Clinical Trials Without Consent?

Abstract:

:Fifty years after Beecher's landmark article, an old question is being debated anew: is it ethical to conduct clinical research without consent? This paper provides a systematic analysis of this question. First, it describes five clinical trials that have either been conducted (or proposed) without the subjects providing consent. Second, it reviews a number of conditions that are often provided to justify bypassing of consent and finds that only some of them qualify as necessary conditions for bypassing consent. When those conditions are applied to the clinical trials, only one trial without consent (a type of cluster randomized trial) appears clearly justified; bypassing consent in the remaining four trials is more questionable. The present analysis may be useful in the interpretation of the current U.S. regulations that provide for waivers and alterations of informed consent.

journal_name

Perspect Biol Med

authors

Kim SY

doi

10.1353/pbm.2016.0023

subject

Has Abstract

pub_date

2016-01-01 00:00:00

pages

132-46

issue

1

eissn

0031-5982

issn

1529-8795

pii

S1529879516100109

journal_volume

59

pub_type

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