Helmchen H
Control Clin Trials. 1981 May;1(4):435-40. doi: 10.1016/0197-2456(81)90049-0.
The author begins by considering what kinds of questions should be used to establish informed consent, and particularly seeks to establish criteria for a valid consent; both for the person who asks the patient for consent, and for the person who judges the consent as a valid one. Then some variables--duration, severity and kind of illness, and type of personality--are considered that may influence consent. With regard to the discrepancy between the law and reality, it is proposed not to interpret the requirements of the law in a sense of all-or-none but as a demand that must be adapted adequately in content and in time to the individual patient and that they should be embedded in the therapeutic process that is an expression of the so-called "therapeutic privilege." Finally, it is asked, what are the consequences of information and consent on the results of therapy as well as of research? The necessity of empirically based research to answer these unsolved questions is emphasized.
作者首先思考了哪些类型的问题可用于确立知情同意，尤其致力于为有效同意确立标准；这既适用于向患者征求同意的人，也适用于判定同意有效的人。接着探讨了一些可能影响同意的变量——疾病的持续时间、严重程度和种类以及人格类型。关于法律与现实之间的差异，提议不要将法律要求理解为非此即彼，而应将其视为必须在内容和时间上充分适应个体患者的要求，并且这些要求应融入治疗过程，这体现了所谓的“治疗特权”。最后，文中提出，信息与同意对治疗结果以及研究结果会产生哪些影响？强调了开展基于实证的研究以回答这些未解决问题的必要性。
