临床试验的伦理审查:精神障碍

Ethic review in clinical research: cognitively impaired persons

精神障碍可能影响患者理解知情告知信息的能力,并可能影响他们做出参加临床研究理性决定的能力。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。

Mental disorders may compromise sufferers＇ capacity to understand the information presented and their ability to make a reasoned decision about participating in clinical research. 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.