Handbook of Bioethical Decisions. Volume I: Decisions at the Bench

Description

The Handbook of Bioethical Decisions is aimed at addressing and analyzing the most important ethical concerns and moral quandaries arisen in biomedical and scientific research. As such, it identifies and problematizes on a comprehensive range of ethical issues researchers must deal with in different critical contexts. Thus, the Handbook, Vol. I, may be helpful for them to make decisions and deliberate in complex practical scenarios. In this fashion, the volume reunites different points of view to give readers room enough to get a better knowledge and take their own position on pressing bioethical issues of the day. Consequently, this workseeks to engender dense ethical epistemology scientists can count on when conducting latest generation biomedical research. By bringing together an impressive array of contributions on the most important elements and categories for “at the bench” bioethical decisions as well as offering chapters by some of the most world renowned and prominent experts in bioethics, the Handbook, Vol. I, is a paradigmatic text in its area and a valuable resource for courses on bioethics, and biomedical research, as well as courses that discuss ethics and the biosciences at different professional levels, biomedical industry, pharmacological companies and the public sphere in general.  Foreword Acknowledgments Contents Editors and Contributors Contributors Chapter 1: Introduction: Biomedical Research in One World: Current and Future Challenges References Part I: Biomedical Research: Genetic and Cell Research Chapter 2: Learning from Icarus: The Impact of CRISPR on Gene Editing Ethics Introduction Brief History of Gene Editing and CRISPR What Is Ethically Unique About CRISPR? Who Owns CRISPR, and Does This Matter? Technical Concerns, Risks, and Benefits Transparency and Public Deliberation Informed Consent Playing God Solidarity and Justice Conclusion References Chapter 3: Bioethical Decision Making and Genome Editing Introduction Determining the Ethical Challenges for Human Beings Safety Concerns Distinguishing Different Personal Identities Non-heritable Genome Editing Heritable Genome Editing Advantages of Heritable Genome Editing Disadvantages of Heritable Genome Editing Decision-Making in a Practical Context Gene Editing of Very Early Embryos Genome Editing of Sperm, Eggs, and During Fertilisation On What Basis Should a Decision Be Made? Conclusion References Chapter 4: Therapeutic Genome Editing References Chapter 5: Bioethical Decision-Making About Somatic Cell Genome Editing: Sickle-Cell Disease as a Case Study Introduction What Are Somatic Cells? Somatic Cells and Disease Etiology Monogenic and Polygenic Diseases Historical Development of Somatic Cell Genome Editing Homologous Recombination Non-homologous End-Joining Nuclease-Mediated SCGE Ex Vivo, In Vivo and In Utero Applications of SCGE Bioethical Decisions About Nuclease-Mediated SCGE in General Sickle-Cell Disease Current Therapeutic Approaches to Sickle-Cell Disease Bioethical Decision-Making About Hematopoietic Stem Cell Transplantation-Based Cures for Sickle-Cell Disease The Nuclease-Mediated SCGE Approach to Sickle-Cell Disease Bioethical Decision-Making About Ex-Vivo Nuclease-Mediated SCGE Nonmaleficence Beneficence Autonomy Justice Conclusion References Chapter 6: Gene Therapy and Germline Cells Research Introduction How Is Germline Gene Therapy Technically Possible? Advancing Germline Genomic Editing Techniques Through CRISPR/Cas9, a Nobel Prize Winning Combination Gene Therapy: Definitions, Differentiations and Applications When Do We Really Talk About Germline Gene Therapy? One Step Beyond the Dichotomy Between Therapeutic and Non-Therapeutic Fear of a Eugenic Drift and the Controversial Violation of Human Dignity: Two Major Bioethical Objections to Germline Gene Therapy Does Eradicating Disease Mean Eradicating the Sick? Disabilites Rights Critique and Germline Gene Therapy Conclusions References Chapter 7: Bioethical Quandaries in Preimplantation Genetic Diagnosis Introduction Is It Ethical Using PGD to Select Healthy Embryos and Discard Those Carrying a Disease or Disability? Is Using PGD to Create a Savior Sibling Ethical? Is It Ethical Using PGD for Sex Selection? Is It Ethical That Disabled Parents Select for Disabilities? Selection of Embryos and Transhumanism: