Volunteers in Research and Testing

Book Cover......Page 1
Half-Title......Page 2
Title......Page 4
Copyright......Page 5
Contents......Page 6
Foreword......Page 8
Acknowledgements......Page 10
List of Contributors......Page 11
Introduction......Page 12
1 The Volunteer Subject, Encouragement and Protection......Page 15
2 Consumers’ Viewpoint......Page 31
3 Human Volunteers in Research; A Physician’s Overview......Page 39
4 Clinical Research—The Relationship between Law and Guidelines......Page 46
5 Local Research Ethics Committees: A View from the Department of Health......Page 56
6 Recruitment, Selection and Compensation of Volunteers for Phase I Studies......Page 61
7 Volunteers: The Susceptible and the Disadvantaged......Page 68
8 The Use of Surrogate End-points in Volunteer Studies......Page 82
9 Whatever happened to Plain English? The Gobbledygook Smokescreen that baffles Research Subjects......Page 90
10 The Risks of Studies in Healthy Volunteers......Page 99
11 A Comparison of the Controls Regarding the Ethical Judgements on Animal and Human Research......Page 108
12 The use of Human Volunteers for Hazard and Risk Assessment of Skin Irritation......Page 115
13 Volunteer Studies using the Health and Safety Laboratory Exposure Chamber......Page 126
14 The Limits of Human Studies......Page 131
15 Magnetometry—The Ultimate Non-invasive Neurophysiological Technique......Page 140
16 Pharmacokinetic and Pharmacodynamic Assessment in Early Drug Development—Current Approches and Future Developments......Page 158
17 The European Dimension......Page 165
18 The Future of Ethics Committees......Page 172
Appendix One......Page 179
Appendix Two......Page 183
Appendix Three......Page 185
Index......Page 188