دانلود کتاب Ethics for Bioengineering Scientists: Treating Data as Clients

فهرست مطالب :

Cover\nHalf Title\nTitle Page\nCopyright Page\nDedication\nContents\nPreface\nAcknowledgments\nIntroduction\nAuthor Biography\nAcronyms\n1. Bioengineering and Ethics\n 1.1 Bioengineering as an Interdisciplinary Profession\n 1.2 What BEs MAY DO\n 1.3 Basis for Value Conflict Between Bio and Engineering\n 1.4 The Ancient Period and First Western Societies\n 1.4.1 General\n 1.4.2 Medicine\n 1.4.3 Engineering\n 1.4.4 Science\n 1.5 The Classical Period—Mythos and Logos\n 1.5.1 General\n 1.5.2 Medicine\n 1.5.3 Engineering\n 1.5.4 Science\n 1.6 Decline of the Latin World and Rise of the Islamic World\n 1.6.1 Medicine\n 1.6.2 Engineering\n 1.6.3 Science\n 1.7 The 12th Century Rise of the Universities (800-1400)\n 1.7.1 General\n 1.7.2 Medicine\n 1.7.3 Engineering\n 1.7.4 Science\n 1.8 The Italian Renaissance (1400-1650)\n 1.8.1 General\n 1.8.2 Medicine\n 1.8.3 Engineering\n 1.8.4 Science\n 1.9 Emergence of Science from Philosophy—The Enlightenment (1650-1750)\n 1.9.1 General\n 1.9.2 Medicine\n 1.9.3 Engineering\n 1.9.4 Science\n 1.10 The Industrial Revolution—Determinism and Reductionism\n 1.10.1 General\n 1.10.2 Medicine\n 1.10.3 Engineering\n 1.10.4 Science\n 1.11 The Industrial Revolution—Causalism and Empiricism in Science\n 1.11.1 Causalism and the Three Professions\n 1.11.1.1 Causalism vs. Empiricism in Ethical Decisions—The Ebola Case Example (from WHO Website ()\n 1.11.2 Statistics and Science\n 1.12 The Second Industrial Revolution—Darwin Changes Human Concept of Self In the 19th Century\n 1.12.1 General\n 1.12.2 Medicine\n 1.12.3 Engineering\n 1.12.4 Science\n 1.13 The Path to Bioengineering from 1927\n 1.14 The Advent of Bioengineering\n 1.15 Bioengineering and Epidemiology\n2. Ethics Biology: Are There Ethical Genomes?\n 2.1 Some Definitions\n 2.2 The Unethical Experiment\n 2.3 Can We Infer a Genetic Basis for Altruistic Behavior from Psychology?\n 2.4 A Partial Substitute for the Human Experiment: Evolutionary Psychology\n 2.5 Ethical/Moral Behavior in Nonhuman Primates (from de Waal 1997)\n 2.6 The Key to Ethical Motivation Is That which Is Valued\n 2.7 The Biological Structure of Moral/Ethical Behavior\n 2.8 Classical Case Supporting a Biological Basis for Morality/Ethical Behavior\n 2.9 Evolutionary Psychology and Social Darwinism\n3. Philosophical Basis for Moral Analysis\n 3.1 The Eugenics Movement, a General Case Study Illustrating the Need for Ethical Analysis\n 3.2 Macroethics vs. Microethics (Herkert 2005)\n 3.3 The Concept of Moral Theory\n 3.4 Motivation for Applying Moral Theories\n 3.5 Overview of Moral Theories Used in This Book\n 3.6 Consequentialism—General and Specific-Type Utilitarianism\n 3.7 Nonconsequentialism—Deontology\n 3.8 Kantian Deontology\n 3.9 Rossian Deontology\n 3.10 Contractarianism\n 3.11 Virtue Ethics\n 3.12 Feminist Ethics—The Ethics of Care\n 3.13 Critiques of the Five Moral Theories\n4. Moral Analysis: Deriving a Moral Decision\n 4.1 Recognizing That an Ethical Problem Exists\n 4.2 Kinds of Moral Challenges\n 4.3 Commitment to Implementing a Solution\n 4.4 Basic Strategy for Moral/Ethical Analysis\n 4.5 Example Case (Adapted from Rowan and Zinaich )\n 4.6 Actual Case Example, John Moore v. Regents, University of California et al. (Supreme Court of California No. S006987)\n 4.7 A Word about Applications of Moral Analysis in this Chapter\n 4.8 How Will You Apply a Moral Analysis?