The death of a healthy volunteer in a human research project: implications for Australian clinical research

Med J Aust. 1998 May 4;168(9):449-51. doi: 10.5694/j.1326-5377.1998.tb139026.x.

Abstract

A healthy 19-year-old United States college student volunteer in a clinical research program underwent a bronchoscopy and died as a result of acute lignocaine toxicity. The major contributing factor in the tragedy was that the research protocol failed to specify an upper dose limit for lignocaine spray, although previous versions of the protocol had done so. We look at the implications of this case for Australian institutional ethics committees.

Publication types

  • Case Reports

MeSH terms

  • Adult
  • Anesthetics, Local / adverse effects*
  • Australia
  • Bronchoscopy*
  • Clinical Protocols / standards*
  • Committee Membership
  • Consent Forms
  • Ethical Review*
  • Ethics Committees, Research*
  • Ethics, Medical
  • Fatal Outcome
  • Female
  • Government Regulation
  • Humans
  • Informed Consent
  • Lidocaine / adverse effects*
  • New York
  • Research Subjects
  • Researcher-Subject Relations
  • Volunteers*

Substances

  • Anesthetics, Local
  • Lidocaine