非医疗卫生机构医学伦理委员会现状及挑战

我国非医疗卫生机构正处于建立健全伦理委员会的阶段，其伦理委员会常见问题包括无针对性的伦理审查规范，审查能力无法匹配需求，伦理监管难以护航创新，可参考的指南和标准操作规程有限，研究者伦理知识有待提高，跟踪审查落实困难。鉴于此，建议落实法规基本规定，建立健全伦理委员会，人财物支持，提升委员审查能力，实行研究者准入制，建立伦理委员会认证制度和借鉴国外高等院校经验，以期加快非医疗卫生机构伦理委员会建设。

Current Situation and Challenges of Medical Ethics Committees in Non-medical Health Institutions

Non-medical health institutions in China are currently in the stage of establishing and improving ethics committees. Common issues with ethics committees include the lack of targeted ethics review standards, inadequate review capabilities to meet needs, challenges in ethics supervision hindering innovation, limited guidelines and standard operating procedures for reference, a need for improvement in ethics knowledge among investigators, and difficulties in tracking and implementing reviews. In view of this, the author recommends to implement basic regulations, establish and improve an ethics committee, provide human and financial support, enhance the review ability of committee members, implement a researcher admission system, establish an ethics committee certification system, and learn from the experience of foreign higher education institutions, in order to expedite the construction of ethics committees in non-medical health institutions.