《赫爾辛基宣言》縱橫談

On the Declaration of Helsinki and Its Implications for China

Abstract

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

自從20世紀80年代末，隨著中國和其他國家在生物醫學科研上合作的增多，與之有關的倫理問題隨之增加。尤其是20世紀以來，如果說科研倫理學是生命倫理學領域的一顆新星不過分的話，那麼，赫爾辛基宣言就是科研倫理學的核心的說法是很恰當的。為了提高科研倫理學的意識，保護受試者的權益，預防潛在的倫理問題的發生，順著赫爾辛基宣言發展的歷史並找尋其中變遷的線索是非常必要的。具體來說，從紐倫堡法典產生的背景和內容開始，追溯1964、1975、1983、1989、1996、2000和2002年赫爾辛基宣言變化的原因，並把主要變化的內容單獨注出來，以利於讀者進行比較分析。探詢歷史發展的軌跡，是為了從中吸取經驗教訓，完善對受試者保護權益保護的機制。本文所有的材料都是為了這個目的服務的。關於國際前沿性的對最新的赫爾辛基宣言的爭論，讀者頭腦中要有各國對科研倫理學原則的多元化的理解這樣一個概念，同時要知道聲音最大的背後的原因，而且更重要的是要有結合中國實際情況的意識，以及是否適合中國的情況的分析，否則仍要停留在被動盲從的地位，不能真正實現科研倫理學應有的實踐性價值。

Along with the development of biomedical research cooperation between China and other countries since late 1980s, many ethical issues have occurred. It is not exaggerating to claim that research ethics is a bright star in the field of bioethics, especially since the end of the 20th-century. It is also appropriate to say that the Declaration of Helsinki consists of the core of contemporary research ethics. This paper will trace the history of Declaration of Helsinki and seek for the clue for positive changes. To do so should be able to help to raise the consciousness of research ethics in people, to protect the rights and welfare of human subjects, and to prevent some potential ethical problems from happening.

This article will describe in detail on the background from the Nuremberg Code to the Declaration of Helsinki and on changes happened in different versions of the Declaration of Helsinki in 1964, 1975, 1983, 1989, 1996, 2000 and 2002. The obvious and significant changes of different versions will be highlighted for the convenience of the reader. The aim of this historical review is to learn the experiences and related lessons in the West and thus to develop the system of human subject protection in China. All the materials of the article are directed to this aim. Regarding the current ethical debates on the latest version of the Declaration of Helsinki, we should be aware of the moral pluralism and plurality among different countries. It is important to analyze and understand the strongest voice in the debate and the background of this voice.

Yet, the most challenging task is to find out what is suitable for our country- China- - and what is not. In other words, while we need to learn from the West about human subject protection such as the historic and influential document like the Declaration of the Helsinki, it is crucial to root Chinese research ethics in our particular conditions in China. Otherwise, we will always in the status of simply following the West blindly and cannot fulfill the practical significance of research ethics in Chinese reality.

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