临床医学教学研究课题伦理审查常见问题分析

临床医学教学研究课题常见的伦理问题包括混淆常规教学与课题研究、混淆理论教学与临床教学、自行做出“豁免知情同意”判断、混淆临床试验与教学研究、忽视“间接受试者”选择的公正性等。分析其深层次原因，发现主要包括对风险的防范意识与“爱伤”观念未有机结合、在课题设计阶段并未考虑风险控制的问题、对伦理学原则特别是知情同意原则理解不深。因此，研究项目主持者应该增强风险意识、提高伦理修养、自觉树立保护受试者利益的意识、认真履行知情同意程序。

Analysis of Common Problems in Ethical Review of Clinical Medicine Teaching Projects

Common ethical problems in clinical medicine teaching projects include the confusion between routine teaching and project research, the confusion between theoretical teaching and clinical teaching, self-judged "exemption of informed consent", the confusion between clinical trials and teaching research, and ignoring "indirect subjects" selection fairness, etc. This article analyzes the deep reasons, which include absent bonding between risk awareness and "love hurt" concept, thoughtless risk control in project design stage, and insufficient understanding to ethical principles, especially the principle of informed consent. Therefore, the host of the research project should enhance risk awareness, improve ethical cultivation, consciously establish the awareness of protecting the interests of the subjects, and earnestly perform the informed consent procedure.