以受试者为中心的知情同意方式在护理研究中的应用

摘要

目的 探讨以受试者为中心的知情同意方式在护理研究中的运用及其效果.方法 在一项对乳腺癌患者进行精准症状学研究的预试验中尝试采用以受试者为中心的知情同意方式,具体为:统一培训研究人员、规范知情同意书的讲解、给受试者留充足时间自行阅读知情同意书、鼓励受试者向研究者提问、确认受试者完全理解知情同意书、受试者及研究人员共同签署知情同意书、最后采用稽核表审查整个过程.统计分析受试者对知情同意书的理解情况、提问情况及对知情同意过程的反馈.结果 96.67％的患者能完全自行阅读知情同意书;有3名受试者在知情同意过程中向研究者提问;受试者对知情同意过程的反馈较为满意.结论 以受试者为中心的知情同意过程,确保了受试者的知情同意权得到充分尊重,是保证受试者真正知情同意的重要措施.%Objective:To explore the effect of subject-centered informed consent in nursing research.Methods:We adopted the subject-centered informed consent in a pilot study on precision symptom in breast cancer patients.Specific measures were taken included offering training for researchers about skills regarding subject-centered informed consent,standardizing the explanation for the informed consent forms,allowing sufficient time for subjects to read the informed consent forms,encouraging subjects to raise questions to researchers,confirming that the subject were fully informed and understood the contents,subjects and researchers jointly signing,and finally,using the checklist to review the entire process.The questions and feedback about the subject-centered informed consent were statistically analyzed.Results:Almost all of patients(96.67％) were able to read the consent forms by themselves,three subjects raised questions to the researcher after reading the forms,and all subjects in our study were satisfied with the informed consent process.Conclusion:The subject-centered informed consent approach makes sure that the subjects' fights of informed consent are fully respected and is an important measure to ensure subjects' fights of informed consent.