Aoki S
Seishin Shinkeigaku Zasshi. 1992;94(4):363-7.
I do appreciate the "PRINCIPLES FOR THE PROTECTION OF PERSONS WITH MENTAL ILLNESS AND FOR THE IMPROVEMENT OF MENTAL HEALTH CARE" dated 5 February 1991 submitted by the Commission on Human Rights. To make it even more explicit, however, the following paragraphs should be added to two of the Principles: 1. As for Principle 11. 13, the requirement of informed consent by a personal representative should be prescribed in the case of a major medical or surgical procedure for an incompetent patient, in addition to the approval by an independent review body concerning such therapy, for the sake of consistency with Principle 11. 7 with regard to the right of privacy. 2. As for Principle 11. 15, the following three paragraphs should or may be added which have also been prescribed in "Principles for the Human Experiments" by the Japanese Society of Psychiatry and Neurology (1973), for the sake of consistency with Principle 11.7 with regard to the right of privacy and Principle 11.4 providing for the special protection of an incompetent patient: 2. 1 The requirement of informed consent by his/her personal representative should be prescribed in a case of clinical trials or experimental treatment for an incompetent patient. 2. 2 Intrusive and irreversible clinical trials and experimental treatment should never be carried out on a patient who is an involuntary patient in a mental health facility and they may be carried out on any other patient only where an independent external body has satisfied itself that there is genuine informed consent of the patient. 2. 3 It may be better to add the following paragraph: "clinical trials and experimental treatment shall never be carried out on an incompetent patient which are not necessary for the therapy of his/her disease or which are possible on a normal healthy person or a mentally ill patient having the ability to give informed consent."
我非常赞赏人权委员会于1991年2月5日提交的《保护精神病患者和改善精神保健的原则》。然而,为使其更加明确,应在其中两条原则中添加以下段落:1. 关于原则11.13,对于无行为能力患者的重大医疗或外科手术,除独立审查机构对该治疗的批准外,还应规定由个人代表给予知情同意的要求,以便与关于隐私权的原则11.7保持一致。2. 关于原则11.15,应添加或可添加以下三段内容,日本精神神经学会(1973年)的《人体实验原则》中也有规定,以便与关于隐私权的原则11.7和规定对无行为能力患者进行特殊保护的原则11.4保持一致:2.1对于无行为能力患者的临床试验或实验性治疗,应规定由其个人代表给予知情同意的要求。2.2对于精神卫生机构中的非自愿患者,绝不应进行侵入性和不可逆转的临床试验及实验性治疗,对于任何其他患者,只有在独立的外部机构确信患者已真正给予知情同意的情况下,才可进行此类试验和治疗。2.3最好添加以下段落:“对于无行为能力患者,绝不应进行对其疾病治疗不必要的、在正常健康人或有能力给予知情同意的精神病患者身上也可进行的临床试验和实验性治疗。”