Báo cáo y học: "Informed consent: time for more transparency"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học General Psychiatry cung cấp cho các bạn kiến thức về ngành y đề tài: Informed consent: time for more transparency. | Yazici and Yazici Arthritis Research Therapy 2010 12 121 http content 12 3 121 COMMENTARY L__ Informed consent time for more transparency Yusuf Yazici 1 and Hasan Yazici2 Abstract 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. The World Health Organization has developed a single international standard for the information that authors of clinical trials must disclose 1 . The informed consent form original or subsequent versions if the trial protocol necessitates is not among the listed items. More recent schemes to expand registration of clinical trials also do not include full disclosure of informed consent forms 2 3 . We strongly feel that the exclusion of informed consent is a serious omission in our current attempt to make clinical trials more transparent we give four specific reasons in support of this view 1. The patients and the public should know whether the study involves a medication that has already been shown to be effective in other similar studies. Informed consent forms are supposed to include this information to help patients make an informed decision about the possible benefit they may get from participating in the trial. Although all clinical trials should ideally be conducted with the goal of improving medical knowledge other reasons for clinical trials including simple promotion are seen 4 . There is little scientific or societal gain in repeating clinical trials with medications that have already shown .

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