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The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations

In an attempt to broaden the current debate over proposed revisions to the Declaration of Helsinki, we define vulnerable subjects as those lacking basic rights, and examine the ethical risks inherent in research on such subjects. We then propose special ethical criteria for the conduct and publication of research on vulnerable subjects.

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This paper was developed from an address entitled “Issues Raised by the Helsinki Declaration” by B.L. at a symposium held to review proposals for change to the Helsinki Declaration (Melbourne, Australia, 30 August 1999). The authors acknowledge the discussion of these issues at a meeting held to prepare for the Melbourne Symposium on the Declaration of Helsinki; participants included J. Oakley (Director, Centre for Human Bioethics, Monash University), J. Black (National Health and Medical Research Council Scholar, Dept. of Epidemiology and Preventive Medicine, Monash University), I. Kerridge (Director, Clinical Unit in Ethics and Health Law, University of Newcastle) and H. McKelvie (Manager, Program Development, Victorian Institute of Forensic Medicine).

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Zion, D., Gillam, L. & Loff, B. The Declaration of Helsinki, CIOMS and the ethics of research on vulnerable populations. Nat Med 6, 615–617 (2000).

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