Informed consent: time for more transparency.
Informed consent is not only for documenting a patient's acceptance of enrolling in a clinical trial. It currently is the patient's and, we propose, should also be the public's main source of information regarding the reasons for the planned study, what is known in the field about the proposed trial, and what to expect as far as efficacy and harm. Informed consent is not currently part of the clinical trial registries. For purposes of full disclosure to the patients and the public, the informed consent should be part of the required documents for such registries.
New York University School of Medicine, NYU Hospital for Joint Diseases, 246 East 20th Street, New York, NY 10003, USA. yusuf.yazici@nyumc.org
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D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards*; D032962:Consent Forms / Q000941:ethics / Q000592:standards*; D030881:Disclosure; D006801:Humans; D012042:Registries; D035842:Research Subjects; D014944:World Health Organization