美国受试者保护体系及其启示——以杜克大学为例

Introduction and Enlightenment of the Human Subject Protection Program in U. S

作为目前世界上受试者保护体系建设和法规建制最为完善的国家之一，美国受试者保护体系的建设对中国受试者保护制度的建立和完善具有重要的现实指导意义。本文在简要介绍美国受试者保护制度发展以及法规框架的基础上，以杜克大学为例介绍了美国机构层面的受试者保护体系架构，并结合北京大学受试者保护体系建设的现状与挑战进行探讨。

As human subject protection become more and more significant in China, it＇s imperative for China to learn more experiences from U. S for which developed a normative and well designed HRPP system during past decades. In this article, we gave a brief introduction of the Human Subject Protection Program at Duke University to help us have a better understanding of the HRPP at institutional level. After which we have further discussion of the status quo and challenges facing in HRPP construction in China, especially, Peking University as an example.