The Death of a Healthy Volunteer in a Human Research Project: Implications for Australian Clinical Research
Day, Richard O.
Chalmers, Donald R.C.
Williams, Kenneth M.
Campbell, Terence J.
Medical Journal of Australia. 1998 May 4; 168(9): 449-451.
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.
Anesthesia; Committee Membership; Consent Forms; Clinical Research; Consent; Death; Ethics; Ethics Committees; Forms; Government; Government Regulation; Guidelines; Health; Human Experimentation; Injuries; Institutional Ethics; Investigator Subject Relationship; Motivation; Medical Research; Regulation; Remuneration; Research; Research Design; Research Ethics; Research Ethics Committees; Review; Risk; Students; Technical Expertise; Toxicity; Volunteers;
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The Death of a Healthy Volunteer in a Human Research Project: Implications for Australian Clinical Research Day, Richard O.; Chalmers, Donald R. C.; Williams, Kenneth M.; Campbell, Terence J. (1998-05-04)