DeRenzo / Moss Writing Clinical Research Protocols

Ethical Considerations
1. Auflage 2005
ISBN: 978-0-08-045420-7
Verlag: Elsevier Science & Techn.
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 320 Seiten, Web PDF

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. - Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol - Includes a chapter containing Case Histories - Contains information on conducting clinical research within the pharmaceutical industry - An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations - Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA

Autoren/Hrsg.

Derenzo, Evan

Moss, Joel

Inhaltsverzeichnis

1;front cover;1
2;copyright;5
3;table of contents;8
4;front matter;18
5;Preface;18
6;body;22
7;I The Basics: What You Need To Know Before Starting Human Subjects Research;22
7.1;1 Introduction To The Art And Science Of Clinical Research;24
7.2;2 What You Need To Know About Clinical Research Ethics;32
7.3;3 What You Need To Know About The Regulation Of Clinical Research;48
8;II Preparing The Protocol;62
8.1;4 Designing A Clinical Research Study;64
8.2;5 Selecting Subjects For Clinical Studies;84
8.3;6 Risks And Benefits In Clinical Research;118
8.4;7 Recruiting Subjects;140
8.5;8 Informed Consent;148
8.6;9 Privacy And Confidentiality;180
8.7;10 The “Ethics” Section;196
9;III Procedures, Methods, Statistics, Data Management, And Record Keeping;204
9.1;11 Procedures And Methods;206
9.2;12 Statistics, Data Collection And Management, And Record Keeping;228
10;IV Special Issues;242
10.1;13 Use Of Human Biological Materials;244
10.2;14 Special Issues Raised By Evolving Areas Of Clinical Research;258
10.3;15 Case Histories: Learning From Experience;282
11;back matter;290
12;Appendix: Web Resources;290
13;References;294
14;Glossary;302
15;index;312