THE THERAPEUTIC MISCONCEPTION - INFORMED CONSENT IN PSYCHIATRIC RESEARCH
THE THERAPEUTIC MISCONCEPTION - INFORMED CONSENT IN PSYCHIATRIC RESEARCH
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DOI：
10.1016/0160-2527(82)90026-7
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发表时间：
1982-01-01
影响因子：
2.3
通讯作者：
LIDZ, C
中科院分区：
文献类型：
--
作者：
APPELBAUM, PS;ROTH, LH;LIDZ, C
知情同意已成为医学和精神病学研究的一个被接受的部分，这一过程反映在关于这一主题的大量专业文献的演变中。早期的论文，集中在道德上不适当的研究的存在，很快让位于讨论知情同意作为满足道德要求和保护研究对象的工具。2接下来，研究人员自己也表达了对知情同意对研究进行的影响的担忧。[3]与此同时，随着联邦法规将知情同意牢固确立为人类受试者研究的一个组成部分，大量的实证研究开始出现。有些人打后卫行动，挑战的适用性的原则，理由是受试者不能理解或利用信息的研究人员现在被迫披露; 4其他人调查了各种方法，以提高受试者的理解。[5]在这一过程中，人们对它的关注度相对较低，这一点很明显，因为它详细考虑了向潜在的研究对象披露的实际材料。接受知情同意的伦理和法律的重要性，必须传达哪些信息才能实现预期目标？许多关于这个问题的作者引用了美国卫生与公众服务部法规中列举的条款，这些条款管理着美国大多数人类受试者的研究，好像它们为这个问题提供了一个令人满意的答案。然而，要求未来的主题是亲-
The process by which informed consent has become an accepted part of medical and psychiatric research is reflected in the evolution of the voluminous professional literature on the subject. Early papers, focusing on the existence of ethically improper research,’soon gave way to discussions of informed consent as a tool for satisfying ethical imperatives and protecting research subjects. 2 Researchers themselves weighed in next with concerns about the impact of informed consent on the conduct of research. 3 At the same time, as federal regulations firmly established informed consent as an integral part of research with human subjects, a plethora of empirical studies began to appear. Some fought a rear guard action, challenging the applicability of the doctrine on the grounds that subjects could not comprehend or utilize the information researchers were now obliged to disclose; 4 others investigated a variety of approaches for improving subject comprehension. 5Conspicuous by the relative inattention it received in this process was a detailed consideration of the actual material to be disclosed to prospective research subjects. Accepting the ethical and legal importance of informed consent, what information must be communicated to achieve the desired ends? Many writers on the subject cite the items enumerated in the regulations of the US Department of Health and Human Services, which govern most research with human subjects in the United States, as if they provide a satisfactory answer to this question. Yet, the requirement that prospective subjects be pro-