人类研究保护项目认证协会:为人类研究保护提供全面,综合的方法(英文)

Association for the Accreditation of Human Research Protection Programs:advancing a comprehensive,integrated approach to human research protections

研究型企业最重要的责任之一是保护参与临床研究实验和其他研究实验的志愿者的安全。多年来,这个责任主要是机构审查委员会和伦理委员会负责,但他们当中的许多机构已经负担过重不能面对日益复杂的全球化研究企业所面临的挑战。2000年,在一系列美国研究保护措施失败后,政府和学术界带头人倡导一种系统性、综合性的方法来完成相关保护工作的研究,他们对人类研究保护项目认证协会在推进新方法同时可能会促进研究保护和研究质量也进行了讨论。人类研究保护项目认证协会(Association for the Accreditation of Human Research Protection Programs,AAHRPP)成立于2001年,自从它成立后就成了人类研究保护项目的全球领导者,并一直致力于人类保护研究计划(Human Research Protection Programs,HRPPs),提高研究保护水平,帮助HRPPs在现在以及今后的几年里建立医学伦理研究基金会。

One of the overriding responsibilities of the research enterprise is to protect those who volunteer for clinical trials and other research studies.For years,that responsibility rested primarily with institutional review boards and ethics committees,many of which were overburdened and ill-equipped to meet the challenges of an increasingly complex and global research enterprise.In 2000,after a series of U.S.research protection failures,government and academic leaders began advocating for a systemic,integrated approach to research protections—one that begins at the highest level of an organization.These same leaden argued that accreditation could play a key role in advancing this new approach and improving both research protections and quality.The Association for the Accreditation of Human Research Protection Programs（AAHRPP）was founded in 2001 and has since emerged as the global leader in accrediting human research protection programs（HRPPs）.In the process,AAHRPP has been instrumental in achieving acceptance of HRPPs,raising standards for research protections,and helping HRPPs lay the foundation for ethical research today and in the years to come.