Manchester University Press
11 Children in clinical trials in Ireland
Abstract
This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the prospect of a direct benefit and the provisions around child assent and parental consent. The chapter examines legal and ethical guidance regarding these issues, setting out areas of uncertainty and ambiguity between the various governing instruments. It argues that the lack of clarity in these areas needs to be addressed in order to provide a robust system of protection for children, parents and those involved in clinical research with children. It makes proposals for reform drawing on the legal, ethical and academic guidance in the area and best practice in other countries.
Abstract
This chapter focuses on two key areas which require further clarity and elaboration in the context of research with children, namely, the requirements for research which does not offer the child the prospect of a direct benefit and the provisions around child assent and parental consent. The chapter examines legal and ethical guidance regarding these issues, setting out areas of uncertainty and ambiguity between the various governing instruments. It argues that the lack of clarity in these areas needs to be addressed in order to provide a robust system of protection for children, parents and those involved in clinical research with children. It makes proposals for reform drawing on the legal, ethical and academic guidance in the area and best practice in other countries.
Chapters in this book
- Front matter i
- Contents v
- Contributors vii
- Series editor’s foreword x
- Introduction 1
-
Part I Context and care
- 1 Reproductive justice in Ireland 9
- 2 Conscientious objection, harm reduction and abortion care 24
- 3 Why care about carers? 41
-
Part II Rights and responsibilities
- 4 The limits of autonomy 55
- 5 If they can consent, why can’t they refuse? 71
- 6 Patient autonomy and responsibilities within the patient–doctor partnership 84
- 7 Older people, human rights, law and policy 101
- 8 Legal and ethical considerations in involuntary admissions to long-term care 117
-
Part III Regulating research
- 9 Retention and use of human biological samples 135
- 10 A moral gap? 150
- 11 Children in clinical trials in Ireland 163
-
Part IV Oversight of decision-making
- 12 Governance failures and organisational ethics 179
- 13 Psychiatric admission in Ireland 194
- 14 Protecting rights in mental health law 208
- 15 Patient-centred dying 222
- 16 Improving end-of-life care in intensive care units 236
- Index 251
Chapters in this book
- Front matter i
- Contents v
- Contributors vii
- Series editor’s foreword x
- Introduction 1
-
Part I Context and care
- 1 Reproductive justice in Ireland 9
- 2 Conscientious objection, harm reduction and abortion care 24
- 3 Why care about carers? 41
-
Part II Rights and responsibilities
- 4 The limits of autonomy 55
- 5 If they can consent, why can’t they refuse? 71
- 6 Patient autonomy and responsibilities within the patient–doctor partnership 84
- 7 Older people, human rights, law and policy 101
- 8 Legal and ethical considerations in involuntary admissions to long-term care 117
-
Part III Regulating research
- 9 Retention and use of human biological samples 135
- 10 A moral gap? 150
- 11 Children in clinical trials in Ireland 163
-
Part IV Oversight of decision-making
- 12 Governance failures and organisational ethics 179
- 13 Psychiatric admission in Ireland 194
- 14 Protecting rights in mental health law 208
- 15 Patient-centred dying 222
- 16 Improving end-of-life care in intensive care units 236
- Index 251
