美国多中心临床试验伦理审查经验对我国的启示——以美国国家癌症研究院为例

Enlightenment of Ethical Review Experience of Multi-Center Clinical Trials in the United States to Our Country:Taking the National Cancer Institute of the United States as an Example

随着生物医学的不断发展,多中心临床合作日益增多,多中心伦理审查成为国际趋势。我国多中心伦理审查起步较晚,理论和实践方面仍存在问题。通过检索美国多中心伦理审查的相关文献,以美国国家癌症研究院为例介绍美国伦理审查的研究经验,并进行本土化研究。提出完善我国多中心临床试验的法律及指南,确立一元制的审查模式,设置不同类型中心伦理委员会,建立组长单位中心审查网站四个方面建议,以逐步完善我国多中心伦理审查工作。

With the development of biomedical science, muhi -center clinical cooperation is increasing, and muhi - center ethical review has become an international trend. China＇ s muhi - center ethical review started late, and there are still problems in the theory and practice. Through the retrieval of relevant literature about muhi - cen- ter ethical review in the United States, taking the National Cancer Institute （NCI） as an example, this paper intro- duced the research experience of American ethical review and carried out localization research. In order to gradual- ly consummate the muhi - center ethical review work of our country, this paper put forward four suggestions of con- summating the laws and guidelines, establishing the examination mode of the centralized leadership system, setting up dirt）rent types of central ethics committee and establishing the unit center review website .