深圳市《涉及人的生物医学研究伦理审查规范》解读

Interpretation of the Operational Guideline for the Ethic Review of Biomedical Research Involving Human Subject in Shenzhen

为了提升深圳市各医疗机构伦理委员会能力建设水准,满足制度建设的迫切需求,深圳市卫生健康委员会统筹规划起草了《涉及人的生物医学研究伦理审查规范》。作为深圳市地方标准,规定了深圳市各伦理委员会达到的能力建设基本要求,旨在通过细化明确伦理审查要求及流程、知情同意内容和规程、各类工作用表等加强各伦理委员会制度的系统化、标准化建设。规范主要创新点包括:接轨国际伦理前沿最新进展要求,制定了可操作性强的伦理审查工作流程与制度模板、明晰了机构的监管与支持责任,促进了程序伦理与实质伦理的结合。在深圳市伦理委员会制度的标准化建设方面,发挥了积极作用。

In order to improve the capacity building level of the ethics committees of various medical institutions in Shenzhen and meet the urgent needs of system construction,the Health Commission Shenzhen has drafted the Operational Guideline for the Ethic Review of Biomedical Research Involving Human Subject.As a local standard in Shenzhen,it stipulated the basic requirements for the capacity building of the ethics committees in Shenzhen.It aimed to strengthen the systematic and standardized construction of ethics committee systems through detailed and clear ethical review requirements and procedures,informed consent content and procedures,and various work schedules.The main innovations of this guideline were as follows,including:conforming to the latest developments in the frontiers of international ethics,formulating a highly operable ethical review workflow and system template,clarifying the supervision and support responsibilities of institutions,and promoting the integration of procedural ethics and substantive ethics.It has played an active role in the standardization construction of ethics committee system in Shenzhen.