| Description |
xix, 300 pages ; 23 cm |
| Contents |
Sect. I. The basics : what you need to know before starting human subjects research -- 1. Introduction to the art and science of clinical research -- 2. What you need to know about clinical research ethics -- 3. What you need to know about the regulation of clinical research -- Sect. II. Preparing the protocol -- 4. Designing a clinical research study -- 5. Selecting subjects for clinical studies -- 6. Risks and benefits in clinical research -- 7. Recruiting subjects -- 8. Informed consent -- 9. Privacy and confidentiality -- 10. The "ethics" section -- Sect. III. Procedures, methods, statistics, data management, and record keeping -- 11. Procedures and methods -- 12. Statistics, data collection and management, and record keeping -- Sect. IV. Special issues -- 13. Use of human biological materials -- 14. Special issues raised by evolving areas of clinical research -- 15. Case histories : learning from experience |
| Summary |
"This book includes a wide range of ethical considerations that need to be addressed in the course of designing and gaining approval for a human research study. The current literature on ethics for clinical researchers is limited. That which exists tends to focus on a particular area of research ethics, such as consent or Institutional Review Boards. This book offers the researcher guidelines on writing protocols from the perspective of the ethical judgments to be made within each section of the protocol and consent documents. Writing Clinical Research Protocols: Ethical Considerations thus fills a conspicuous void in the research literature."--BOOK JACKET |
| Notes |
Formerly CIP. Uk |
| Bibliography |
Includes bibliographical references (pages 273-280) and index |
|
Includes web resources |
| Subject |
Clinical trials.
|
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Research -- Methodology.
|
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Research -- Moral and ethical aspects.
|
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Clinical Protocols.
|
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Ethics.
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Writing.
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Biomedical Research -- ethics.
|
| Author |
Moss, Joel.
|
| LC no. |
00002844 |
| ISBN |
0122107519 (paperback) |
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