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Open Access Commentary

Legal liabilities in research: early lessons from North America

Randi Zlotnik Shaul1*, Shelley Birenbaum2 and Megan Evans3

Author Affiliations

1 Bioethics Department, The Hospital for Sick Children, The University of Toronto Joint Centre for Bioethics, Toronto, Canada

2 Shelley R. Birenbaum Barrister & Solicitor, Toronto, Canada

3 Cassels Brock & Blackwell LLP, Toronto, Canada

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BMC Medical Ethics 2005, 6:4  doi:10.1186/1472-6939-6-4

Published: 13 June 2005

Abstract

The legal risks associated with health research involving human subjects have been highlighted recently by a number of lawsuits launched against those involved in conducting and evaluating the research. Some of these cases have been fully addressed by the legal system, resulting in judgments that provide some guidance. The vast majority of cases have either settled before going to trial, or have not yet been addressed by the courts, leaving us to wonder what might have been and what guidance future cases may bring. What is striking about the lawsuits that have been commenced is the broad range of individuals/institutions that are named as defendants and the broad range of allegations that are made. The research community should take this early experience as a warning and should reflect carefully on practices where research involving human subjects is concerned.