医学伦理学专业人员在涉及人类受试者临床科研伦理审查中的作用发挥

The Function of Medical Ethics Professionals in Ethical Review of Clinical Trials Involving Human Subjects

医学伦理学专业人员因其具备扎实的伦理学专业知识,在充当医院伦理委员会的专业类成员的角色时,应当充分发挥其学科优势。在进行伦理审查前,首先需要学习国际国内的系列法规、文件,并适时与同行进行交流。在审查时要重点审查研究项目的必要性、安全性,结合医学伦理学原则对方案进行全面审查,掌握知情同意书的审查要点,从而履行好保护人类受试者权益的职责。

The medical ethics professionals which have resourceful ethical knowledge ought to give full play to subjects superiority in the review of the clinical trials involving human subjects. Before ethical review,it is needed to learn the series of international and domestic laws,regulations,and documents,and communicate with peers timely. In the review,they should focus on the necessity and security of the research project,conduct a comprehensive review combined with the principle of medical ethics,and master the review key point of informed consent,to fulfill their duty of protection of human rights of subjects.