Is It Ethical Using PGD to Enhance Human Species? Final Remarks References Chapter 8: Rare Disease Research Introduction The Secondary Research Use of Rare Diseases Patients’ Data. Definition Ethical Aspects to be Considered (see Table 8.1) Patients’ Needs Scientific Research Public Interest The Rights of the Participants and Their Relatives The Ethically Relevant Aspects. Suggestions on How to Address Them Undiagnosed Disease: Between Medical Effort, Research And Clinical Ethics Therapies, Between Policies and Therapeutic Research Policies and Regulations of RD Treatments Research in the Treatment of RDs Genome Analysis in Newborn Screening References Chapter 9: Limits of Debate: Governance of Human Embryo Research and the Making of the Fourteen-Day Rule Introduction A Natural(ized) Limit From Facts to Reason Politics of the Limit Unlimiting Science Conclusion References Chapter 10: Human/Non-Human Chimeras Introduction Three Preliminary Debates: Chimeras Vs. Hybrids, Animal-Human Chimeras and Chimeras Non Affecting Particularly Relevant Features Reasons Concerning the Rights and Interests of the Entities Involved in the Research Reasons Concerning the Rights and Interests of the Resulting Entities Reasons Related to Human Dignity and the “Species Integrity” Argument Reasons Concerning Downstream Effects A Last and Extremely Challenging Argument Conclusion References Chapter 11: Human Cloning: Recent Advances and Bioethical Issues Cloning – Scientific Perspectives Therapeutic and Reproductive Cloning Reproductive Cloning, Then and Now In Vitro Fertilization (IVF) Human Embryo Cultivation Regulations Human Cloning and Ethics Stakeholders in Human Cloning Issue Ethical Issues Is Genetic Variability Outdated as an Ethical Issue? Religious Perspective Case-Based Approach to Human Cloning Case A Case B Case C Laws, Regulations, and Policies Conclusion References Part II: Biomedical Research: Enhancement Research Chapter 12: The Evolutionary Optimality Challenge Introduction The Evolutionary Optimality Challenge The Starting Point of Our Evolution Heuristic Is to Pose the Evolutionary Optimality Challenge We Propose that There Are Three Main Categories of Possible Answers to the EOC: Altered Tradeoffs, Evolutionary Incapacity, and Value Discordance Altered Tradeoffs Evolutionary Incapacity Value Discordance Altered Tradeoffs Changes in Resources Changes in Demands Evolutionary Incapacity Fundamental Inability Local Optima Lags Value Discordance Good for the Individual Good for Society The Heuristic Discussion Conclusion References Chapter 13: Mood Enhancement Introduction The First Issue: Side-Effects for the Agent Second Issue: Access to Medication Normalization, Coercion and Paternalism Naturality and Authenticity Conclusions References Chapter 14: Superior Sport Performance: Ethical and Legal Issues Cognitive and Emotional Enhancement in Sport Some Preliminary Concepts: “Doping” Versus the So-Called “Doping in Everyday Life” The Case of Cosmetic Interventions The Case for Increasing Sexual Capabilities The Case of Students and the Improvement of Intellectual Capacity Doping in Everyday Life Contexts Gene Doping. A Paradigmatic Case Conceptual Approach to Gene Doping Normative Position: The World Anti-Doping Agency (WADA) Our Position. Gene Doping and Distinction of Related Figures Mood Enhancement as a Category Within Human Enhancement or Enhancement Interventions in Sport Some Ethical & Legal Paradigms of Human Enhancement Interventions in Sport Concluding Reflections and Openness to New Questions References Chapter 15: Arguments Over Life Extension in Contemporary Bioethics Introduction Bioethics in Postmodernity “Bioethics as a Plural Noun” Postmodern Liberalism and Public Bioethics Arguments for the Contingent Undesirability of LE Arguments for the Necessary Desirability of LE The “More Is Better” Argument for LE The Transcendental Argument for LE The Transhumanist Argument for LE Arguments for the Necessary Undesirability of LE Anti-LE Arguments from Religion Secular Anti-LE Arguments from Human Nature Anti-LE Arguments from Meaninglessness Conclusion References Part III: Biomedical Research: Research with Human Biological Samples and Health Data Chapter 16: Research with Human Biological Samples: Systematization of the Phases and Affected Rights Introduction General Approach Normative Framework The Collection and