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The death of a healthy volunteer in a human research project: implications for Australian clinical research
Author(s) -
Day Richard O,
Williams Kenneth M,
Campbell Terence J,
Chalmers Donald RC
Publication year - 1998
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/j.1326-5377.1998.tb139026.x
Subject(s) - volunteer , human research , clinical research , tragedy (event) , protocol (science) , medicine , research ethics , informed consent , ethics committee , family medicine , psychology , alternative medicine , political science , psychiatry , pathology , public administration , agronomy , biology , cognitive science
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.