The death of a healthy volunteer in a human research project: implications for Australian clinical research.
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.
Day
R O
RO
Clinical Pharmacology, St Vincent's Hospital, Sydney, NSW. R.Day@unsw.edu.au
Chalmers
D R
DR
Williams
K M
KM
Campbell
T J
TJ
D000328:Adult; D000779:Anesthetics, Local / Q000009:adverse effects*; D001315:Australia; D001999:Bronchoscopy; D002985:Clinical Protocols / Q000592:standards*; D032802:Committee Membership; D032962:Consent Forms; D026724:Ethical Review; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D017809:Fatal Outcome; D005260:Female; D033161:Government Regulation; D006801:Humans; D007258:Informed Consent; D008012:Lidocaine / Q000009:adverse effects*; D009518:New York; D035842:Research Subjects; D035844:Researcher-Subject Relations; D014838:Volunteers
D000779:Anesthetics, Local; D008012:Lidocaine