Clinical Research and the Law

Author: Patricia M. Tereskerz  

Publisher: John Wiley & Sons Inc‎

Publication year: 2012

E-ISBN: 9781118272183

P-ISBN(Paperback): 9781405195676

P-ISBN(Hardback):  9781405195676

Subject: R-0 General Theory

Language: ENG

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Description

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
  • informed consent
  • conflicts of interest
  • research contracts
  • establishing clinical trials
  • 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.

Chapter

Contents

pp.:  1 – 7

Preface

pp.:  7 – 11

Chapter 3: Establishing standard of care and violation of standard of care

pp.:  35 – 45

Chapter 4: Informed consent in clinical research

pp.:  45 – 49

Chapter 5: Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs)

pp.:  49 – 67

Chapter 6: Legal aspects of financial conflicts of interest in clinical trials

pp.:  67 – 77

Chapter 7: Disclosure of clinical trial information: legal ramifications of withholding study results

pp.:  77 – 99

Chapter 8: Clinical trials and insider trading

pp.:  99 – 117

Chapter 9: Clinical trials and criminal law

pp.:  117 – 129

Chapter 10: Clinical trial contracts

pp.:  129 – 157

Appendix A: Glossary of common terms used in connection with clinical trials

pp.:  157 – 163

Appendix B: Research involving human subjects

pp.:  163 – 175

Appendix C: Best pharmaceuticals for Children Act

pp.:  175 – 185

Appendix D: Pediatric research Equity Act of 2003

pp.:  185 – 205

Appendix E: Title 21–food and drugs: additional safeguards for children in clinical investigations

pp.:  205 – 215

Appendix F: Proposed standardized/harmonized clauses for clinical trial agreements

pp.:  215 – 221

Appendix G: Responsibility of applicants for promoting objectivity in research for which public health service funding is sought and responsible prospective contractors

pp.:  221 – 237

Index

pp.:  237 – 269

LastPages

pp.:  269 – 282

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