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E-raamat: Ethics for Bioengineering Scientists: Treating Data as Clients

  • Formaat: 342 pages
  • Ilmumisaeg: 08-Dec-2021
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9781000488111
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Ethics for Bioengineering Scientists: Treating Data as ClientsSuurem pilt
  • Formaat: 342 pages
  • Ilmumisaeg: 08-Dec-2021
  • Kirjastus: CRC Press
  • Keel: eng
  • ISBN-13: 9781000488111
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This book introduces bioengineers and students who must generate and/or report scientific data to the ethical challenges they will face in preserving the integrity of their data. It provides the perspective of reaching ethical decisions via pathways that treat data as clients, to whom bioengineering scientists owe a responsibility that is an existential component of their professional identity. The initial chapters lay a historical, biological and philosophical foundation for ethics as a human activity, and data as a foundation of science. The middle chapters explore ethical challenges in lay, engineering, medical and bioengineering scientist settings. These chapters focus on micro-ethics, individual behavior, and cases that showcase the consequences of violating data integrity. Macro-ethics, policy, is dealt with in the Enrichment sections at the end of the chapters, with essay problems and subjects for debates (in a classroom setting). The book can be used for individual study, using links in the Enrichment sections to access cases and media presentations, like PBS "Ethics in America". The final chapters explore the impact of bioengineering science ethics on patients, via medical product development, its regulation by the FDA, and the contribution of data integrity violation to product failure. The book was developed for advanced undergraduate and graduate students in bioengineering. It also contains much needed material that researchers and academics would find valuable (e.g., FDA survey, and lab animal research justification).











Introduces an approach to ethical decision making based on treating data as clients







Compares the ethics of three professions; engineering, medicine and bioengineering







Provides five moral theories to choose from for evaluating ethical decisions, and includes a procedure for applying them to moral analysis, and application of the procedure to example cases.







Examines core concepts, like autonomy, confidentiality, conflict of interest and justice







Explains the process of developing a medical product under FDA regulation







Explores the role of lawyers and the judiciary in product development, including intellectual property protection







Examines a range of ethical cases, from the historical Tuskegee autonomy case to the modern CRISPR-Cas9 patent case.

