Children and clinical research: ethical issues

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ISBN: 978-1-904384-31-1

Table of Contents
Nuffield Council on Bioethics ................................................................................................. iii
Acknowledgments .................................................................................................................. v
Foreword .............................................................................................................................. vii
Members of the Working Party .............................................................................................. ix
Terms of reference ................................................................................................................ xi
Summary and conclusions .................................................................................... xv
Introduction ............................................................................................................................ 1
Chapter 1 – Context and ethos ................................................................................ 8
Introduction ............................................................................................................................ 9
The context of clinical research with children and young people .......................................... 12
Ethos of the report ............................................................................................................... 22
Chapter 2 – Being invited to take part in research: evidence and law ............... 30
Introduction .......................................................................................................................... 31
How children, young people and families make decisions in practice ................................... 31
Making decisions: the law and international guidance .......................................................... 49
Chapter 3 – Developing research proposals: law and practice .......................... 66
Introduction .......................................................................................................................... 67
What research takes place and why? ................................................................................... 68
Checks and balances: promoting high quality research........................................................ 79
Practical constraints on research ......................................................................................... 93
Chapter 4 – An ethical approach to children’s involvement in research ........... 98
Introduction: scope and methodology................................................................................... 99
What is (ethically) different about children and young people? ........................................... 100
The role of parents ............................................................................................................. 101
Decision-making in the paradigm cases ............................................................................. 112
Challenging vulnerability .................................................................................................... 122
Chapter 5 – Developing research proposals: professionals’ responsibilities 128
Introduction ........................................................................................................................ 129
The role of professional virtues .......................................................................................... 129
Professional responsibilities in developing research .......................................................... 132
Professional responsibilities when reviewing research ....................................................... 134
Drivers of research ............................................................................................................. 142
Chapter 6 – Taking part in research: professionals’ responsibilities .............. 148

Introduction ........................................................................................................................ 149
Responsibilities to children and young people.................................................................... 150
Responsibilities to children and parents together ............................................................... 157
Responsibilities in the absence of parents ......................................................................... 164
Chapter 7 – Concluding thoughts ........................................................................ 172
Striking the right balance: conceptual recommendations ................................................... 172
Making research part of everyday life ................................................................................ 176
Appendices ............................................................................................................ 179
Appendix 1: Progress in leukaemia research ..................................................................... 180
Appendix 2: Method of working .......................................................................................... 183
Appendix 3: Wider consultation for the report .................................................................... 189
Appendix 4: ‘Youth REC’ films ........................................................................................... 198
Appendix 5: Young people’s resources arising from this report .......................................... 200
Appendix 6: The Working Party ......................................................................................... 204
List of abbreviations ........................................................................................................... 207
Index .................................................................................................................................. 209