This is the first volume to comprehensively discuss the ethical, regulatory, and social aspects of xenotransplantation research.
Organized into four parts, Xenotransplantation begins by examining ethical issues around informed consent of the potential xenograft recipient, the major ethical issues encountered when doing this research on pigs, and allocation issues. Part two examines regulatory aspects from a global perspective, specifically from three major regions of the world doing xenotransplantation research currently, of which include the United States, Western Europe, and Asia. Following this, part three describes religious aspects of xenotransplantation amongst the major world religions, including Christianity, Islam, Judaism, and Hinduism. The book closes with an analysis of quantitative and qualitative studies conducted by the editors that assess the public’s perception of xenotransplantation.
Featuring original data collected by the editors, this book is an instrumental resource for all clinicians involved in the research and practice of xenotransplantation.
Author(s): Daniel J. Hurst, Luz Padilla, Wayne D. Paris
Publisher: Springer
Year: 2023
Language: English
Pages: 284
City: Cham
Foreword
Preface
Contents
1: Introduction
Overview
Part I: Ethical Aspects
2: Allotransplantation Ethics
Introduction
Living Donations
Methods of Increasing Living Donation
Relaxation of Criteria to Become a Living Donor
Incentivizing Donors
Broadening the Range of Potential Donors
Deceased Donations
Types of Deceased Donation
Increasing Consent Rates for Deceased Donation
Expanding Categories of the Dead
Conclusions
References
3: Xenotransplantation: The Role of Public Involvement
Introduction
Individual and Public Health in Transplantation Technologies
Risks, Precaution, and the Public: From the Environment to Health Technologies
Consulting Citizens on Xenotransplantation
Debating the Public Dimension: Publics or Citizens?
Responsible Collaboration and Commitment: Merging Individual and Public Health After COVID-19
Some Provisional Conclusions for a Work in Progress
References
4: Xenotransplantation and Clinical Ethics
Introduction
Background of Clinical Ethics in Xenotransplantation
Autonomy, Patient Rights, and Informed Consent
Right to Withdraw
Right to Withdraw from Medical Treatment Adherence
Right to Withdraw from Post-Transplant Monitoring
Ulysses Contracts
Risks to Third Parties
Enforcement of Treatment and or Monitoring
Practical Considerations in Providing Informed Consent for Xenotransplantation
Pediatric Contexts
Justice, Equity, and the Allocation of Scarce Medical Resources
Allocation of Xenografts
Xenotransplant Failure, Relisting, and Retransplantation
Expanded Access
Fair and Equitable Access to Xenotransplantation
Conclusion
References
5: Xenotransplantation and Pediatric Ethics Issues
Introduction
Informed Consent
Research on Pediatric Perspectives and Ethical Issues
Experimental Therapeutic Research in Pediatrics
Conclusion
References
6: Xenotransplantation and Informed Consent
Introduction
Early History of Informed Consent
Informed Consent and Xenotransplantation
Community Consent
The Right to Withdraw
Conclusion
References
7: Geoethics and Xenotransplantation
Introduction
Geoethical Diversity as Practiced by Xenotransplantation Technologists
Geoethical Unity as Experienced by Xenotransplantation Participants
Geoethical Viability in the Context of Xenotransplantation
Practical Consequences of Geoethics for Xenotransplantation
Conclusion
References
8: Animal Ethics and Zoonosis Risks
Introduction
Animal Ethics
General Consideration
Animal Welfare
Genetic Engineering of Animals for Xenotransplantation
Animal Rights
Alternative Approaches to Usage of Animals
Xenotransplantation and Possible Impact of Pig Viruses
General Concepts on Pig Health Status and the Impact of Pig Derivation and Housing
Pig Health Status
Pig Derivation and Housing Impacts Circulating Viruses
Conventional High Health Pig Farm
Virus Transmission in Pigs to Assess the Potential of Introducing Viruses into Secure Research Facilities
Direct Pig-to-Pig Transmission or Vertical Transmission from the Dam to the Intrauterine Offspring
Indirect Transmission
Viruses in Pigs
Virus Populations in a Pig
Known Zoonotic Viruses
Lumbo Virus and Tahyna Virus
Reston Ebolavirus and Zaire Ebolavirus
Japanese Encephalitis Virus (JEV), Murray Valley Encephalitis Virus and West Nile Virus (WNV)
Hepatitis E Virus (HEV)
Influenza Viruses
Menangle Virus, Nipha Virus and Porcine Parainfluenza Virus 1 (PPIV1)
Rabies Virus
Eastern Equine Encephalitis Virus
Pig Viruses of Importance to Xenotransplantation
Porcine Circoviruses (PCV)
Porcine Lymphotrophic Herpesvirus (PLHV) and Porcine Cytomegalovirus (PCMV)
Encephalomyocarditis Virus (EMCV)
Swine Vesicular Disease Virus (SVDV)
Porcine Endogenous Retroviruses (PERV)
Cross Species Transmission Using the SARS-CoV-2 Example
General Concepts and Definitions
The SARS-CoV-2 Pandemic: An Example for Virus Cross-Species Transmission
Cross-Species Transmission of SARS-CoV-2 from Humans to Animal Species
Farmed Mink
Pigs
Summary and Conclusions
References
Part II: Regulatory Aspects
9: Regulatory Considerations and Oversight: A US Perspective
Introduction
History of Xenotransplantation Regulation
FDA Definition of Xenotransplantation
Current Paradigm for Regulating Xenotransplantation Products in the United States
CVM Oversight of Intentional Genomic Alteration(s) in Animals
Product Characterization
Phenotypic Characterization
Durability Assessment and Plan
Food Safety
Environmental Impact
