加拿大三大研究理事会政策宣言及对我国多中心伦理审查的启示

Canadian TCPS and the Enlightenment to Chinese Ethical Review of Multi-center Research

1998年,三大研究理事会政策宣言(Tri-Council Policy Statement,TCPS)正式通过,2011年通过了第二版,是加拿大多中心伦理审查领域的重要准则。TCPS通过构建适宜的多中心伦理审查决策框架、注意多中心伦理审查的沟通及透明度、确保充足的资源以支持多中心伦理审查进程以及妥善处理操作层面问题等途径,提高多中心伦理审查的效率与成功率。可以在强化多中心伦理审查立法、注意协调多方关系、确保研究项目的科学性以及对审查人员进行教育培训等方面为我国多中心伦理审查提供借鉴。

In 1998,Tri-Council Policy Statement（TCPS）was formally adopted.In 2011the second edition was passed.It is an important criterion of Canadian multi-center ethical review.TCPS plays an essential role in improving the efficiency and success rate of the multi-center ethical review through the construction of an appropriate decision framework of multicenter ethical review,the attention to the communication and transparency of multi-center ethical review and the assurance of sufficient resources to support the multi-center ethical review process and to properly handle the problems at the operational level.TCPS,which strengthens the legislation of the multi-center ethical review,pays attention to coordinate the relationship between parties and ensures the scientific nature of the research project and the education and training of the staff,can serve as a reference for multi-center ethical review in China.