Ethics for Bioengineering Scientists: Treating Data as Clients

Cover
Half Title
Title Page
Copyright Page
Dedication
Contents
Preface
Acknowledgments
Introduction
Author Biography
Acronyms
1. Bioengineering and Ethics
	1.1 Bioengineering as an Interdisciplinary Profession
	1.2 What BEs MAY DO
	1.3 Basis for Value Conflict Between Bio and Engineering
	1.4 The Ancient Period and First Western Societies
		1.4.1  General
		1.4.2  Medicine
		1.4.3  Engineering
		1.4.4  Science
	1.5 The Classical Period—Mythos and Logos
		1.5.1  General
		1.5.2  Medicine
		1.5.3  Engineering
		1.5.4  Science
	1.6 Decline of the Latin World and Rise of the Islamic World
		1.6.1  Medicine
		1.6.2  Engineering
		1.6.3  Science
	1.7 The 12th Century Rise of the Universities (800-1400)
		1.7.1  General
		1.7.2  Medicine
		1.7.3  Engineering
		1.7.4  Science
	1.8 The Italian Renaissance (1400-1650)
		1.8.1  General
		1.8.2  Medicine
		1.8.3  Engineering
		1.8.4  Science
	1.9 Emergence of Science from Philosophy—The Enlightenment (1650-1750)
		1.9.1  General
		1.9.2  Medicine
		1.9.3  Engineering
		1.9.4  Science
	1.10 The Industrial Revolution—Determinism and Reductionism
		1.10.1  General
		1.10.2  Medicine
		1.10.3  Engineering
		1.10.4  Science
	1.11 The Industrial Revolution—Causalism and Empiricism in Science
		1.11.1  Causalism and the Three Professions
			1.11.1.1 Causalism vs. Empiricism in Ethical Decisions—The Ebola Case Example (from WHO Website ()
		1.11.2  Statistics and Science
	1.12 The Second Industrial Revolution—Darwin Changes Human Concept of Self In the 19th Century
		1.12.1  General
		1.12.2  Medicine
		1.12.3  Engineering
		1.12.4  Science
	1.13 The Path to Bioengineering from 1927
	1.14 The Advent of Bioengineering
	1.15 Bioengineering and Epidemiology
2. Ethics Biology: Are There Ethical Genomes?
	2.1 Some Definitions
	2.2 The Unethical Experiment
	2.3 Can We Infer a Genetic Basis for Altruistic Behavior from Psychology?
	2.4 A Partial Substitute for the Human Experiment: Evolutionary Psychology
	2.5 Ethical/Moral Behavior in Nonhuman Primates (from de Waal 1997)
	2.6 The Key to Ethical Motivation Is That which Is Valued
	2.7 The Biological Structure of Moral/Ethical Behavior
	2.8 Classical Case Supporting a Biological Basis for Morality/Ethical Behavior
	2.9 Evolutionary Psychology and Social Darwinism
3. Philosophical Basis for Moral Analysis
	3.1 The Eugenics Movement, a General Case Study Illustrating the Need for Ethical Analysis
	3.2 Macroethics vs. Microethics (Herkert 2005)
	3.3 The Concept of Moral Theory
	3.4 Motivation for Applying Moral Theories
	3.5 Overview of Moral Theories Used in This Book
	3.6 Consequentialism—General and Specific-Type Utilitarianism
	3.7 Nonconsequentialism—Deontology
	3.8 Kantian Deontology
	3.9 Rossian Deontology
	3.10 Contractarianism
	3.11 Virtue Ethics
	3.12 Feminist Ethics—The Ethics of Care
	3.13 Critiques of the Five Moral Theories
4. Moral Analysis: Deriving a Moral Decision
	4.1 Recognizing That an Ethical Problem Exists
	4.2 Kinds of Moral Challenges
	4.3 Commitment to Implementing a Solution
	4.4 Basic Strategy for Moral/Ethical Analysis
	4.5 Example Case (Adapted from Rowan and Zinaich )
	4.6 Actual Case Example, John Moore v. Regents, University of California et al. (Supreme Court of California No. S006987)
