Biomedical Ethics for Engineers: Ethics and Decision Making in Biomedical and Biosystem Engineering

Daniel A. Vallero, Ph.D.

AMSTERDAM • BOSTON • HEIDELBERG • LONDON • NEW YORK • OXFORD PARIS • SAN DIEGO • SAN FRANCISCO • SINGAPORE • SYDNEY • TOKYO

ELSEVIER Academic Press is an imprint of Elsevier

Contents

Preface xi Done Is Good xiv Structure and Pedagogy xvi Notes and Commentary xix

Acknowledgments xxi Bioethics Questions Posed in Text xxiii

Prologue: Bioethics - Discovery through Design A Different Approach to Bioethics 3 Arguments for and Against Case Analysis 4 Driver's Education Analogy 5 Example Case: Priming the Pump 6 Case Analysis 7 Notes and Commentary 8

Chapter 1

Bioethics: A Creative Approach Thought Experiments 10 Teachable Moment: Trust 12 The Principle of Double Effect 12 Teachable Moment: The Engineer as Agent versus Judge 12 Amy the Engineer 15 Teachable Moment: Who Was Van Rensselaer Potter? 18 Credat Emptor 18 Teachable Moment: Capital Punishment, Abortion, and the Definition of Human Life 20 The Good Engineer 21 Feedback and Enhancement of Design 22 Teachable Moment: The Good Engineer 24 The Profession of Engineering 25 Engineering Bioethics and Morality 26 Discussion Box: Ethics and the Butterfly Effect 27 "Small" Error and Devastating Outcomes 28 Technology, Engineering, and Economics 28 Teachable Moment: The Dismal Scientist versus the Technological Optimist 31 Engineering Competence 39

VI

Engineering: Both Integrated and Specialized 39 Who Is a Professional? 40 What Is Technical? 41 Systematics: Incorporating Ethics into the Design Process 42 Notes and Commentary 43

Chapter 2

Bioethics and the Engineer Major Bioethical Areas 51 Cloning and Stem Cell Research 52 Teachable Moment: Nanog 56 Human Enhancement 57 Patenting Life 57 Teachable Moment: Patenting Germplasm 58 Neuroethics 59 Organ Transplantation 60 Responsible Conduct of Human Research 60 Animal Testing 61

Is the Research Worth It? 63 Systematic Reality Check 66

Genetically Modified Organisms 67 Transgenic Species 68 Food 68

Environmental Health: The Ethics of Scale and the Scale of Ethics Temporal Aspects of Bioethical Decisions: Environmental Case Studies

Agent Orange 71 Japanese Metal Industries 74

Minamata Mercury Case 74 Cadmium and Itai Itai Disease 75

Scale Is More than Size 77 Love Canal 78 Times Beach 79

Teachable Moment: The Whole Is Greater than the Sum of Its Parts 80 Active Engineering 81 Ethical Theories: A Primer 83

Truth 84 Psychological Aspects of Ethics 86

Teachable Moment: The Physiome Project: The Macroethics of Engineering toward Health 89

Fairness 94 Value as a Bioethical and Engineering Concept 95 Technical Optimism versus Dismal Science 96

Notes and Commentary 98

Contents VII

Chapter 3

An Engineered Future: Human Enhancement Professional Zeitgeist: How Engineers Think 106 Improvement versus Enhancement 109 Engineering Intuition 111 Engineers versus Economists 112 Intuiting Value 113 Deductive and Inductive Reasoning: Precursors to Intuition 114 Creativity 116 Moral Coherence 120 Creativity and Bioethics 122 The Ethical Quandary of Enhancement 124 Scientific Dissent 126 Notes and Commentary 134

Chapter 4

The Bioethical Engineer Professional Trust 139 Codes of Ethics: Words to Live By 142 Discussion Box: The Code of Hammurabi 143 Limitations of Codes of Ethics 147 Risk Shifting: Organochlorine Pesticides 147 Right of Professional Conscience 152 Groupthink and the Right of Conscience 156 Animals and Engineers 158 Teachable Moment: Confined Animal Feeding Operations and the Moral

Standing of Animals 159 Making Ethical Decisions in Engineering 160 Discussion Box: Four Persons Who Changed the Way We Think about Nature 162 John Muir 162 Rachel Carson 162 Christopher Stone 163 Gaylord Nelson 164 Notes and Commentary 164

