADIGM FOR EVALUATING SYNTHETIC BIOLOGY ETHICS?...................................207 Limitations on Knowledge in Science …………………………………...209 CONCLUSION……………………………………………………………………..214 CHAPTER 7: THE PLACE OF GOD IN SYNTHETIC BIOLOGY: HOW WILL THE CATHOLIC CHURCH RESPOND? .....................216 BACKGROUND: THE CHURCH, THE MAGISTERIUM AND SCIENCE….….217 Introduction ………………………………………………………………...217 Why Analyse the Catholic Viewpoint? .........................................................222 Some Background: the Catholic Magisterium …………………………….222 Non-overlapping Magisteria? The Magisterium and Science …………….225 THE CHURCH, BIOTECHNOLOGY AND SYNTHETIC BIOLOGY…………..229 The Church and Biotechnology ……………………………………………229 Playing God? The Church and Synthetic Biology ………………………...232 (i) Can synthetic biology be right in itself?........................................233 (ii) Synthetic biology and human enhancement…………………….237 (iii) Synthetic biology and other species……………………………239 (iv) The element of risk in synbio…………………………………..240 (v) Intellectual property and synbio………………………………...243 CONCLUSION……………………………………………………………………..243 CHAPTER 8: INTEGRATING ETHICS “INTO THE DNA” OF SYNTHETIC BIOLOGY …………………………………………………….247 INTRODUCTION…………………………………………………………………..248 HOW ADEQUATE IS THE CURRENT METHODOLOGY?.................................249 SYNBIO’S KNOWLEDGE STRUCTURE OFFERS A ‘MAP’ FOR EVALUATING SYNTHETIC BIOLOGY ETHICS IN DEPTH…………………………….251 HOW SHOULD ETHICISTS (AND SYNTHETIC BIOLOGISTS) BEST RESPOND?....................................................................................................256 CONCLUSION……………………………………………………………………..262 CHAPTER 9: GLOBAL HEALTH JUSTICE AND GOVERNANCE FOR SYNTHETIC BIOLOGY ……………………………………….…….263 4 PART III – CONCLUDING SECTION CHAPTER 10: CONCLUSION …………………………………………….269 INTRODUCTION…………………………………………………………………..269 IS SYNTHETIC BIOLOGY ETHICAL?..................................................................270 REGULATION……………………………………………………………………..272 SYNBIO ETHICS; AND THE LIMITATIONS OF BIOETHICS…………………277 HOW DEEPLY SHOULD THE ETHICAL ANALYSIS ENGAGE WITH THE SCIENCE?.....................................................................................................283 A FURTHER LIMITATION ON BIOETHICAL ANALYSIS: THE TWO CULTURES………………………………………………………………...284 CONCLUSION……………………………………………………………………..287 BIBLIOGRAPHY …………………………………………………………...…289 APPENDIX: PUBLISHED PAPERS ……………………………………...355 Word count, including footnotes: 79,431 5 ABSTRACT University of Manchester PhD in Bioethics and Medical Jurisprudence Patrick Heavey. December 31 st 2012. Ethical Issues in Synthetic Biology Synthetic biology has been defined as: “the design and construction of new biological parts, devices, and systems, and the re-design of existing, natural biological systems for useful purposes” (syntheticbiology.org). The convergence of scientific fields such as molecular biology, computer science and others have rendered it a natural progression, based on existing knowledge. The fact that humanity has reached a stage of development where it seems feasible to “create” life, or design it to a high degree of specificity, is a significant milestone in its history. It generates important ethical questions: Is synthetic biology something good, a natural use of humanity’s talents, or is it a step towards megalomania, playing God, a usurpation of his role? Is it really a natural progression, nature advancing to a state where its products can, in turn, improve nature itself; or does it challenge the dignity of nature by virtue of its “unnaturalness”? Is it an expression of the creative talent of humanity, thus enhancing human dignity, and perhaps that of all life, or does it challenge the dignity of life itself? Regarding its potential consequences, it may, if it succeeds, lead humanity to a new level of development, a paradigm shift comparable with the scientific or industrial revolutions, through a vast increase in scientific knowledge, and subsequent technological developments in all relevant areas, including medicine, food production and fuel development. However, there is potential for serious accidents if synthetic organisms interact with naturally occurring ones, possibly affecting the future course of evolution. Synthetic biology also offers the possibility of creating ever more powerful weapons, more easily than ever before; the technology is reaching a stage where any interested members of the public may be able to create weapons of mass destruction. Synbio is a dual use technology, offering potential for both good and evil. Its potential for either appears to be greater than any other technology that has existed. In this thesis I evaluate the ethics of synthetic biology from the following ethical perspectives – deontology, consequentialism and theology. I am approaching it from several viewpoints so as to give as wide an analysis of the issues as possible. I also evaluate the effectiveness of these standard ethical tools for evaluating synbio ethics. In addition, I examine whether ethics should be more deeply integrated into the day-to-day scientific research in synbio. As a secondary study, I discuss regulation, the main legal issue that synthetic biology generates. 6 DECLARATION No portion of the work in this thesis has been submitted in support of an application for another degree or qualification of this or any other university or other institute of
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