	4.7 A Word about Applications of Moral Analysis in this Chapter
	4.8 How Will You Apply a Moral Analysis?
5. Separating Professional from Lay Ethics
	5.1 Ethics and Professional Responsibility
	5.2 Lay Ethics of Employee-Employee and Supervisor-Employee Interactions
	5.3 Professionals as Employees and Supervisors
	5.4 Professionals and Clients
	5.5 Individual Goals that Should Be Accomplished (Adapted from Faber )
	5.6 Level/Form of Participation in Decision-Making and Implementation (Adapted from Faber )
		5.6.1 The Agency Form
		5.6.2 The Paternalism Form
		5.6.3 The Contractual Form
		5.6.4 The Affinity Form
		5.6.5 The Professional Fiduciary Form
	5.7 Prima Facie Obligations of All Professionals: Confidentiality, Client Autonomy
		5.7.1 Client Autonomy
		5.7.2 Confidentiality (Adapted from Armstrong )
	5.8 When Obligations Conflict: Conflict of Interest
	5.9 Coworkers and Clients
6. Engineering Ethics
	6.1 The Engineer\'s Client
	6.2 The Classic Engineering Ethics Case—Monetary Value of a Human Life
	6.3 Engineering Codes of Ethics
	6.4 The BART Case—Unprotected Whistleblowing by Engineers
	6.5 The Challenger Case—Failure to Blow the Whistle
	6.6 Basic Engineering Business Ethics
	6.7 Cultural Variation in Business Ethics
	6.8 Intellectual Property
	6.9 The Key Lessons
7. Medical Ethics
	7.1 The Physician\'s Client
	7.2 The Standard of Care
	7.3 Autonomy as it Relates to the Health Professions
	7.4 Example of Autonomy in Action
	7.5 The Components of Autonomy
	7.6 Two Interpretations of Autonomy
	7.7 Deciding If the Patient Has True Autonomy
	7.8 Physician Role in Autonomy
	7.9 Physician Role in Confidentiality
	7.10 Physician Guidelines When Patient Information Must Be Shared
	7.11 Physician\'s Code of Ethics
	7.12 Conflict of Interest in the Health Profession
	7.13 The Impact of Science on the Physician-Patient Relationship
	7.14 The Hospital IRB as the Patient\'s Local Watchdog
	7.15 The Advanced Health-care Directive
	7.16 Ethical Issues Associated with Treatment
	7.17 The Physician, a Life of Diagnosis and Treatment
8. Bioengineering Scientist Ethics
	8.1 Bioengineers as Scientists
	8.2 Bioengineering Scientists Cannot Be Truth Professionals
	8.3 The Scientific Investigation
	8.4 Data, the Scientists\' Clients
	8.5 Science Profession Code of Ethics
	8.6 Funding and Government Regulation of Scientific Ethics
	8.7 Scientific Misconduct
	8.8 Government Decreed Scientific Ethics
	8.9 Evidentiary Requirements for Findings of Research Misconduct
	8.10 Populations Where Scientific Misconduct Occurs
		8.10.1 Researchers
		8.10.2 Authors
		8.10.3 Processors of Submitted Work
			8.10.3.1 Advanced Degree Committees
			8.10.3.2 Journal/Abstract Reviewers
			8.10.3.3 Application Reviewers
			8.10.3.4 Supervisory Reviewers
			8.10.3.5 Honor Agency Reviewers
			8.10.3.6 Predatory Publishers
	8.11 Scientific Misconduct Cases
		8.11.1 The Classic Scientific Ethics Course Case: The Piltdown Man
		8.11.2 Scientific Misconduct in Cloning, Woo-suk Hwang Case (see https://embryo.asu.edu/pages/hwang-woo-suks-use-human-eggs-research-2002-2005)
		8.11.3 Data Malfeasance: The John Darsee Case (see https://www.nytimes.com/1983/06/14/science/notorious-darsee-case-shakes-assumptions-about-science.html)
