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Incompetent Persons as Research Subjects and the Ethics of Minimal Risk

Published online by Cambridge University Press:  29 July 2009

Kathleen Cranley Glass  and
Marc Speyer-Ofenberg
Kathleen Cranley Glass
Affiliation:
Assistant Professor in the Department of Human Genetics, McGill University, Montréal and an Associate Member at the McGill Centre for Medicine, Ethics, and Law, where she collaborates with the Clinical Trials Research Group.
Marc Speyer-Ofenberg
Affiliation:
A doctoral student in the Department of Science and Technology Studies, Cornell University, Ithaca, New York, and a Research Assistant at the Centre for Medicine, Ethics, and Law, McGill University, Montréal, Canada.
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Extract

The voluntary and informed consent of subjects has been the central focus of concern in research reviews, overshadowing the importance of all other considerations. The Nuremberg Code, with its rights-based protection of the subject's autonomy above all else, made it difficult to justify research with no intended benefit when subjects are incompetent to make a valid informed choice to participate. Subsequent codes providing for research with incompetent subjects followed the lead of Nuremberg, substituting the informed authorization of a proxy for the informed consent of the subject.

Type
Special Section: Rejuvenating Research Ethics
Information
Cambridge Quarterly of Healthcare Ethics , Volume 5 , Issue 3 , Summer 1996 , pp. 362 - 372
Copyright
Copyright © Cambridge University Press 1996

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References

Notes

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