\n5. Separating Professional from Lay Ethics\n 5.1 Ethics and Professional Responsibility\n 5.2 Lay Ethics of Employee-Employee and Supervisor-Employee Interactions\n 5.3 Professionals as Employees and Supervisors\n 5.4 Professionals and Clients\n 5.5 Individual Goals that Should Be Accomplished (Adapted from Faber )\n 5.6 Level/Form of Participation in Decision-Making and Implementation (Adapted from Faber )\n 5.6.1 The Agency Form\n 5.6.2 The Paternalism Form\n 5.6.3 The Contractual Form\n 5.6.4 The Affinity Form\n 5.6.5 The Professional Fiduciary Form\n 5.7 Prima Facie Obligations of All Professionals: Confidentiality, Client Autonomy\n 5.7.1 Client Autonomy\n 5.7.2 Confidentiality (Adapted from Armstrong )\n 5.8 When Obligations Conflict: Conflict of Interest\n 5.9 Coworkers and Clients\n6. Engineering Ethics\n 6.1 The Engineer\'s Client\n 6.2 The Classic Engineering Ethics Case—Monetary Value of a Human Life\n 6.3 Engineering Codes of Ethics\n 6.4 The BART Case—Unprotected Whistleblowing by Engineers\n 6.5 The Challenger Case—Failure to Blow the Whistle\n 6.6 Basic Engineering Business Ethics\n 6.7 Cultural Variation in Business Ethics\n 6.8 Intellectual Property\n 6.9 The Key Lessons\n7. Medical Ethics\n 7.1 The Physician\'s Client\n 7.2 The Standard of Care\n 7.3 Autonomy as it Relates to the Health Professions\n 7.4 Example of Autonomy in Action\n 7.5 The Components of Autonomy\n 7.6 Two Interpretations of Autonomy\n 7.7 Deciding If the Patient Has True Autonomy\n 7.8 Physician Role in Autonomy\n 7.9 Physician Role in Confidentiality\n 7.10 Physician Guidelines When Patient Information Must Be Shared\n 7.11 Physician\'s Code of Ethics\n 7.12 Conflict of Interest in the Health Profession\n 7.13 The Impact of Science on the Physician-Patient Relationship\n 7.14 The Hospital IRB as the Patient\'s Local Watchdog\n 7.15 The Advanced Health-care Directive\n 7.16 Ethical Issues Associated with Treatment\n 7.17 The Physician, a Life of Diagnosis and Treatment\n8. Bioengineering Scientist Ethics\n 8.1 Bioengineers as Scientists\n 8.2 Bioengineering Scientists Cannot Be Truth Professionals\n 8.3 The Scientific Investigation\n 8.4 Data, the Scientists\' Clients\n 8.5 Science Profession Code of Ethics\n 8.6 Funding and Government Regulation of Scientific Ethics\n 8.7 Scientific Misconduct\n 8.8 Government Decreed Scientific Ethics\n 8.9 Evidentiary Requirements for Findings of Research Misconduct\n 8.10 Populations Where Scientific Misconduct Occurs\n 8.10.1 Researchers\n 8.10.2 Authors\n 8.10.3 Processors of Submitted Work\n 8.10.3.1 Advanced Degree Committees\n 8.10.3.2 Journal/Abstract Reviewers\n 8.10.3.3 Application Reviewers\n 8.10.3.4 Supervisory Reviewers\n 8.10.3.5 Honor Agency Reviewers\n 8.10.3.6 Predatory Publishers\n 8.11 Scientific Misconduct Cases\n 8.11.1 The Classic Scientific Ethics Course Case: The Piltdown Man\n 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)\n 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)\n 8.11.4 Data Fabrication. The William Summerlin Case\n 8.11.5 Threatening Human Life. The Andrew Wakefield Case (Adapted from and Gross )\n 8.12 The Bioengineering Scientist as a Professional\n9. Ethics of Research with Non-Human Animals\n 9.1 History of Animal Use by Humans\n 9.2 Changes in Human Link with Domestic Animals\n 9.3 The Animal Rights Movement\n 9.4 The Scientific Basis for Humane Treatment of Laboratory Animals\n 9.5 Development of Animal Research Regulations\n10. Health Professionals and Historic Human Research Ethics\n 10.1 The Tradition of Experimenting on Humans\n 10.2 The Tuskegee Syphilis Study\n 10.3 Nazi Use of Human Experimental Subjects\n 10.4 Japanese Army Experiments using Chinese Civilians in Ping Fan\n 10.5 Development of First Conventions Regulating Experiments using Human Subjects\n 10.6 The Nuremberg Code\n 10.7 The Helsinki Declaration and OPRR\n 10.8 The National Research Act and the Belmont Report\n 10.9 Humans Being Humans\n11. Health Professionals and Modern Human Research Ethics\n 11.1 The Industrial Revolution Creates a Drug Industry\n 11.2 Science, Medicine, and Technology Come Together after 1945\n 11.3 Medical Research in University and Pharmaceutical Laboratories\n 11.4 Science and Technology Create Biomedical Physicians\n 11.5 What Is Pre-Clinical Research?