我院科研课题伦理审查的问题与对策探讨

Problems and countermeasures of ethical review of scientific research projects in our hospital

伦理审查作为规范研究行为、控制研究风险的重要手段,在医院科研课题临床研究增多和精细化管理面前,遭遇一定的问题与挑战。本文针对首都医科大学附属北京胸科医院科研课题伦理审查中遇到的伦理知识知晓、审查方式选择、样本库伦理及跟踪审查等问题的影响因素和原因进行深入分析,并提出加强委员准入、考核和培训,丰富伦理审查形式,强化与学术审查协同,规范样本库泛知情签署流程,推进伦理追踪审查等相应的解决对策。本文认为准确把握科研课题实施和遵循伦理间的平衡点,确保临床科研健康规范地发展,对提高医院科研课题临床研究的伦理审查质量,完善伦理审查体系,有较强的实用价值。在未来,要结合国际国内及医院的相关标准和实际情况,制定对于临床科研课题的伦理审查规范将是我们下一步的工作重点,并为其他医院开展科研课题伦理审查提供借鉴。

As an important means of standardizing research behavior and controlling research risk,ethical review has encountered some problems and challenges in the face of the increase of clinical research and fine management of hospital scientific research projects.This paper makes an in-depth analysis on the influencing factors and causes of ethical knowledge awareness,review mode selection,sample bank ethics,and follow-up review in the ethical review of scientific research projects in Beijing Chest Hospital,Capital Medical University,and puts forward to strengthen member access,evaluation and training,rich ethical review form,and strengthen coordination with academic review,standardize the process of informed signature of sample database,and promote the the ethical tracking and review and other corresponding solutions.This paper holds that accurately grasping the balance between the implementation of scientific research projects and following ethics to ensure the healthy and standardized development of clinical scientific research has strong applicable value for improving the ethical review quality of clinical research of hospital scientific research projects and perfecting the ethical review system.In the future,it will be our next focus to formulate ethical review norms for clinical scientific research topics based on the relevant international,domestic and hospital standards and actual conditions,and provide reference for other hospitals to carry out ethical review of scientific research topics.