Chapter 5

Bioethical Research and Technological Development Beyond Regulation 169 Integrity 169 Teachable Moment: The Therapeutic Misconception 173

V l l l

The Experiment 173 The Hypothetico-Deductive Method 174 Research Conflict of Interest 175 Teachable Moment: Truth and Turtles 176 Professionalism 178 Technology: Friend and Foe 178 Teachable Moment: Medical Device Risk 179

Risk Homeostasis and the Theory of Offsetting Behavior 180 Artifacts 182 Automation and Mechanization of Medicine 183 Professional Consideration: Do Engineers Have Patients? 184

Technological Reliability 185 Low Tech Engineering 189 Information Technology 190 The Ethics of Nanotechnology 193 Notes and Commentary 195

Chapter 6

Bioethical Success and Failure Teachable Moment: Engineering Measurement 201 Measurements of Success and Failure 203 Technological Success and Failure 203 Risk as a Bioethical Concept 205 Safety, Risk, and Reliability in Design 206 Probability: The Mathematics of Risk and Reliability 206 Discussion Box: Choose Your Risk 210 Reliability: An Ethics Metrie 214 Reducing Risks 217 Risk as an Ethical Concept 220 Risk-Based Ethics: The Syllogism Revisited 223 Causation 225 Biographical Box: Sir Bradford Hill 226 Notes and Commentary 228

Chapter 7

Analyzing Bioethical Success and Failure Medical Device Failure: Human Factors Engineering 232 Teachable Moment: How to Analyse a Medical Device 233 Utility as a Measure of Success 234

Failure Type 1: Mistakes and Miscalculations 236 Failure Type 2: Extraordinary Natural Circumstances 236 Failure Type 3: Critical Path 237

Contents

Failure Type 4: Negligence 243 Failure Type 5: Lack of Imagination 244

Bioterrorism: The Engineer's Response 244 Dual Use and Primacy of Science 246 Social Response of Engineering to Terrorism 248

Success Paradigms 248 Characterizing Success and Failure 249 Accountability 249 Value 250 Case Analysis 250 Notes and Commentary 258

Chapter 8

Justice and Fairness as Biomedical and Biosystem Engineering Concepts

Fairness and Distributive Justice 263 Discussion Box: Harm and the Hippocratic Oath 271 Teachable Moment: Disposal of a Slightly Hazardous Waste 272 Solution and Discussion 272 Though Experiment: Who Is More Ethical? 274 Professional Virtue and Empathy 277 Teachable Moment: Albert Schweitzer and the Reverence

for Life 277 Reason 279 Teachable Moment: Abortion, Fairness, and Justice 280 Utility 281 Teachable Moment: Utility and Futility 283 Precaution as a Bioethical Concept 285 Discussion Box: The Tragedy of the Commons 286 Notes and Commentary 287

Chapter 9

Sustainable Bioethics Green Is Good 291 Sustainability 292 Teachable Moment: Rational Ethics and Thermodynamics 293 Life Cycles and Concurrent Engineering 300 Case Study Box: SIDS, A Concurrent Engineering Failure 301 Discussion Box: The Coffee Cup Debate 305 The Bioethics of Combustion 307

X Contents

Systematic Bioethics 317 Seveso Plant Disaster 318 Poverty and Pollution 320

Interdependence 322 Notes and Commentary 323

Chapter 10

Engineering Wisdom Ethics and Chaos 329 Macroethics and Microethics 330 Future Directions 331 The Humble Engineer 338 Notes and Commentary 340

Epilogue: Practical Bioethics Shutting Down the Pump 343 Objectivity and Finding Truth 344

Moral Courage 346 Bioethics Resources for the Engineer 347 Suggested Readings 348

Ethics of Emerging Technologies 348 Ethical Analysis, Reasoning, and Decision Making 349 Macroethics and Societal Risk 349 Teaching Engineering Macroethics 351 Teaching Engineering Microethics 353

Useful Websites 354 Notes and Commentary 356

Appendix 1 357

Appendix 2 363

Glossary of Terms Likely to Be Encountered in Bioethical Decision Making 365 Name Index 395 Subject Index 397