SIDCER、AAHRPP认证和CAP认证的比较研究

Comparative Study of SIDCER Recognition,AAHRPP Accreditation and CAP Accreditation

目前常见的伦理审查认证体系包括:亚太地区伦理审查委员会论坛组织的"伦理审查委员会能力拓展战略方案"(SIDCER认证)、美国人体研究保护体系认证协会的认证(AAHRPP认证)和我国的中医药研究伦理审查体系认证(CAP认证)。通过对这三种体系进行多方面的深入比较,说明SIDCER认证关注的重点是伦理委员会(IRB)的标准操作规程(SOP)规范性,要求实际操作与SOP保持一致;AAHRPP认证强调的是机构、IRB、研究者等共同建立有效的受试者保护体系,其标准主要依据美国法规体系;CAP认证是个新生事物,依据我国现行法规制度建立,也强调建立受试者保护体系,更有利于指导我国一般机构建立伦理审查体系。

There are three common accreditation systems, including Strategic Initiative for Developing Capacity in Ethical Review （SIDCER recognition） launched by Forum for Ethical Review Committees in the Asian ＆ Western Pacific Region, accreditation of Association for the Accreditation of Human Research Protection Program （AAHRPP accreditation） and Assessment Human Research Protection System of Chinese Medicine （CAP accreditation） launched by World Federation of Chinese Medicine Society in China. By comparison of the three systems from many different aspects, this paper illustrated their features as follows： SIDCER emphasized on the conformity of SOP with laws and regulations, as well as its consistency with real practice; AAHRPP called for different parties such as organization, IRB and researchers to work together to build a human research protection system on the basis of U. S. laws and regulation; CAP accreditation was mainly based on Chinese law and oversight system and also emphasized on building a human research protection system , which was more suitable for medical institutions in China.