\n 11.6 What Is Clinical Research?\n 11.7 Case Study: Hyman v. Jewish Chronic Disease Hospital (JCDH) of New York and Informed Consent—Vulnerable Patients\n 11.8 Clinical Research and the Practice of Medicine\n 11.9 Impact of the \"Heyday of Drug Development\" on Medical Practice\n 11.10 Case Study: Possible Conflict of Interest in Research using Human Subjects\n 11.11 Non-Medical Scientific Research using Human Subjects\n 11.12 Naming the Third Pharmaceutical Epoch\n 11.13 Physicians in Practice and the FDA in the Third Pharmaceutical Epoch\n 11.14 Imaginary Case Study: Financial Conflict of Interest\n 11.15 Financial Conflict of Interest and the Grassley-Kohl Sunshine Act\n 11.16 Human Subject Disregard for Science (Based on an Account from )\n 11.17 The FDA as a Regulator of Research with Human Subjects\n12. Ethics of Medical Product Development\n 12.1 The Bioengineer as a Product Developer\n 12.2 Bioengineer, Engineer and Physician: The Medical Product Development Team\n 12.3 The Public and the Government Place Limits on Medical Products\n 12.4 A History of the FDA\n 12.5 FDA device classification (refer to https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ for a complete summary of device classification criteria)\n 12.6 Preclinical Testing\n 12.7 Publishing Pre-Clinical Test Results\n 12.8 Considerations That Enhance Success of Clinical Trials\n 12.9 Clinical Trials\n 12.9.1 Phase I\n 12.9.2 Phase II\n 12.9.3 Phase III\n 12.10 Protecting a Device or Drug as Intellectual Property\n 12.11 CRISPR Patent Case: Regents, University of California v. Broad Institute, Inc.\n 12.12 The Brave New World of Genomic Technology Clinical Research\n13. Ethics of Product Failure and the Courts\n 13.1 Phase III Monitoring of an FDA-approved Device Has No End Date\n 13.2 Enter the Lawyers\n 13.3 How Does a Device Failure Become a Court Case?\n 13.4 Intrauterine Device (IUD) The Dalkon Shield Case (1971) (after Mayesh and Scranton 2004)\n 13.5 The Artificial Heart Valve Cases (after Mayesh and Scranton 2004)\n 13.6 Metal-on-Metal ASR Case (after Cohen 2011)\n 13.7 Silicone Breast Implant Cases (after Schleiter 2010 and Hooper 2001)\n 13.8 Expert Witnessing and the Federal Rules of Evidence: Daubert v. Merrill Dow Pharmaceuticals (after SKAPP 2003)\n 13.9 Can the FDA Be Sued?\n 13.10 The Future of Data Care\nReferences\nGlossary\nAppendix A Suggested Format for Class Debates\nAppendix B Informed Consent\n Clinical Research\n Observational Study Consent Form\n Purpose of the Observational Study\n Reasons for the Observational Study\n What Will You Be Doing?\n Benefits and Risks\n Blood Draw\n Bone Density Measurement\n Urine Sample\n Costs\n Confidentiality\n Right to Withdraw\n Voluntary Consent\n Other Information\n Investigator\'s Statement\n Participant Statement\nAppendix C Advance Health Care Directive Example\n Part 1 Power of Attorney for Health Care\n Part 2 Instructions for Health Care\n Part 3 Donation of Organs, Tissues, and Parts at Death (Optional)\n Part 4 Primary Physician (Optional)\n Part 5\n Part 6 Special Witness Requirement\nAppendix D Research Misconduct Policy Example\n I References\n II Definitions\n III General Policy\n IV Procedures\n A Applicability\n B Allegations of Research Misconduct\n C Initial Assessment\n D Securing of Evidence\n E General Standards for Committees and Administrators\n F Conducting an Inquiry\n G Conducting an Investigation\n 1 Appointment of Committee\n 2 Investigation\n 3 Evidentiary Requirements for Findings of Research Misconduct\n H VCR\'s Determination of Research Misconduct\n I VCR\'s Other Notification Responsibilities\n V Attachments\n A Other Related Policies, Procedures, and Resources\nAppendix E Significant Events in the History of Experimentation With Human Subjects\nAppendix F Examples of Medical Device Report Incidents\nIndex