Abstract 摘要

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.