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Abstract 摘要

Since its introduction into China as a bioethical principle, informed consent has been a controversial topic. Many doubt its adoptability in the Chinese context. They claim that in China, it is often the family and not the patient that makes the decision about patient care in real clinical practice or medical research. In addition, Chinese culture appears incompatible with the principle of informed consent. As a result, many scholars conclude that Chinese culture constitutes a challenge to the application of informed consent in China.

This essay contends that such an argument does not hold water, or at least, is not well justified. First, such a claim obviously fails to tell everything about the situation in China. In addition, a factual judgment cannot take the place of an ethical one, while an ethical judgment should be made taking a wide perspective. When we seek to determine the justifiability of family consent with certain facts, we need to consider also whether it is conducive to the protection of the rights and benefits of the patient. When people assert that autonomy is not part of Chinese culture, they should not rely on just a factual presentation. Rather, they should go a step further, to work at the meaning and significance of autonomy, so that they can determine whether such a claim is universally true. In fact, Confucian Chinese culture features rich intellectual and moral resources that support individual independence, creativity, and freedom. For example, in the Confucian classics, including the Analects, we can easily find sayings of Confucian sages that emphasize a free, independent, and strong will, which underlies informed consent.

Autonomy, which is the theoretical basis of informed consent, is important because it plays a decisive role in helping to safeguard the rights and benefits of patients. It should be quite clear that it is irrelevant to try to determine whether family consent damages the theory of informed consent, or to try to reconstruct the theoretical framework for informed consent. This essay contends that the key issue to be addressed is to improve the necessary operational measures for implementing informed consent.

知情同意原則自引進中國以來,遭遇到能否與中國文化相適應的質疑。這樣的質疑,基於以下兩個事實判斷:一是,在現實的臨床和研究的同意過程中,往往是家庭共同參與或代替病人或研究參與者決策,而不是由他們本人單獨作決定;二是,從文化傳統來看,中國文化似乎不具備知情同意的理論基礎。由此,一些學者認為中國文化對知情同意形成了挑戰。本文認為,這兩個事實判斷不足以證明中國文化對知情同意構成了挑戰。這不僅因為這樣的事實不是全部的、或真正的事實,而且還因為事實判斷不能代替倫理判斷。倫理的判斷需要更為廣泛的視角。當我們試圖以一些事實說明家庭同意是合理的,那麼我們須要考察,家庭同意是否保護了病人和受試者的利益和權利?當我們斷言說中國文化缺乏自主性的特質時,除了事實的說明外,還須要對自主性的內涵及其意義作出分析,從而能夠判斷這樣的結論是否具有普遍性。自主性之所以是重要的,並成為知情同意的理論基礎,是因為借此病人和受試者可按照自己的利益、意願來行動、決定和選擇,從而達到保護他們的目的。從這個意義上說,沒有必要去深究家庭同意是否撼動了知情同意的基礎,或重新構建知情同意的理論基礎。知情同意的文化敏感性更應該著眼於操作層面。

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