Howard Winet, PhD is an Adjunct Professor recall, Orthopaedic Surgery and Bioengineering at University of California, Los Angeles.
Preface xiii
Acknowledgments xvii
Introduction xix
Author Biography xxi
Acronyms xxiii
Chapter 1 Bioengineering and Ethics 1(32)
1.1 Bioengineering as an Interdisciplinary Profession
1(1)
1.2 What BEs May Do
1(1)
1.3 Basis for Value Conflict between Bio and Engineering
2(1)
1.4 The Ancient Period and First Western Societies
2(2)
1.5 The Classical Period-Mythos and Logos
4(4)
1.6 Decline of the Latin World and Rise of the Islamic World
8(2)
1.7 The 12th-century Rise of the Universities (800-1400)
10(2)
1.8 The Italian Renaissance (1400-1650)
12(5)
1.9 Emergence of Science from Philosophy-The Enlightenment (1650-1750)
17(1)
1.10 The Industrial Revolution-Determinism and Reductionism
18(2)
1.11 The Industrial Revolution-Causalism and Empiricism in Science
20(3)
1.12 The Second Industrial Revolution-Darwin Changes Human Concept of Self in the 19th Century
23(5)
1.13 The Path to Bioengineering from 1927
28(2)
1.14 The Advent of Bioengineering
30(1)
1.15 Bioengineering and Epidemiology
31(2)
Chapter 2 Ethics Biology: Are There Ethical Genomes? 33(12)
2.1 Some Definitions
33(1)
2.2 The Unethical Experiment
33(1)
2.3 Can We Infer a Genetic Basis for Altruistic Behavior from Psychology?
34(1)
2.4 A Partial Substitute for the Human Experiment: Evolutionary Psychology
35(3)
2.5 Ethical/Moral Behavior in Non-Human Primates (from de Waal 1997)
38(1)
2.6 The Key to Ethical Motivation Is That Which Is Valued
39(1)
2.7 The Biological Structure of Moral/Ethical Behavior
40(2)
2.8 Classical Case Supporting a Biological Basis for Morality/Ethical Behavior
42(1)
2.9 Evolutionary Psychology and Social Darwinism
43(2)
Chapter 3 Philosophical Basis for Moral Analysis 45(22)
3.1 The Eugenics Movement, a General Case Study Illustrating the Need for Ethical Analysis
45(1)
3.2 Macroethics vs. Microethics (Herkert 2005)
46(1)
3.3 The Concept of Moral Theory
46(1)
3.4 Motivation for Applying Moral Theories
47(1)
3.5 Overview of Moral Theories Used in This Book
48(1)
3.6 Consequentialism-General and Specific-type Utilitarianism
48(4)
3.7 Nonconsequentialism-Deontology
52(1)
3.8 Kantian Deontology
53(2)
3.9 Rossian Deontology
55(1)
3.10 Contractarianism
56(2)
3.11 Virtue Ethics
58(2)
3.12 Feminist Ethics-The Ethics of Care
60(3)
3.13 Critiques of the Five Moral Theories
63(4)
Chapter 4 Moral Analysis: Deriving a Moral Decision 67(16)
4.1 Recognizing that an Ethical Problem Exists
67(1)
4.2 Kinds of Moral Challenges
68(1)
4.3 Commitment to Implementing a Solution
69(1)
4.4 Basic Strategy for Moral/ethical Analysis
69(1)
4.5 Example Case (Adapted From Rowan and Zinaich 2003)
70(5)
4.6 Actual Case Example, John Moore v. Regents, University of California et al. (Supreme Court of California No. S006987)
75(5)
4.7 A Word about Applications of Moral Analysis in this
Chapter
80(1)
4.8 How Will You Apply a Moral Analysis?
81(2)
Chapter 5 Separating Professional from Lay Ethics 83(20)
5.1 Ethics and Professional Responsibility
83(1)
5.2 Lay Ethics of Employee-Employee and Supervisor-Employee Interactions
84(2)
5.3 Professionals as Employees and Supervisors
86(1)
5.4 Professionals and Clients
87(1)
5.5 Individual Goals that Should Be Accomplished (Adapted from Faber 2003)
88(1)
5.6 Level/Form of Participation in Decision-Making and Implementation (Adapted from Faber 2003)
89(5)
5.7 Prima Facie Obligations of All Professionals: Confidentiality, Client Autonomy
94(3)
5.8 When Obligations Conflict: Conflict of Interest
97(1)
5.9 Coworkers and Clients
97(6)
Chapter 6 Engineering Ethics 103(14)
6.1 The Engineer's Client
104(1)
6.2 The Classic Engineering Ethics Case-Monetary Value of a Human Life
105(4)
6.3 Engineering Codes of Ethics
109(1)
6.4 The BART Case-Unprotected Whistleblowing by Engineers
110(2)
6.5 The Challenger Case-Failure to Blow the Whistle
112(1)
6.6 Basic Engineering Business Ethics
113(1)
6.7 Cultural Variation in Business Ethics
113(1)
6.8 Intellectual Property
114(1)
6.9 The Key Lessons
114(3)
Chapter 7 Medical Ethics 117(20)
7.1 The Physician's Client
118(1)
7.2 The Standard of Care
118(1)
7.3 Autonomy as It Relates to the Health Professions
119(1)
7.4 Example of Autonomy in Action
119(1)
7.5 The Components of Autonomy
120(1)
7.6 Two Interpretations of Autonomy
121(1)
7.7 Deciding If the Patient Has True Autonomy
122(2)
7.8 Physician Role in Autonomy
124(1)
7.9 Physician Role in Confidentiality
125(1)
7.10 Physician Guidelines When Patient Information Must Be Shared
126(1)
7.11 Physician's Code of Ethics
126(1)
7.12 Conflict of Interest in the Health Profession
127(2)
7.13 The Impact of Science on the Physician-Patient Relationship
129(1)
7.14 The Hospital IRB as the Patient's Local Watchdog
130(1)
7.15 The Advanced Health-care Directive
130(1)
7.16 Ethical Issues Associated with Treatment
131(1)
