Regarding clinical research involving individuals who by reason of mental disorders are not capable of giving adequately informed consent , institutional review board should ensure that , such persons will not be subjects of research that might equally well be carried out on persons whose capacity to give adequately informed consent is not impaired ; the purpose of the research is to obtain knowledge relevant to the particular health needs of persons with mental disorders ; the consent of each subject has been obtained to the extent of that person ' s capabilities , and a prospective subject ' s refusal to participate in research is always respected , unless , in exceptional circumstances , there is no reasonable medical alternative and local law permits overriding the objection ; and , in cases where prospective subjects lack capacity to consent , permission is obtained from a legally authorized representative in accordance with applicable law 对于涉及因精神障碍而不能给予充分知情同意受试者的临床研究，伦理委员会应该确保：在给予充分知情同意能力没有受损的人身上能同样好地进行研究，这类人就不能成为受试者；研究的目的是为获得有关精神障碍者特有的健康需要的知识；已获得与每位受试者能力程度相应的同意，可能的受试对象拒绝参加研究应始终受到尊重，除非在特殊情况下，没有合理的医疗替代方法，并且当地法律允许不考虑拒绝；如果可能的受试对象没有能力同意，应获得其法定代理人的许可。
