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The Oliveri Case: Lessons for Australasia


Dodds, SM and Downie, J and Thompson, J and Baird, P, The Oliveri Case: Lessons for Australasia, Journal of Bioethical Enquiry, 2, (2) pp. 90-105. ISSN 1176-7529 (2005) [Refereed Article]

DOI: doi:10.1007/BF02448848


The case of Dr. Nancy Olivieri, the Hospital for Sick Children, the University of Toronto, and Apotex Inc. vividly illustrates many of the issues central to contemporary health research and the safety of research participants. First, it exemplifies the financial and health stakes in such research. Second, it shows deficits in the ways in which research is governed. Finally, it was and remains relevant not only in Toronto but in communities across Canada and well beyond its borders because, absent appropriate policies, what happened in Toronto could have happened (and could well still happen) elsewhere. In Part One of this paper, we review the facts of the Olivieri case relevant to the issues we wish to highlight: first, the right of participants in a clinical trial to be informed of a risk that an investigator had identified during the course of the trial and the obligation of the investigator to inform participants (both her own and those of other investigators); and second, the obligation of institutions to protect and promote the well-being of research participants as well as academic freedom and research integrity, the obligations of research sponsors to inform participants, research regulators, and others about unforeseen risks, and the obligations of research regulators to ensure that participants are informed of unforeseen risks and to otherwise protect and promote research integrity. In Part Two, we relate these facts and issues to New Zealand and Australia. We also make detailed recommendations for changes to the various instruments used for the governance of research involving humans in Australasia.

Item Details

Item Type:Refereed Article
Research Division:Philosophy and Religious Studies
Research Group:Applied ethics
Research Field:Bioethics
Objective Division:Expanding Knowledge
Objective Group:Expanding knowledge
Objective Field:Expanding knowledge in philosophy and religious studies
UTAS Author:Dodds, SM (Professor Susan Dodds)
ID Code:58770
Year Published:2005
Deposited By:Philosophy
Deposited On:2009-10-27
Last Modified:2011-10-12

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