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[精神病学中的知情同意——欧洲标准及差异、问题与建议]

[Informed consent in psychiatry--European standards and differences, problems and recommendations].

作者信息

Helmchen H

机构信息

Psychiatrische Klinik und Poliklinik der Freien Universität Berlin.

出版信息

Fortschr Neurol Psychiatr. 1997 Jan;65(1):23-33. doi: 10.1055/s-2007-996306.

Abstract

Development and state of regulations and ethical debates of "informed consent" in 9 European countries are exposed. Commonalities and differences in significance, evaluation, and use of information, capacity to consent, and voluntariness as prerequisites of a valid consent are discussed with regard to care/dure and research. Consequently recommendations for regulations, research, teaching, and practice of "informed consent" and for research with incapacitated patients are given. The legal doctrine of "informed consent" tries to realize or even to operationalize the ethical demand for respect towards dignity and autonomy of the patient. This is particularly relevant in psychiatry because many states of mental disorders may impair the capacity to consent and the internal as well as external freedom of the patient. Validity, reliability, practicability, and acceptance of criteria and procedures of assessment of capacity to consent and of voluntariness of the patient, substitutes in the case of loss of these prerequisites of "informed consent", and its limitations, e.g. by the other ethical principle of the "best interest" of the patient or by his sociocultural context, are in need to be evaluated empirically in practice.

摘要

本文揭示了9个欧洲国家“知情同意”法规的发展情况及伦理辩论状况。针对护理/治疗和研究,讨论了有效同意的前提条件在信息的重要性、评估和使用、同意能力以及自愿性方面的共性与差异。因此,给出了关于“知情同意”法规、研究、教学和实践以及针对无行为能力患者研究的建议。“知情同意”的法律原则试图实现甚至落实对患者尊严和自主性表示尊重的伦理要求。这在精神病学中尤为重要,因为许多精神障碍状态可能损害患者的同意能力以及其内在和外在的自由。患者同意能力和自愿性评估标准及程序的有效性、可靠性、实用性和可接受性,在“知情同意”这些前提条件缺失时的替代措施,以及其局限性,例如受患者“最大利益”这一其他伦理原则或其社会文化背景的影响,都需要在实践中进行实证评估。

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