三级医院医师医学科研伦理审查规范认知现状及影响因素分析

Analysis of Cognition Status and Influencing Factors of Medical Research Ethics Review Standards among Physicians in Tertiary Hospitals

目的 了解三级医院医师对医学科研伦理审查规范认知的现状及影响因素。方法 采用问卷调查法,向河南省三级医院医师发放问卷2 067份,有效回收率为81.95%。结果 (1)医师对《涉及人的生物医学研究伦理审查办法》的认知率为69.01%,对《关于加强科技伦理治理的意见》的认知率仅为34.30%。全部知晓6项(医学)科研伦理审查相关规范的有310人。(2)全部了解4项医学伦理基本原则的有1 153人。(3)78.98%的医师接受过医学科研伦理知识培训,医学院、专题讲座学习更容易了解医学科研伦理知识(P<0.05)。(4)二元logistic回归分析结果显示:文化程度、是否是伦理委员会成员、是否接受过伦理培训对医师了解医学科研伦理知识有明显影响(P<0.05)。结论 医师对新颁布的医学科研伦理审查规范认知度较低,相关机构需针对性地开展培训以提升医师科研伦理素养。

Objective To understand the cognition status of medical scientific research ethics review norms among physicians in tertiary hospitals and the factors influencing their awareness. Methods A survey was conducted using a questionnaire. A total of 2 067 questionnaires were distributed to physicians in tertiary hospitals in Henan Province,with an effective response rate of 81.95%. Results(1) Physicians' awareness rate of Regulations on Ethical Review of Biomedical Research Involving Human Subjects reached 69.01%,while that of Opinions on Strengthening Ethical Governance in Science and Technology was only 34.30%. A total of 310 respondents were aware of all six medical research ethics-related regulations.(2) 1 153 respondents were familiar with all four basic principles of medical ethics.(3)78.98% of physicians had received training in medical research ethics knowledge. Learning through medical school and special lectures made it easier for physicians to understand medical research ethics knowledge(P<0.05).(4)The results of binary logistic regression analysis showed that educational level,membership in an ethics committee,and receipt of ethics training significantly influenced physicians' understanding of medical research ethics knowledge(P<0.05). Conclusion Physicians have low awareness of newly issued medical research ethics review norms,targeted training is needed to enhance physicians' research ethics literacy.