Clinical Trials: Legal Aspects and Consent

  • K. L. Cerminara
  • , R. S. Feinberg

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Clinical trials create both legal and ethical concerns, many of which overlap. This chapter focuses on informed consent of human research subjects, participation of special populations in medical research, medical research involving the mentally incapacitated, the use of placebos in human subject research, confidentiality of subject information, conflicts of interest in clinical trials, and research review committees.

Original languageEnglish
Title of host publicationEncyclopedia of Forensic and Legal Medicine
Subtitle of host publicationSecond Edition
PublisherElsevier Inc.
Pages569-575
Number of pages7
ISBN (Electronic)9780128000557
ISBN (Print)9780128000342
DOIs
StatePublished - Nov 4 2015

Bibliographical note

Publisher Copyright:
© 2016 Elsevier Ltd. All rights reserved.

ASJC Scopus Subject Areas

  • General Social Sciences

Keywords

  • Clinical research
  • Clinical trial
  • Confidentiality
  • Conflict of interest
  • Consent
  • Double blind
  • Human research subjects
  • Informed consent
  • Institutional review board
  • Medical research
  • Mentally incapacitated
  • Placebo
  • Research ethics committee/ethical review committee
  • Vulnerable populations

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