受试者保护体系内各部门职责与协作研究

Study on responsibilities and cooperation of each department within the Human Research Protection Program

在临床研究的实际开展过程中,医疗机构通过由多个委员会和相关行政部门构建的受试者保护体系,相互协作,共同实现保护受试者的目标。作者详细阐述了受试者保护体系内研究者、临床科室等研究实施的主体,科研处、药物临床试验机构办公室等行政管理科室,科学审查委员会、伦理委员会等负责临床研究项目的科学性、伦理性审查的委员会,以及研究药品管理、生物安全管理、经费合同管理等在内的临床研究各支持部门的具体工作职责。在医疗机构受试者保护体系的运行管理过程中,需要关注临床研究的全流程管理和质量控制,持续加强科研伦理的专项教育培训,注重受试者保护体系内各部门的沟通交流及协作,达到受试者保护体系持续质量改进的目标。

In the actual development of clinical research,medical institutions work together to achieve the goal of protecting research subjects through a Human Research Protection Program(HRPP)constructed by multiple committees and relevant administrative departments.This paper elaborates the specific job responsibilities of each committee and administrative department within the HRPP.In the HRPP,the researchers and clinical departments conduct research.The scientific research department and the GCP office are the administrative departments of clinical research.The Scientific Review Committee and the Ethics Committee(EC)conduct the scientific review and ethical review of clinical researches.Other clinical research supporting departments are responsible for the distribution of research medication,biosecurity management,funding,and contract management,etc.In the HRPP managing process,attention should be paid to the whole process management and quality control of clinical research,continuously scientific and ethical training,communication,and cooperation among different departments within the HRPP,in order to achieve the goal of continuous quality improvement of the HRPP.