Informed consent in medical research – a procedure stretched beyond breaking point?

Søren Holm and Søren Madsen

in The Limits of Consent

Published in print January 2009 | ISBN: 9780199231461
Published online September 2009 | e-ISBN: 9780191723858 | DOI:
 Informed consent in medical research – a procedure stretched beyond breaking point?

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This chapter considers the question of whether the institutionalized and formalized practice of informed consent in the context of clinical research has been stretched beyond breaking point. It focuses on the kinds of research where the potential participants are patients (i.e., not healthy volunteers) and where they have some important health interest at stake, usually because they have a serious illness and the research project is a trial of a new therapy. This kind of research includes the standard, double blind, randomized trial, as well as a range of other trial designs. The chapter begins with a brief account of the concept of informed consent and of its possible philosophical justifications. It then analyzes what is known about the way in which potential trial participants make their decisions concerning whether or not to participate and considers the implications of this knowledge for informed consent. Finally, the chapter provides a more theoretical discussion of whether informed consent is the right kind of transfer mechanism for rights to control health information or tissue samples.

Keywords: medical studies; clinical research; randomized trials; patient decision-making; trial participants; health information; tissue samples

Chapter.  6749 words.  Illustrated.

Subjects: Public Health and Epidemiology

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