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Death of a Healthy Volunteer in a Human Research Project: Implications for Australian Clinical Research

journal contribution
posted on 2023-05-16, 11:30 authored by Day, RO, Donald ChalmersDonald Chalmers, Williams, KM, Campbell, TJ
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.

History

Publication title

Medical Journal of Australia

Volume

168

Issue

9

Pagination

449-451

ISSN

0025-729X

Department/School

Faculty of Law

Publisher

Australasian Medical Publishing Company Ltd

Place of publication

Sydney

Repository Status

  • Restricted

Socio-economic Objectives

Expanding knowledge in human society

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