7.17 The Physician, a Life of Diagnosis and Treatment
132(5)
Chapter 8 Bioengineering Scientist Ethics 137(20)
8.1 Bioengineers as Scientists
137(1)
8.2 Bioengineering Scientists Cannot Be Truth Professionals
137(2)
8.3 The Scientific Investigation
139(2)
8.4 Data, the Scientists' Clients
141(1)
8.5 Science Profession Code of Ethics
141(1)
8.6 Funding and Government Regulation of Scientific Ethics
142(1)
8.7 Scientific Misconduct
143(1)
8.8 Government Decreed Scientific Ethics
144(1)
8.9 Evidentiary Requirements for Findings of Research Misconduct
144(1)
8.10 Populations Where Scientific Misconduct Occurs
145(7)
8.11 Scientific Misconduct Cases
152(3)
8.12 The Bioengineering Scientist as a Professional
155(2)
Chapter 9 Ethics of Research with Non-Human Animals 157(12)
9.1 History of Animal Use by Humans
157(1)
9.2 Changes in Human Link with Domestic Animals
158(1)
9.3 The Animal Rights Movement
159(3)
9.4 The Scientific Basis for Humane Treatment of Laboratory Animals
162(1)
9.5 Development of Animal Research Regulations
162(7)
Chapter 10 Health Professionals and Historic Human Research Ethics 169(12)
10.1 The Tradition of Experimenting on Humans
169(1)
10.2 The Tuskegee Syphilis Study
170(2)
10.3 Nazi Use of Human Experimental Subjects
172(2)
10.4 Japanese Army Experiments Using Chinese Civilians in Ping Fan
174(1)
10.5 Development of First Conventions Regulating Experiments Using Human Subjects
175(1)
10.6 The Nuremberg Code
176(2)
10.7 The Helsinki Declaration and OPRR
178(1)
10.8 The National Research Act and the Belmont Report
178(1)
10.9 Humans Being Humans
179(2)
Chapter 11 Health Professionals and Modern Human Research Ethics 181(18)
11.1 The Industrial Revolution Creates a Drug Industry
181(1)
11.2 Science, Medicine, and Technology Come Together after 1945
182(1)
11.3 Medical Research in University and Pharmaceutical Laboratories
183(1)
11.4 Science and Technology Create Biomedical Physicians
184(1)
11.5 What Is Pre-clinical Research?
185(1)
11.6 What Is Clinical Research?
185(2)
11.7 Case Study: Hyman v. Jewish Chronic Disease Hospital (JCDH) of New York and Informed Consent-Vulnerable Patients
187(1)
11.8 Clinical Research and the Practice of Medicine
188(1)
11.9 Impact of the "Heyday of Drug Development" on Medical Practice
189(2)
11.10 Case Study: Possible Conflict of Interest in Research Using Human Subjects
191(1)
11.11 Non-medical Scientific Research Using Human Subjects
191(1)
11.12 Naming the Third Pharmaceutical Epoch
192(1)
11.13 Physicians in Practice and the FDA in the Third Pharmaceutical Epoch
193(1)
11.14 Imaginary Case Study: Financial Conflict of Interest
194(1)
11.15 Financial Conflict of Interest and the Grassley-Kohl Sunshine Act
195(1)
11.16 Human Subject Disregard for Science (Based on an Account from Murphy 2004)
196(1)
11.17 The FDA as a Regulator of Research with Human Subjects
197(2)
Chapter 12 Ethics of Medical Product Development 199(20)
12.1 The Bioengineer as a Product Developer
199(1)
12.2 Bioengineer, Engineer and Physician: The Medical Product Development Team
199(1)
12.3 The Public and the Government Place Limits on Medical Products
200(1)
12.4 A History of the FDA
201(3)
12.5 FDA Device Classification
204(4)
12.6 Preclinical Testing
208(1)
12.7 Publishing Pre-clinical Test Results
209(2)
12.8 Considerations that Enhance Success of Clinical Trials
211(1)
12.9 Clinical Trials
212(2)
12.10 Protecting a Device or Drug as Intellectual Property
214(2)
12.11 CRISPR Patent Case: Regents, University of California v. Broad Institute, Inc.
216(1)
12.12 The Brave New World of Genomic Technology Clinical Research
217(2)
Chapter 13 Ethics of Product Failure and the Courts 219(18)
13.1 Phase III Monitoring of an FDA-approved Device Has No End Date
220(1)
13.2 Enter the Lawyers
220(2)
13.3 How Does a Device Failure Become a Court Case?
222(1)
13.4 Intrauterine Device (IUD) The Dalkon Shield Case (1971) (after Mayesh and Scranton 2004)
223(2)
13.5 The Artificial Heart Valve Cases (after Mayesh and Scranton 2004)
225(1)
13.6 Metal-on-Metal ASR Case (after Cohen 2011)
226(3)
13.7 Silicone Breast Implant Cases (after Schleiter 2010, and Hooper 2001)
229(3)
13.8 Expert Witnessing and the Federal Rules of Evidence: Daubert v. Merrill Dow Pharmaceuticals (after SKAPP 2003)
232(1)
13.9 Can the FDA Be Sued?
233(1)
13.10 The Future of Data Care
234(3)
References 237(8)
Glossary 245(24)
Appendix A Suggested Format for Class Debates 269(2)
Appendix B Informed Consent 271(6)
Appendix C Advance Health Care Directive Example 277(8)
Appendix D Research Misconduct Policy Example 285(12)
Appendix E Significant Events in the History of Experimentation With Human Subjects 297(8)
Appendix F Examples for Safe Medical Devices Act Report Incidents 305(6)
Index 311
Howard Winet PhD is an Adjunct Professor, Orthopaedic Surgery and Bioengineering at University of California, Los Angeles.
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