科学性审查、伦理审查时机、审查标准的正确把握,科研项目受试者伤害的补偿与赔偿,以及伦理审查与科研诚信管理的关系都是医学临床科研伦理审查中常见的问题。本文就这些问题进行深入探讨,通过借鉴国际通行原则,提出个人观点,供各位同道参考。
Scientific review, time schedule of ethical review, standards of review, the compensation for injuries of subjects in clinical research and the relation between the ethical review and scientific integrity are common issues in ethical review of clinical research. This paper had an in-depth discussion on issues mentioned above. The international rules were referred and the personal suggestions were also provided for the reference in further discussion.