某三甲医院五年科研项目伦理审查情况分析

通过对国内某三甲医院五年科研伦理审查情况进行分析,探讨科研项目伦理审查工作的重点、难点及对策。汇总2013年~2017年经医学伦理委员会会议审查的科研项目,分析研究者的学历、职称、学科与通过率关系。近5年医学伦理委员会共审查科研项目285项,通过238项,未通过47项,其中内科通过率高于外科(P<0.05),副高以上职称通过率高于中级(P<0.05),研究生以上学历通过率高于本科及以下学历(P<0.05)。只有强化伦理意识,规范审查形式,健全监管机制,才能保证科研伦理工作健康规范发展。

Investigation on Ethical Review of Scientific Research in a Tertiary Hospital in the Last Five Years

This article examines the ethical review of scientific researches in a tertiary hospital in the last five years, with the analysis of the review contents, difficulties and strategies.The ethical reviews of scientific researches conducted by medical ethics committee of the hospital from 2013 to 2017 were collected, and the relationship between the investigator's degree, academic title, discipline and the approval rate were analyzed. In the last five years, the medical ethics committee had reviewed 285 scientific researches, 238 of which had passed and 47 of which had not passed. Among them, the passing rate of internal medicine was higher than that of surgery (P<0.05), the passing rate of investigators' with associate senior titles or above was higher than that of the intermediate level (P<0.05), and the passing rate of investigators' education level with post-graduation was higher than that of the under-graduation or below (P<0.05). Only by strengthening the awareness of ethics, standardizing the form of examination and improving the supervision mechanism can we ensure the sound and standard development of scientific research ethics.