Effectiveness
CBER Oversight of Human Biological Products
Source Herd
Source Animals for Xenotransplantation Products
Animal Welfare
Chemistry, Manufacturing, and Controls (CMC): Product Processing and Testing
Preclinical Assessments
Clinical Requirements
Additional Considerations for Xenotransplantation Products
Concluding Remarks
References
10: Regulatory Considerations and Oversight: A European Perspective
Introduction
Regulation of Xenotransplantation
Medicinal Products in Europe
Regulatory Oversight
Regulation: Safety
Regulation: Efficacy
Regulation: Genetic Modification
Archiving and Storage of Materials
Informed Consent
Xenogeneic Cell Transplantation
Xenogeneic Solid Organ Transplantation
Decellularized Products
The Role of the European Medicines Agency
Conclusions and Perspectives
References
11: Regulatory Considerations and Oversight: A Japanese Perspective
Introduction
Islet
Organ
Future Issues
References
12: Regulatory Considerations and Oversight: A Chinese Perspective
History and Current Status
References
Part III: Religious Aspects
13: Religious Viewpoints: Protestant and Catholic
Introduction
Xenotransplantation and the Initial Role of Theologians
Transplantation in Christian Thought
Xenotransplantation in Christian Thought
Empirical Data
Community Risk of Xenozoonosis Vs. Individual Benefit
Ways Forward
References
14: Religious Viewpoints: Sunni Islam
Introduction
Sources of Sunni Ethico-Legal Deliberation
Medication in Sunni Ethics and Law
Xenotransplantation and Its Relationship to Allotransplantation
Animal Use in Medication and Therapy in Sunni Ethics
A Note on the Status of Pig in Islam
A Sunni View on Xenotransplantation
Islamic Concerns: Potential Religious Objections to Xenotransplantation
Muslim Concerns: The Impact of Controversial Therapies
Conclusion
References
15: Religious Viewpoints: Shia Islam
Introduction
Shia Bioethics
The Principle of Necessity
The Principle of No Harm
The Principle of Original Permissibility
Even from a Pig?
Fatwas
The Problem of Daily Prayers: The Status of the Transplanted Tissue
A Flaw
Conclusions
References
16: Religious Viewpoints: Judaism
Introduction
The Relationship Between Jewish (Medical) Ethics and Jewish Law
Participating in Risky Procedures
Using (and Genetically Modifying) Animals for the Purpose of Medical Treatment
Pigs Are Not Kosher, and So Not Jewish
Pigs Are Not Kosher, but…
Jewish Pig Farms for Organ Transplant
Conclusion
References
17: Religious Viewpoints: Hinduism
Introduction
Divine Human-Animal Beings
Karma
Conclusion
References
Part IV: Social Aspects
18: Psychological Implications
Introduction
Psychological Factors in Allotransplantation
Intrapersonal Identity in Xenotransplantation
Interpersonal Identity and Relational Factors of Xenotransplantation
Social and Community Influences on the Psychological Acceptance of Xenotransplantation
The Ideal Psychological State for Xenotransplantation and Assessment Tools
Conclusion
References
19: Challenges in Adequately Assessing the Social Attitudes and Perceptions of the Public Towards Xenotransplantation
Xenotransplantation at Present
Assessment of Attitudes and Social Perceptions
Social Information on Xenotransplantation
Limitations in Understanding the Attitude and Social Perception Towards Xenotransplantation
Heterogeneous Studies with Different Tools to Measure This Situation
Low Quality of the Studies
There Are Few Studies That Analyze the Social Perception Towards Xenotransplantation
Difference Between Knowledge and Acceptance Towards Xenotransplantation
The Attitude and Social Perception Towards Xenotransplantation
General Evaluation of Studies Assessing Attitude and Social Perception
Social Perception Towards Xenotransplantation
Factors Associated with Attitude Towards Xenotransplantation
Studies of the International Collaborative Donor Project
Importance of the Health Profession in Raising Awareness of Xenotransplantation in the Population
References
20: Public and Patient Opinions on Xenotransplantation and Cell Therapy
Introduction
Solid Organ Acceptance
Hospital Staff
Stakeholders
Meta-Analysis
Students
Kidney Patients and Providers
Public Perceptions
Congenital Heart Surgeons, Cardiologists, Nurses and Parents of Children with Congenital Heart Disease
Racial Differences in Attitudes Among Parents
Cell Xenotransplantation Acceptance
Conclusion
References
21: Potential Applicability of Cardiac Xenotransplantation in Pediatrics: Just Around the Corner
Introduction
Infants and Neonates
Candidates for Xenotransplantation
Children of All Ages
Possible Consequences of Xenotransplantation
Next Steps
References
22: The Implications of Living as a Xenograft Recipient
Introduction
Relation to Allotransplantation
Patient, Staff, and Public Attitudes Towards Potential Clinical Trials
Psychosocial Implications for the Prospective Patient and Family
Suggested Clinical Trial Research Design
Summary
References
23: Clinical and Ethical Implications of Adult Cardiac Xenotransplantation
Introduction
Alternative Therapies to Cardiac Transplantation
Temporary
Durable
Limitations to Widespread Use
Potential Utility of Adult Cardiac Xenotranpslantation
Efficacy and Safety of Cardiac Xenotransplantation
Potential Cardiac Xenotransplantation Candidates
Ethical Implications of Adult Cardiac Xenotransplantation
Conclusions
References
24: Kidney Xenotransplantation
Introduction
Candidate Selection
Overcoming Barriers of Xenotransplantation
Immunosuppression
Public Acceptance of Xenotransplantation
Approaching Human Clinical Trials
Conclusion
References
Index
