Clinical Research and the Law
eBook - ePub

Clinical Research and the Law

  1. English
  2. ePUB (mobile friendly)
  3. Available on iOS & Android
eBook - ePub

Clinical Research and the Law

About this book

CLINICAL RESEARCH AND THE LAW

The legal implications of conducting clinical research and trials are becoming more complex. Everyone involved in clinical research increasingly needs to be aware of not only the ethical issues at stake but also how the law affects medical practice and research. Much of clinical research and trial law and litigation is comparatively recent and researchers need to ensure current compliance on a wide range of issues including:

  • standards and duty of care
  • conflicts of interest
  • establishing clinical trials
  • informed consent
  • research contracts
  • the disclosure and withholding of clinical trial results

Clinical Research and the Law comprehensively discusses these topics and provides the answers to the legal questions and potential pitfalls encountered in medical research. It is an up-to-date, practical guide for clinical investigators and their institutional administrators, particularly risk managers and research administrators, as well as healthcare administrators and members of institutional review boards.

This book is also a key resource for medical students, postgraduate research students, practicing attorneys and counselors for teaching hospitals and institutions undertaking clinical research and contract research organizations.

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Yes, you can access Clinical Research and the Law by Patricia M. Tereskerz in PDF and/or ePUB format, as well as other popular books in Medicine & Ethics in Medicine. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Wiley-Blackwell
Year
2012
Print ISBN
9781405195676
eBook ISBN
9781118272169
Edition
1
Topic
Medicine
Subtopic
Ethics in Medicine

Table of contents

  1. Cover
  2. Title page
  3. Copyright page
  4. Preface
  5. Chapter 1 Research malpractice and negligence
  6. Chapter 2 Duty of care: understanding the legal differences between medical treatment and medical research
  7. Chapter 3 Establishing standard of care and violation of standard of care
  8. Chapter 4 Informed consent in clinical research
  9. Chapter 5 Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs)
  10. Chapter 6 Legal aspects of financial conflicts of interest in clinical trials
  11. Chapter 7 Disclosure of clinical trial information: legal ramifications of withholding study results
  12. Chapter 8 Clinical trials and insider trading
  13. Chapter 9 Clinical trials and criminal law
  14. Chapter 10 Clinical trial contracts
  15. Appendix A: Glossary of common terms used in connection with clinical trials
  16. Appendix B: Research involving human subjects
  17. Appendix C: Best pharmaceuticals for Children Act
  18. Appendix D: Pediatric research Equity Act of 2003
  19. Appendix E: Title 21–food and drugs: additional safeguards for children in clinical investigations
  20. Appendix F: Proposed standardized/ harmonized clauses for clinical trial agreements
  21. Appendix G: Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors
  22. Index