18 Clinical Research Ethics
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Zareen Bheekhun
Abstract
Clinical research is the controlled experimentation of drugs, devices, and procedures tested on human participants. Ethics of clinical research is the systematic investigation of the ethical issues that arise from this practice. The ethical knot at the centre of clinical research hinges on the question of how to balance the benefits for future patients with the burdens and risk for current participants. The chapter first discusses the roots and foundations of clinical research ethics through a historically informed outlook. We then present two key and interrelated concepts in research ethics: clinical equipoise and therapeutic misconception. Second, the chapter discusses the emergence of adaptive and platform trials in the COVID-19 pandemic and unpacks the ethical and epistemological implications of adaptive trials for the concepts of clinical equipoise, and therapeutic misconception, the long-standing idea in clinical research that we should strive to keep the aims of research and the aims of care as clearly separate.
Abstract
Clinical research is the controlled experimentation of drugs, devices, and procedures tested on human participants. Ethics of clinical research is the systematic investigation of the ethical issues that arise from this practice. The ethical knot at the centre of clinical research hinges on the question of how to balance the benefits for future patients with the burdens and risk for current participants. The chapter first discusses the roots and foundations of clinical research ethics through a historically informed outlook. We then present two key and interrelated concepts in research ethics: clinical equipoise and therapeutic misconception. Second, the chapter discusses the emergence of adaptive and platform trials in the COVID-19 pandemic and unpacks the ethical and epistemological implications of adaptive trials for the concepts of clinical equipoise, and therapeutic misconception, the long-standing idea in clinical research that we should strive to keep the aims of research and the aims of care as clearly separate.
Kapitel in diesem Buch
- Front Matter i
- Contents vii
- Series Editors’ Preface xiii
- List of Figures, Tables, and Boxes xiv
- Table of Cases xvi
- Table of Statutes xx
- Notes on Contributors xxii
- Introduction 1
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General Principles of Health Law and Ethics
- Ethical Principles in Health 27
- Defining and Understanding ‘Health’ in Health Law 49
- Health Inequalities, Law, and Society 69
- Health Disparities, Equity, and Pandemic Ethics 91
- Ethics, Health(care), and Climate Change 115
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The Body of Health Law
- Medical Negligence 135
- Medical Manslaughter 157
- Consent to Treatment 177
- Mental Capacity and Decision-Making 195
- Mental Health: Inpatient Care 217
- Confidentiality 235
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Applied Health Law and Ethics
- Assisted Reproduction 261
- Abortion and Contraception 281
- Pregnancy and Birth 301
- Capable Children’s Medical Treatment 323
- Organ Donation: Deceased Donation 343
- Clinical Research Ethics 363
- Death and Dying 385
- Index 403
Kapitel in diesem Buch
- Front Matter i
- Contents vii
- Series Editors’ Preface xiii
- List of Figures, Tables, and Boxes xiv
- Table of Cases xvi
- Table of Statutes xx
- Notes on Contributors xxii
- Introduction 1
-
General Principles of Health Law and Ethics
- Ethical Principles in Health 27
- Defining and Understanding ‘Health’ in Health Law 49
- Health Inequalities, Law, and Society 69
- Health Disparities, Equity, and Pandemic Ethics 91
- Ethics, Health(care), and Climate Change 115
-
The Body of Health Law
- Medical Negligence 135
- Medical Manslaughter 157
- Consent to Treatment 177
- Mental Capacity and Decision-Making 195
- Mental Health: Inpatient Care 217
- Confidentiality 235
-
Applied Health Law and Ethics
- Assisted Reproduction 261
- Abortion and Contraception 281
- Pregnancy and Birth 301
- Capable Children’s Medical Treatment 323
- Organ Donation: Deceased Donation 343
- Clinical Research Ethics 363
- Death and Dying 385
- Index 403
