Clinical research and the law / Patricia M. Tereskerz ; consulting clinical editors, Robert Edelman, Ross McKinney, Jr.

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Year of Publication:2012
Language:English
Online Access:
Physical Description:x, 270 p.
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Table of Contents:
  • Research malpractice & negligence
  • Duty of care : understanding the legal differences between medical treatment and medical research
  • Establishing standard of care & violation of standard of care
  • Informed consent in clinical research
  • Liability issues for institutional review boards (IRBs) and data safety monitoring boards (DSMBs)
  • Legal aspects of financial conflicts of interest in clinical trials
  • Disclosure of clinical trial information : legal ramifications of withholding study results
  • Clinical trials & insider trading
  • Clinical trials and criminal law
  • Clinical trial contracts.