知情同意的若干問題

Several Questions About Informed Consent

Abstract

LANGUAGE NOTE | Document text in Chinese; abstract also in English.

作為一種法律學說，知情同意在西方社會已經存在多年，並且得到長足的發展。這一學說來源於《紐倫堡法典》。知情同意不僅僅是“法律文件”，也不是醫患“共同決策"，它是具有豐當倫理內涵的一個概念，是一個人實際理解並且真正在沒有他人控制下有意地批准和同意專業人員做某事。

中國具有其獨特的文化傳統背景和經濟發展水平，西方國家基於自主的和權利的理論、信念以及方法在中國基於義務的和強調集體的傳統文化中尚缺乏一定的根基。中國文化傳統上的倫理決策是基於義務而不是基於權�的。這種根深蒂岡的傳統所肯定的是社會或者整體的利益，容易忽視的是個人應享有的權利。在中國文化傳統中，家庭和社區具有很強的凝聚力，家庭或社區協助和支持下的知情同意往往建立在更加充分的理解、思考基礎之上。這種知情同意獲得的方式很有價值：更加精緻，更加體現了尊重人的倫理學原則。但是需要注意的是，這種協助不能完全超越自我決定性。另外，社區的“允許”並不等同於個人的“同意”，而且社區的允許也不應該取代個人的同意。

另外，目前在中國，臨床藥理試驗，倫理審查委員會（IRBs）制度化，合理的補償與不正當的引誘的區別，基因研究中的知情同意問題以及利益衝突等很多現實問題都需要引起倫理學的關注，並進行大量的研究工作。

In Western societies, the idea of informed consent as a legal account has long been there and developed significantly. This idea originated from the "uremberg Code". In fact, informed consent is neither a mere "legal document" nor a "common decision" made by the physician and the patient. It is a concept rich in moral content. It is about how an individual perceives and intentionally (without being controlled by others) agrees and allows professionals to carry out certain actions on him/her.

China has a unique traditional cultural background and economic development level. Due to the emphasis on responsibility and collectiveness in Chinese cultural traditions, introducing the Western theory, beliefs, and practice based upon individual autonomy and rights to Chinese society does not have solid foundation. According to Chinese cultural traditions, people consider responsibility instead of rights during making ethical decisions. These deeply-rooted traditions assure the interests of the whole and tend to neglect the rights of the individual. Chinese families and communities have a very strong sense of cohesiveness. With the assistance and support of the family or community, the thinking and understanding of informed consent can be established on a more adequate and solid foundation. This kind of way to get informed consent is very valuable: it is more accurate and can also fulfills the ethical principle of respect. However, the assistance of the family or community should not override individual's autonomy in making decisions. Moreover, community "permission" is not equal to individual "consent". Indeed, it should not replace individual "consent".

Contemporary China faces many practical problems, such as clinical medicine testing, establishing Institutional Review Broads (IRBs), differences between reasonable compensation and improper reward, conflict of interests in genetic research as well as the practice of informed consent. They demand ethical attention and a large amount of careful research.

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