Hayashi S, Suehisa E, Asari S, Maeda I, Nishi I, Iwatani Y, Kanakura Y
Laboratory for Clinical Investigation, Osaka University Hospital, Suita 565-0871.
Rinsho Byori. 2001 Mar;49(3):273-7.
The remaining portion of a laboratory specimen is usually used for education, research, and quality control of laboratory tests in hospitals, but informed consent has not been obtained because of the high volume of patients who undergo laboratory tests. However, patients must be informed in some manner. Therefore, we decided to inform patients that any remaining specimen would be used for various purposes by placing such a notice on walls in the central clinical laboratory and hospital lobby. We then obtained a signature on a dissent document, instead of a consent document, from any patient who dissented from such use. This indirect process for obtaining informed consent was approved by the ethics committee of Osaka University Medical School. The number of dissent documents sent in to the director was 54 of about 400,000 patients who underwent laboratory tests over the last 3 years, and there was no complaint against this "informed consent process".
实验室标本的剩余部分通常用于医院的教学、研究以及实验室检测的质量控制，但由于接受实验室检测的患者数量众多，并未获得知情同意。然而，必须以某种方式告知患者。因此，我们决定通过在中央临床实验室和医院大厅的墙上张贴通知，告知患者任何剩余标本将用于各种目的。然后，对于任何不同意这种用途的患者，我们让其在一份反对文件而非同意文件上签字。这种获取知情同意的间接程序得到了大阪大学医学院伦理委员会的批准。在过去三年接受实验室检测的约40万名患者中，提交给主任的反对文件数量为54份，并且对于这种“知情同意程序”没有任何投诉。
