Biotech Animals in Research: Ethical and Regulatory Aspects

Cover
Half Title
Title Page
Copyright Page
Table of Contents
Authors
Contributors
1 Introduction
	1.1 Ethical Concerns Related to GM Animals
	1.2 A Brief Historical Overview
	1.3 The Relevance of the Subject
	1.4 Tips for Reading
	References
2 The Science Behind GM Research Animals
	2.1 Introduction
	2.2 Technologies
		2.2.1 Success Rates
	2.3 Relevance of Research Animals
	2.4 Possibilities in the Future
	References
3 An Overview of the Regulation of Genetically Altered Animals in Research
	3.1 Introduction
	3.2 What is an Animal?
	3.3 What Does “Modified/Altered” Mean?
	3.4 What is “Research”?
	3.5 Governance Versus Regulation
	3.6 The Special Case of Non-Human Primates
	3.7 Compendium of the Laws, Regulations, and Standards Pertaining
to Research Involving Genetically Modified Animals
		3.7.1 Europe
			3.7.1.1 The European Union (EU)
			3.7.1.2 Great Britain (GB)/United Kingdom (UK)
		3.7.2 Israel
		3.7.3 North America
			3.7.3.1 Canada
			3.7.3.2 United States of America (US)
			3.7.3.3 Mexico
		3.7.4 South America
			3.7.4.1 Argentina
			3.7.4.2 Brazil
			3.7.4.3 Chile
		3.7.5 Asia and South Asia
			3.7.5.1 Japan
			3.7.5.2 China
			3.7.5.3 South Korea
			3.7.5.4 India
		3.7.6 Oceania
			3.7.6.1 Australia
			3.7.6.2 New Zealand
			3.7.6.3 Singapore
			3.7.6.4 Malaysia
	3.8 Conclusions
	Notes
	References
4 Welfare and 3Rs
	4.1 Introduction
	4.2 What is Animal Welfare?
		4.2.1 The Functioning-Based Paradigm
		4.2.2 The Feelings-Based Paradigm
		4.2.3 The Natural-Living Paradigm
		4.2.4 Integration of the Paradigms
	4.3 Applied Frameworks for Animal Welfare
		4.3.1 Animal Welfare in Laboratory Animal Science: The 3Rs
		4.3.2 Perspectives of the 3Rs, Animal Welfare and GM
		4.3.3 Refinement: Contingent vs. Deliberately Induced Suffering
		4.3.4 Could GM Help Refine and Improve Animal Welfare?
		4.3.5 Will GM Result in Reduction?
		4.3.6 Will GM Result in Replacement?
	4.4 The Three Cases
	4.5 Conclusion: Ethical and Epistemological Perspectives
	References
5 Beyond Welfare
	5.1 Introduction
	5.2 Ethics as Critical and Systematic Reflection
	5.3 Normative Ethical Theories
	5.4 Who is of Ethical Importance?
	5.5 Is Welfare All That Matters?
	5.6 Does the Death of Animals Matter?
		5.6.1 Death as a Welfare Issue: The Experience of the Animal
		5.6.2 Death as a Welfare Issue Disregarding the Experiences
of the Animal During the Process
		5.6.3 Death as an Ethical Issue Disregarding the Experiences  of the Animal During the Process, Albeit Not a  Welfare Issue
		5.6.4 Closing Remarks
	5.7 Do Animals Have Integrity?
		5.7.1 The Difference Between Naturally Occurring and Human-Induced Changes
		5.7.2 Integrity as a ‘More-or-Less’ Concept
		5.7.3 But where is Integrity Situated?
		5.7.4 Closing Remarks
	5.8 So… Where Does This Leave Us?
	References
6 A Utilitarian Perspective on Animal Experimentation Involving Genetic Modification
	6.1 Introduction
	6.2 Ethics and Moral Theories
	6.3 Utilitarianism
	6.4 Evaluating the Cases
	6.5 Conclusion
	References
7 Animal Rights View
	7.1 Definition: Animal Rights View
	7.2 Background and Content
	7.3 Case Studies: Animal Rights Evaluation
		7.3.1 Are the Research Animals Involved Sentient Creatures?
		7.3.2 How are the Rights of the Involved Sentient Animals Affected?
		7.3.3 Exceptions and Other Arguments to Justify Animal Rights Violations
	7.4 The Animal Rights View and the Morality of Breeding Animals
	7.5 Conclusion and Outlook
	Notes
	References
8 The Virtues and Vices of Germline Editing Research
	8.1 Virtue Ethics
	8.2 Virtue Ethics and Animal Experimentation
	8.3 Virtues, Vices, and Gene-Edited Mice and Mosaicism
	8.4 Virtues, Vices, Gene-Edited Zebrafish, and Heterotaxy
	8.5 Virtues, Vices, Gene-Edited Monkeys, and Duchenne’s Muscle Dystrophy
	8.6 Shared Moral and Intellectual Vices
	References
9 An Ethic of Care Critique of Induced Genetic Mutation in Animals
	9.1 Ethics of Care
	9.2 Gene-Editing Mice to Induce Albinism
	9.3 Gene-Editing Zebrafish to Rearrange Their Internal Organs (Heterotaxy)
	9.4 Gene-Editing to Induce Muscular Dystrophy in Rhesus Monkeys
	References
10 The Privileged Ones
	Notes
	References
11 The Ethical Assessment Process
	11.1 Introduction: Ethical Review and GM
		11.1.1 Different Structures of Animal Ethics Committees
		11.1.2 Requirements and Challenges Regarding the Ethical Review
	11.2 The Review Process: The Harm-Benefit Analysis (HBA)
		11.2.1 Models of Harm-Benefit Analysis
	11.3 Who Participates in the Ethical Review on Animal Research?
	11.4 Conclusions and Implications
	References
Appendix
Index