The Ethics of Rapid Tissue Donation (RTD): Constructing a Formal and Substantial Informed Consent Process (The International Library of Bioethics Book 85)

"This book offers a reflection on the central role that the ethics of informed consent plays in Rapid Tissue Donation (RTD). RTD is an advanced oncology procedure that involves the procurement, for research purposes, of fresh tissues within two to six hours of a cancer patients death. Since RTD involves the retrieval of tissues after death, and since the collected tissues are of great importance for medical research, the need for any form of informed consent to regulate this procedure has been questioned. This book argues for the necessity of informed consent to govern RTD, and it provides the reader with a bespoke informed consent process applicable to cancer patients. The analysis unfolds at the intersection between applied ethics, public health ethics, and clinical ethics, and it is informed by philosophical theories of informed consent and by the social implications of individual choices. By viewing medical issues relating to informed consent in oncology from an ethical perspective, the book combines philosophical analysis with discussion of concrete cancer-related issues. As a result, the book is suitable for readers interested in ethical reasoning as well as for those with a medical background. It contributes to contemporary research by offering an original analysis that relies on a rigorous philosophical approach to address innovative issues at the cutting edge of medical research and policy making." -- Provided by publisher Acknowledgements Introduction References Contents 1 Rapid Tissue Donation (RTD) for Oncology Research 1.1 Precision Medicine 1.2 Precision Medicine in Oncology 1.3 Tissue Biopsies 1.4 Rapid Tissue Donation (RTD) 1.5 Research Benefits of Postmortem Vs. Antemortem Tumor Specimens References 2 Two Senses of Informed Consent 2.1 Rapid Tissue Donation (RTD) and Informed Consent 2.2 The Hippocratic Oath 2.3 The Evolution of the Hippocratic Paradigm 2.4 Two Senses of Informed Consent as a Framework 2.5 The Salgo Case and the Formal Sense of Informed Consent 2.6 Informed Consent as a Core References 3 An Informed Consent for RTD? the Ethics of Postmortem Procedures 3.1 Formal Sense of Informed Consent for RTD 3.2 The Four Principles as a Framework 3.3 Is There a Need for Informed Consent to Govern RTD? 3.4 Against the Need for Informed Consent to Govern RTD 3.4.1 Hillel Steiner: The Dead Have no Rights 3.4.2 Spital and Erin 3.5 Duty to Make One’s Body Available for the Sake of Science: No Consent Requirement 3.5.1 Duty of Fairness 3.5.2 Duty to Personally Contribute to Public Goods 3.5.3 Duty to Avoid Free-Riding 3.5.4 Duty of Beneficence 3.5.5 Duty of Easy Rescue 3.6 Arguments for the Need for an Informed Consent to Govern RTD 3.6.1 Joel Feinberg 3.6.2 Ernest Partridge 3.7 Conclusion References 4 An Informed Consent for RTD? Honoring the Wishes of the Once-Alive 4.1 Introduction 4.2 The “Once-Alive” 4.3 RTD and Organ Donation: Benefits to Society 4.4 Concerning the Duty of Fairness and the Duty to Contribute to Public Goods 4.5 Concerning the Duty to Avoid Free-Riding 4.6 Concerning the Duty of Beneficence 4.7 Concerning the Duty of Easy Rescue 4.8 The Need for Informed Consent to Govern RTD References 5 Informed Consent and Research 5.1 Difference Between Research and Care: Ethical Issues 5.2 Regulations and Codes for Research Involving Humans 5.3 Oncology Research as a Framework for RTD 5.4 Informed Consent for Oncology Research and the Belmont Report’s Requirements 5.5 Information: Ethical Issues 5.6 Comprehension: Ethical Issues 5.6.1 Appreciation of Benefits 5.6.2 Risk/Benefit Evaluation 5.7 Voluntariness: Ethical Issues 5.7.1 Manipulation 5.8 Conclusion References 6 The Clinical Ethicist 6.1 The Clinical Setting and the Need for Guidance 6.2 The Birth of Ethics Committees to Address Clinical Issues with Ethical Implications 6.3 Core Ethical Principles 6.4 Different Kinds of Clinical Ethics Consultations 6.5 Approaches to Clinical Ethics Consultations 6.6 The Clinical Ethicist in the Oncology Setting 6.7 The Role of the RTD Ethicist References 7 Informed Consent for RTD: An Overview 7.1 Introduction 7.2 Step I—Picking the Right Timing for the First Discussion 7.2.1 At the Moment of Diagnosis 7.2.2 At the Moment When Cancer Becomes Terminal 7.2.3 A Burdensome Background: Considering Possible Solutions 7.3 Step II—Choosing the Right Spokesperson 7.3.1 The Treating Physician 7.3.2 Ethics Consultants 7.4 Phase Zero 7.5 Phase One 7.6 Phase Two 7.7 Phase Three 7.8 Vulnerable Populations and RTD 7.8.1 Adults with Limited Decision-Making Capacity 7.8.2 Minors 7.9 Informed Consent to Personal Data Processing References 8 Informed Consent for RTD: A Closer Look at Ethical Issues 8.1 A Multi-phased Informed Consent Process 8.2 RTD as an Agreement Between Patients and Science 8.3 Consent Withdrawal 8.4 The Role of Next of Kin in Consent Withdrawal 8.5 How Can Retrieved Samples Be Traced Back to Donors? 8.6 Possible Uses in Research of Tissues 8.7 Incidental Findings 8.8 Concrete Chance of Translation into New Treatment Available for the Donor Patient 8.9 Forms of Altruism 8.10 Different Kinds of Benefits 8.11 Compensation for RTD 8.12 Timing and Logistics of Cadaver’s Return to Families References Conclusion Appendices Index