		8.11.4 Data Fabrication. The William Summerlin Case
		8.11.5 Threatening Human Life. The Andrew Wakefield Case (Adapted from  and Gross )
	8.12 The Bioengineering Scientist as a Professional
9. Ethics of Research with Non-Human Animals
	9.1 History of Animal Use by Humans
	9.2 Changes in Human Link with Domestic Animals
	9.3 The Animal Rights Movement
	9.4 The Scientific Basis for Humane Treatment of Laboratory Animals
	9.5 Development of Animal Research Regulations
10. Health Professionals and Historic Human Research Ethics
	10.1 The Tradition of Experimenting on Humans
	10.2 The Tuskegee Syphilis Study
	10.3 Nazi Use of Human Experimental Subjects
	10.4 Japanese Army Experiments using Chinese Civilians in Ping Fan
	10.5 Development of First Conventions Regulating Experiments using Human Subjects
	10.6 The Nuremberg Code
	10.7 The Helsinki Declaration and OPRR
	10.8 The National Research Act and the Belmont Report
	10.9 Humans Being Humans
11. Health Professionals and Modern Human Research Ethics
	11.1 The Industrial Revolution Creates a Drug Industry
	11.2 Science, Medicine, and Technology Come Together after 1945
	11.3 Medical Research in University and Pharmaceutical Laboratories
	11.4 Science and Technology Create Biomedical Physicians
	11.5 What Is Pre-Clinical Research?
	11.6 What Is Clinical Research?
	11.7 Case Study: Hyman v. Jewish Chronic Disease Hospital (JCDH) of New York and Informed Consent—Vulnerable Patients
	11.8 Clinical Research and the Practice of Medicine
	11.9 Impact of the \"Heyday of Drug Development\" on Medical Practice
	11.10 Case Study: Possible Conflict of Interest in Research using Human Subjects
	11.11 Non-Medical Scientific Research using Human Subjects
	11.12 Naming the Third Pharmaceutical Epoch
	11.13 Physicians in Practice and the FDA in the Third Pharmaceutical Epoch
	11.14 Imaginary Case Study: Financial Conflict of Interest
	11.15 Financial Conflict of Interest and the Grassley-Kohl Sunshine Act
	11.16 Human Subject Disregard for Science (Based on an Account from )
	11.17 The FDA as a Regulator of Research with Human Subjects
12. Ethics of Medical Product Development
	12.1 The Bioengineer as a Product Developer
	12.2 Bioengineer, Engineer and Physician: The Medical Product Development Team
	12.3 The Public and the Government Place Limits on Medical Products
	12.4 A History of the FDA
	12.5 FDA device classification (refer to https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ for a complete summary of device classification criteria)
	12.6 Preclinical Testing
	12.7 Publishing Pre-Clinical Test Results
	12.8 Considerations That Enhance Success of Clinical Trials
	12.9 Clinical Trials
		12.9.1 Phase I
		12.9.2 Phase II
		12.9.3 Phase III
	12.10 Protecting a Device or Drug as Intellectual Property
	12.11 CRISPR Patent Case: Regents, University of California v. Broad Institute, Inc.
	12.12 The Brave New World of Genomic Technology Clinical Research
13. Ethics of Product Failure and the Courts
	13.1 Phase III Monitoring of an FDA-approved Device Has No End Date
	13.2 Enter the Lawyers
	13.3 How Does a Device Failure Become a Court Case?
	13.4 Intrauterine Device (IUD) The Dalkon Shield Case (1971) (after Mayesh and Scranton 2004)
	13.5 The Artificial Heart Valve Cases (after Mayesh and Scranton 2004)
	13.6 Metal-on-Metal ASR Case (after Cohen 2011)
	13.7 Silicone Breast Implant Cases (after Schleiter 2010 and Hooper 2001)
	13.8 Expert Witnessing and the Federal Rules of Evidence: Daubert v. Merrill Dow Pharmaceuticals (after SKAPP 2003)
	13.9 Can the FDA Be Sued?
	13.10 The Future of Data Care
References
Glossary
Appendix A Suggested Format for Class Debates
Appendix B  Informed Consent
	Clinical Research
		Observational Study Consent Form
		Purpose of the Observational Study
		Reasons for the Observational Study
		What Will You Be Doing?
		Benefits and Risks
			Blood Draw
			Bone Density Measurement
			Urine Sample
		Costs
		Confidentiality
		Right to Withdraw
		Voluntary Consent
		Other Information
		Investigator\'s Statement
		Participant Statement
Appendix C  Advance Health Care Directive Example
	Part 1 Power of Attorney for Health Care
	Part 2 Instructions for Health Care
	Part 3 Donation of Organs, Tissues, and Parts at Death (Optional)
	Part 4 Primary Physician (Optional)
	Part 5
	Part 6 Special Witness Requirement
Appendix D  Research Misconduct Policy Example
	I References
	II Definitions
	III General Policy
	IV Procedures
		A Applicability
		B Allegations of Research Misconduct
		C Initial Assessment
		D Securing of Evidence
		E General Standards for Committees and Administrators
		F Conducting an Inquiry
		G Conducting an Investigation
			1 Appointment of Committee
			2 Investigation
			3 Evidentiary Requirements for Findings of Research Misconduct
		H VCR\'s Determination of Research Misconduct
		I VCR\'s Other Notification Responsibilities
	V Attachments
		A Other Related Policies, Procedures, and Resources
Appendix E Significant Events in the History of Experimentation With Human Subjects
Appendix F Examples of Medical Device Report Incidents
Index