药学科技期刊在科研伦理审查体系构建与执行中的实践进展与理论反思

    Practice Progress and Theoretical Reflection on the Construction and Implementation of the Research Ethical Review System in Pharmaceutical Science Journals

    • 摘要:
      目的 深入调研与分析中国69本药学类科技期刊的伦理审查体系构建和落实现状,为提升中国科技期刊伦理审查标准提供切实可行的策略性建议。
      方法 采用多维度调研方法,通过查阅69本药学类科技期刊官方网站的投稿指南、伦理政策版块,同时模拟投稿流程,全面了解各期刊伦理审查体系的构建情况;随机选取630篇近年来各期刊涉及人的生命科学和医学研究以及动物实验研究论文,对其伦理审查信息完整性进行系统审查。
      结果 在制度建设层面,仅49.21%的期刊在投稿指南中提及伦理审查要求,14.29%的期刊官网设有专门伦理版块,投稿系统明确伦理审查要求的期刊仅占20.97%。论文审查数据显示,涉及人的生命科学和医学研究类论文中,有75.48%的论文提供伦理审查信息,动物实验类论文中该比例仅为50.00%。这表明中国药学类科技期刊伦理审查要求不够明确,执行力度亟待加强,伦理审查体系尚不完善。
      结论 为推动中国药学类科技期刊伦理审查的规范化和专业化发展,需从多方面协同发力。应强化主管、主办单位的引领作用,完善顶层设计;提高期刊审读抽查对伦理审查的重视程度,加强监督;推动期刊自身优化伦理审查制度,细化执行标准;同时加强编辑和审稿人对伦理审查知识的学习与应用,提升专业素养,从而全面完善中国药学类科技期刊的伦理审查体系建设。

       

      Abstract:
      OBJECTIVE  To conduct an in-depth investigation and analysis of the construction and implementation status of the ethical review systems of 69 pharmaceutical science and technology journals in China, and provide practical strategic recommendations for improving the ethical review standards of domestic scientific journals.
      METHODS  A multi-dimensional research approach was adopted. Firstly, the study involved reviewing the submission guidelines and ethical policy sections on the official websites of 69 pharmaceutical science and technology journals, as well as simulating the submission process to comprehensively evaluate the construction of their ethical review systems. Secondly, 630 research papers related to science and medical studies involving humans and animal experiments published in these journals in recent years were randomly selected for systematic examination of the completeness of their ethical review information.
      RESULTS  At the system construction level, only 49.21% of the journals mentioned ethical review requirements in their submission guidelines, 14.29% had dedicated ethical policy sections on their official websites, and merely 20.97% specified ethical review requirements in their submission systems. Data from paper reviews showed that 75.48% of papers related to science and medical research involving humans provided ethical review information, while the rate was 50.00% in animal experiment research papers. These findings indicated that ethical review requirements in Chinese pharmaceutical science and technology journals were not clear enough, enforcement needed to be strengthened, and the overall ethical review system remained incomplete.
      CONCLUSION  To promote the standardization and professionalization of ethical review in Chinese pharmaceutical science and technology journals, multi-faceted collaborative efforts are required. These include strengthening the guiding role of competent authorities and sponsoring units to improve top-level design, increasing the emphasis on ethical review in journal audits and spot checks, encouraging journals to optimize their ethical review systems and refine implementation standards, and enhancing the learning and application of ethical review knowledge among editors and reviewers to improve their professional competence. Through these measures, the ethical review system of Chinese pharmaceutical science and technology journals can be comprehensively elevated.

       

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