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临床研究的同意——是充分自愿还是受到实质性影响?

Consent to clinical research--adequately voluntary or substantially influenced?

作者信息

Hewlett S

机构信息

University of Bristol.

出版信息

J Med Ethics. 1996 Aug;22(4):232-7. doi: 10.1136/jme.22.4.232.

Abstract

In clinical research the giving of consent by the patient often lies within the context of illness or the doctor/patient relationship. On exploration of these issues it would appear unlikely that the patient's consent is free of substantial influences, some of which may be strong enough to be controlling. Five categories of consent are suggested: voluntary, involuntary, coerced, enforced and partially voluntary. It is argued that consent in clinical research is substantially influenced and thus only partially voluntary. Several practical strategies are proposed to ensure adequately voluntary consent by reducing some circumstantial influences when consent to clinical research is obtained.

摘要

在临床研究中,患者给予同意往往处于患病背景或医患关系之中。对这些问题进行探究后发现,患者的同意似乎不太可能不受实质性影响,其中一些影响可能强大到足以起到控制作用。文中提出了五类同意:自愿、非自愿、被迫、强制和部分自愿。有人认为,临床研究中的同意受到了实质性影响,因此只是部分自愿。文中还提出了几种切实可行的策略,以便在获取临床研究同意时,通过减少一些环境因素的影响来确保充分的自愿同意。

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