Donation Phase of the Sample Rights Involved in Sampling: Physical Integrity and Disposition of Body Parts Withdrawal of Consent The Use of Data Resulting from Sample Analysis and Data Associated with Samples International Circulation of Samples Deacesed Persons Samples Minors Samples Governance, Policies and Guarantees: Biobanks Biobanks’ Structure Procedures and Guarantees of the Rights of Subjects Conclusions References Chapter 17: Biobanks for Biomedical Research: Evolution and Future Introduction Concept and Classification of Biobanks First Stage of Biobanks’ Evolution: Governance’s Challenges Informed Consent for Biobanking: Broad and Dynamic Consent Secondary Use of Data and Biological Samples The Right to Withdraw Consent Privacy and Confidentiality International Data Sharing Communication of Results and Disclosure of Incidental Findings Second Stage of Evolution: Harmonization and Collaborative Networks Countries with Specific Legislation on Biobanks Countries with General Legislation Applicable to Biobanks International and Regional Guidelines on Biobanking Biobanks Networks Third Stage of Evolution: Challenges for Sustainable Biobanking Sustainability Problems Dimensions of Biobank Sustainability Final Remarks References Chapter 18: Biobanking in Global Health & Research Biobanking & Ethics What Is Biobanking? Biobanking & International Guidance The Nagoya Protocol WHO: Guidance for Managing Ethical Issues in Infectious Disease Outbreaks The Declaration of Helsinki and CIOMS International Ethical Guidelines for Health-related Research The Taipei Declaration Case Study: Biobanking During the 2014 Ebola Outbreak in Sierra Leone Bioethics & Biobanking Misconceptions About Biobanking Unknown Consequences for Donors Socioeconomic Inequities That Increase Vulnerability Lasting and Proportional Benefits Contextual Challenges to Disclosure and Understanding Conclusion References Chapter 19: Ethical and Legal Considerations in Genomic Data Sharing: Evolution of the Discourse and the Road Ahead Introduction History and Rationale for Genomic Data Sharing Building Publicly-Funded Community Resources Open Science Improving Patient Care in Clinical Genomics Privacy Risks Data Access Governance Governance of Genomic Data Sharing Networks Informed Consent for Genomic Data Sharing and Research Use Presumed Consent Broad Consent Dynamic Consent Conclusions References Part IV: Biomedical Research: Biomedical Challenges in Research Chapter 20: Human Challenge Trials in Pandemics: Risks and Benefits Introduction Arguments For Arguments Against Policy Risks and Benefits Assessment Scientific Justification Consultation and Engagement Coordination of Research Informed Consent Final Remarks References Chapter 21: Ethical Considerations for Vaccine Research Vaccine Clinical Trials Are Not Usually Conducted in Combination with Healthcare Compensation and Payment to Vaccine Study Participants The Preventive Misconception Participant Commitment and Continuous Consent Process in Vaccine Trials Post-Trial Access in Vaccine Trials Controlled Human Infection Models Special Populations in Vaccine Studies Vaccine Community-Based Studies Final Considerations References Chapter 22: Global Health Partnerships and Emerging Infectious Diseases Introduction What Is Structural Justice? Structural Justice and Injustice Central Human Capabilities Minimally Decent Lives Structures for Global Health Security Structural Justice and Injustice During the COVID-19 Pandemic Pandemic Preparedness Vaccine Allocation Next Steps: Global Health Partnerships The Scope of Global Health Partnerships Next Steps Conclusion References Chapter 23: Precision Medicine Precision Medicine Definition, Delimitation and the Translational Turn Setting the Stage for Bioethical Analysis Characteristics of Data-Driven Precision Medicine The Changing Circumstances of Bioethical Issues Ethical Concerns and Moral Quandaries Justifying Data Processing The Changing Role of Patients in Precision Medicine Informed Consent Particular Issues Related to Privacy, Confidentiality and Disclosure Data Security as a Reaction to Risks and Balancing Interests Anonymisation Return of Results New Tools in Precision Medicine: Emerging Ethical Challenges Through Artificial Intelligence and Neurotechnology Governance: Ethics and Law References Chapter 24: The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues