Writing Clinical Research Protocols (eBook)

Ethical Considerations

Evan DeRenzo, Joel Moss (Autoren)

eBook Download: PDF

2005 | 1. Auflage
320 Seiten
Elsevier Science (Verlag)
978-0-08-045420-7 (ISBN)

Infos

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

Inhalt

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

Produkt-Details

• Erscheint lt. Verlag: 8.9.2005
• Sprache: englisch
• Themenwelt: Schulbuch / Wörterbuch ► Lexikon / Chroniken
• Themenwelt: Medizin / Pharmazie ► Allgemeines / Lexika
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete
• Themenwelt: Medizin / Pharmazie ► Studium
• Themenwelt: Naturwissenschaften ► Biologie
• Themenwelt: Technik
• ISBN-10: 0-08-045420-8 / 0080454208
• ISBN-13: 978-0-08-045420-7 / 9780080454207