New York University School of Medicine, NYU Hospital for Joint Diseases, 246 East 20th Street, New York, NY 10003, USA.
Arthritis Res Ther. 2010;12(3):121. doi: 10.1186/ar3004. Epub 2010 Jun 3.
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.
知情同意不仅是为了记录患者对参加临床试验的接受程度。它目前是患者的，而且我们提议，也应该是公众了解研究计划原因、该试验领域内已知情况以及预期疗效和危害的主要信息来源。知情同意目前不是临床试验注册的一部分。为了向患者和公众充分披露信息，知情同意应该成为这些注册所需文件的一部分。