An Overview of Health Care AI Obtaining Data for Health AI AI Development: Data Representativeness and Algorithmic Bias Using AI: Is Informed Consent Required? Oversight of Health AI Conclusion References Part V: Animals, Food and Environment: Using Animals in Scientific Research Chapter 25: The Use of Animals in Basic Biological Research Brief History and Importance of Animal Testing in Biomedical Research Validation of Animal Models Predictive Validity Face Validity Construct Validity Ethical Concerns and Animal Protection Movements Legislation for the Use of Animals in Research and the Creation of Animal Welfare Oganizations The 3 R’s Replacement Reduction Refinement Final Considerations References Chapter 26: The Use of Animals in the Study of Human Disease: Key Roles of General Ethical Principles Introduction Aims of the Chapter Preliminary Definitions and Considerations Importance of Ethical Issues in HHAR Stages of Laboratory HHAR General Ethical Principles and the Diversity and Complexity of HHAR General Principles as Justifications General Principles in Sets of Ethical Standards General Principles in Statements of Central Obligations and Ideals An Instructive Example: The US Principles Core General Principles and the Central Ethical Structure of HHAR The Ethical Core of HHAR Presentation of the Core Established Core Ethical Principles and Supporting Facts Established Foundational Core Principles and Supporting Facts Established Basic Core Principles and Supporting Facts Animal Harm and Its Justification in HHAR Pain, Distress, and Other Significantly Unpleasant Sensations and Feelings as Harm Justification of Pain, Distress, and Other Significantly Unpleasant Sensations and Feelings Importance of Studying the Disease Scientific Soundne of the Study Likelihood of a Valuable Result Minimization of Pain, Distress, and Other Significantly Unpleasant Sensations and Feelings Justification of Debatably Harmful or Nonharmful Practices Killing Research Animals Caging or Confinement Potentially Emergent Core Ethical Principles Adoption of Healthy Animals: Possible Core Justifications Providing Pleasurable Experiences Stronger Justification for Use of Certain Species References Chapter 27: Ethical Issues Concerning Genetically Modified Animals for the Study of Human Diseases Introduction Genetic Modifications in Experimental Animals and the Study of Human Diseases Transgenesis Genome Editing Applications of Genetically Modified Organisms in Human Disease Modeling Ethical Issues Research in Animal Models Findings Cannot Be Extrapolated Completely to the Human Condition Risks or Unwanted Consequences Impacts on Animal Welfare Limits Between Artificial and Natural Intrinsic Value Justification References Chapter 28: Of Mice-Rats and Pig-Men: Ethical Issues in the Development of Human/Nonhuman Chimeras Introduction The Unnaturalness Argument The Aristotelian Argument The ‘Yuck Factor’ Argument The Moral Confusion Argument The Human Dignity Argument The Moral Status Argument The Mainstream Approach to Animal Ethics The Moral Status of Human/Nonhuman Chimeras Criticisms of the Mainstream Approach Alternative Grounds for the Ethical Treatment of Human/Nonhuman Chimeras Regulating Chimeric Research Conclusion References Chapter 29: Animals in Research in the Pharmaceutical Industry Animals as Models for Humans Vivisection and Governance Essentials of Translation Ethics of Translatable Models Summary References Chapter 30: Use of Animals in Toxicity Studies Introduction History of Laboratory Animal Use and Animal Testing Animals in Toxicity Testing Scientific and Regulatory Dissatisfaction with Animal Testing Economic & Time Factors The Ethics of Toxicological Testing References Chapter 31: Ethical Issues from the Use of Animals in the Cosmetics and Fashion Industries Introduction Culture of Needs and Desire Autonomy, Fashion and Cosmetics Fur Protests Industry and Captive Animals Killing of Endangered Animals and Environmental Concerns Research and Development of Modified Animals and New Products Cultural Diversity, Ethics of Destruction and Shaping a Moral Community Legal Evolution and Recognition of Animals References Chapter 32: Is It Time to Phase Out the Use of All Nonhuman Primates in Invasive Research? Introduction Background Primates’ Moral Status Justifying Primate Research Social Benefits of Research Primate Welfare