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临床研究中电子知情同意受试者首选意愿及影响因素研究

Study on subjects'preferred intention and influencing factors of electronic informed consent in clinical re-search

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目的 通过调查受试者对电子知情同意使用的意愿分析其影响因素,为电子知情同意未来推广提供理论基础.方法 设计调查问卷,通过临床研究协调员向受试者发放,运用单因素和多因素分析影响受试者首选电子知情同意的影响因素.结果 使用过电子知情同意的受试者中对电子知情同意整体满意度均呈正向评价.57.48%的受试者愿意首选电子知情同意.多因素分析结果显示,年龄、泄露隐私担心程度和电子知情形式有助于保存被认可程度3指标为影响因素.结论 电子知情同意要做到内容的充分告知、语言的通俗易懂,给予受试者公平的选择和自愿做出的决定.在知情过程中要依法依规保护受试者隐私.通过以上各项措施提升受试者对电子知情同意的首选意愿.未来电子知情同意的发展还仍需相关政策的落地支持、技术设备不断完善和相关部门的监管.
Objective This study aims to investigate the willingness of subjects to use electronic informed consent and analyze its influencing factors,so as to provide theoretical basis for the promotion of electronic informed consent.Methods Questionnaires were designed and distributed to subjects through clinical research coordinator.Univariate and multivariate anal-ysis were used to analyze the influencing factors of subjects'preferred electronic informed consent.Results All the subjects who had used e-informed consent had a positive evaluation on their overall satisfaction.57.48%of subjects preferred electronic informed consent.The results of multi-factor analysis showed that age,the degree of concern about privacy disclosure and the electronic form were the 3 influencing factors.Conclusions Electronic informed consent should be fully informed of the con-tent,the language should be easy to understand,and the subject should be given a fair choice and a voluntary decision.The subject's privacy must be protected in accordance with laws and regulations during the informed process.We should enhance the preferred willingness of subject to electronic informed consent through the above measures.The future development of elec-tronic informed consent still needs the support of relevant policies,the continuous improvement of technical equipment and the supervision of relevant departments.

Clinical researchElectronic informed consentSubject referenceInfluencing factors

左旭、黄樱硕、李悦、邢荔函、郭水龙

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首都医科大学附属北京友谊医院科技处,北京 100050

临床研究 电子知情 受试者 首选意愿

2024

中华医学科研管理杂志
中华医学会

中华医学科研管理杂志

CSTPCD
影响因子:0.515
ISSN:1006-1924
年,卷(期):2024.37(6)