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Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011 Key PointsQuestionHow often is the study purpose explained to potential participants in randomized clinical trials of antibiotics? FindingsIn this cross-sectional analysis of trial documents submitted to regulators, no informed consent forms consistently conveyed the primary hypothesis of the study. MeaningPatients enrolling in antibiotic clinical trials are not accurately informed of study purpose, raising fundamental questions of the ethics of consent in antibiotic drug trials. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011

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Publisher
American Medical Association
Copyright
Copyright 2017 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2017.3820
pmid
28828473
Publisher site
See Article on Publisher Site

Abstract

Key PointsQuestionHow often is the study purpose explained to potential participants in randomized clinical trials of antibiotics? FindingsIn this cross-sectional analysis of trial documents submitted to regulators, no informed consent forms consistently conveyed the primary hypothesis of the study. MeaningPatients enrolling in antibiotic clinical trials are not accurately informed of study purpose, raising fundamental questions of the ethics of consent in antibiotic drug trials.

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Oct 21, 2017

References