Clinical Research and the Law


Journal Article

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. © 2012 Patricia M. Tereskerz.

Full Text

Duke Authors

Cited Authors

  • Tereskerz, PM; Edelman, R; McKinney, R

Published Date

  • April 24, 2012

Published In

  • Clinical Research and the Law

Digital Object Identifier (DOI)

  • 10.1002/9781118272152

Citation Source

  • Scopus