Ethics of Research without Informed Consent

Dave W. Lu*, Jonathan Burstein, John Jesus

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingChapter


US federal regulations commonly referred to as the Final Rule permit certain emergency and critical care research involving human subjects to take place without obtaining prospective informed consent. Since its passage in 1996, there remains significant controversy over the proper application of the Final Rule in clinical trials seeking an exception from informed consent. This chapter provides a brief review of the history and provisions of the Final Rule, followed by a discussion of the ethical considerations of conducting human subjects research without obtaining prospective informed consent. Remaining ethical challenges to the Final Rule are examined, and recommendations for its future implementation are proposed.

Original languageEnglish (US)
Title of host publicationEthical Problems in Emergency Medicine
Subtitle of host publicationA Discussion-Based Review
PublisherJohn Wiley and Sons
Number of pages10
ISBN (Print)9780470673478
StatePublished - Jun 20 2012


  • Clinical trials
  • Emergency medicine
  • Emergency research
  • Exception from informed consent
  • Informed consent
  • Medical ethics
  • Research ethics
  • Research regulation
  • Resuscitation research
  • Waiver of informed consent

ASJC Scopus subject areas

  • General Medicine


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