訾明杰,唐旭东,高蕊,Tim Z.Shi.中美两国对国际人体受试者保护体系认证的认知差异[J].中国中西医结合杂志,2012,32(8):1117-1120 |
中美两国对国际人体受试者保护体系认证的认知差异 |
The Difference in Acknowledging the AAHRPP between China and America |
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DOI: |
中文关键词: 认知 国际人体受试者保护体系 |
英文关键词:acknowledgement Association for the Accreditation of Human Research Protection Program |
基金项目:国家“重大新药创制”创新药物研究开发技术平台建设(No.2012ZX09303010-002) |
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中文摘要: |
在国家鼓励创新药研发的积极势态下,国内各临床试验机构更加重视提高人体医学研究过程中对受试者的保护,并积极遵循医学伦理实践的规范。只有从国际人体受试者保护体系认证整体及各个认证领域不同层面深入分析,清楚了解中美两国医院对国际人体受试者保护体系认证的认知差异,才能有的放矢,做好争取国际相关组织认证的准备工作。 |
英文摘要: |
With the active encouragement of the Chinese government,all domestic clinical research institutes pay more attention to the human research protect program(HRPP) during the process of clinical trials,and actively follow the regulations of medical ethical practice.We could make fully preparation for the accreditation by the correlated international organizations only by further analyzing the Association for Accreditation of Human Research Protection Program(AAHRPP) from a whole and in each accreditation field at different levels,thus having a clear understanding the difference in acknowledging the difference between China’s hospitals and America’s hospitals. |
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