Writing Clinical Research Protocols book cover

Writing Clinical Research Protocols

Ethical Considerations

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. It 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 will be 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.

Audience
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.

Paperback, 320 Pages

Published: August 2005

Imprint: Academic Press

ISBN: 978-0-12-210751-1

Reviews

  • "This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is today’s reality, and this book gives real insight into why and how." - JAMA (February 2006)

Contents

  • Section 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
    4. Section II. Preparing the Protocol

    5. Designing a Clinical Research Study
    6. Selecting Subjects for Clinical Studies
    7. Risks and Benefits in Clinical Research
    8. Recruiting Subjects
    9. Informed Consent
    10. Privacy and Control
    11. The "Ethics" Section
    12. Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping

    13. Procedures and Methods
    14. Statistics, Data Collection and Management, and Record Keeping
    15. Section IV. Special Issues

    16. Use of Human Biological Materials
    17. Special Issues Raised by Evolving Areas of Clinical Research
    18. Case Histories: Learning From Experience

    Appendix: Web Resources

    References

    Glossary

    Index

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