Concluding Remarks References Chapter 33: Growing Human Organs Inside Animals Chimeras: From Mythology to Science Human Organ Donation and Chimeric Transplantation Ethical Concerns Crossing Species Boundaries Moral Status Regulatory Possibilities The Work Ahead References Chapter 34: Animal Cloning: Scientific Endeavour, Perception and Ethical Debate Introduction Animal Cloning – The Echinoderms and Amphibian Beginnings Sea Urchins, Salamanders, Leopard and African Clawed Frogs Animal Cloning – Leporine, Murine, Ovine and Bovine Animal Cloning Breakthrough: Megan, Morag, Cedric, Cecil, Cyril, Tuppence, Taffy, Tweed and Dolly, Polly and Molly Animal Cloning Methodology Generation of A Cytoplast via Enucleation/Bisection Selection of A Diploid Donor Cell and Their Cell-Cycle Stage Cell Cycle Co-ordination in Nuclear Transfer Reconstructed Embryos Embryo Reconstruction, Activation and Culture In Vitro Embryo Culture Embryo Selection and Transfer to Synchronised Recipient Applications and Improvements to Animal Cloning Genetic Engineering Using Animal Cloning Technology Renaissance – Animal Cloning and Genome Editing With Designer Nucleases Disruptive Technologies That Impede Animal Cloning Developments Embryonic Stem Cell (ESC) Technologies Induced Pluripotent Stem Cells (Ipscs) Restoring the Epigenetic Landscape Following SCNT Histone Acetylation DNA Methylation Genomic Imprinting Paternal and Maternal-Specific Nuclear Reprogramming Strategies Ethical Considerations and Rationale for Animal Cloning Food and Safety – Debbie, Denise, Dianna and Daisy Conclusion: Animal Cloning, Gene Editing and Genetic Modification References Part VI: Animals, Food and Environment: Decision Making and Alternatives to Animal Use in Research Chapter 35: Replacement, Reduction and Refinement: Ethical Considerations in the Current Applications of the 3Rs Introduction The Value of the Individual and Its Ethical Implications Where Are We Going? Brief History of the 3Rs Application of the 3Rs and Their Ethical Implications Replacement Reduction Refinement Challenges Associated to the Use of Animals in Research The New Rs and the Future of Animal Research Final Remarks References Chapter 36: Integrating Human and Nonhuman Research Ethics Introduction The Human Paradigm The Nonhuman Paradigm The Cultural and Institutional Context Double Standards and Pseudo-Problems Toward an Integrated Moral Framework Assessing This Integrated Moral Framework References Chapter 37: Regulation of Animal Research Introduction Objectives of the Regulation of Animal Research Relevant Guidelines and Declarations World Organisation for Animal Health (OIE) Cioms, Iclas and Iaclam Farm Animal Welfare Council (FAWC) The Cambridge Declaration on Consciousness Relevant Regulations European Regulations United States of America Animal Welfare Act The Public Health Service (PHS) Policy United Kingdom Other Relevant Regulations Worldwide Other Agencies and Associations Guidelines American Association for Laboratory Animal Science (AALAS) Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Federación de Sociedades Sudamericana de Ciencia en Animales de Laboratorio (FESSACAL) The Federation of European Laboratory Animal Science Associations (FELASA) American Veterinary Medical Association (AVMA) The Guide for the Care and Use of Laboratory Animals (The Guide) Institutional Animal Care and Use Committee (IACUC) and Equivalent Committees Animal Care and Use Program Conclusions References Part VII: Animals, Food and Environment: GMOs for Global Challenges Chapter 38: Ethical Issues in Genetically Modified Foods: From Transgenesis to CRISPR-Cas9 Genome Editing Technology Introduction Ethical Issues in GM Foods Human Health Natural Environment Society CRISPR-Cas9 and GM Foods Concluding Remarks References Chapter 39: GMOs and Human and Environmental Safety The Stakes The Starting Gun Ag-Biotech The Failure – A Reality Check Chemical Abuse and the Expected Rise of Superweeds Expected Effect of Evolution: The Rise of Superbugs Super Spread – Transgene Contamination Causes Economic, Societal and Environmental Harm Failed GM Traits The ‘Success’ of Biotech Amyris Solazyme Oxytec – Intrexon Conclusions References Chapter 40: GMOs and Sustainable Agriculture Introduction Principles of Sustainable Agriculture Sustainable Applications of GMOs Unsustainable Applications of GMOs Conclusions References Index