基于内容分析法的献血者知情同意现状分析  

Status analysis of informed consent of blood donors based on content analysis

作　　者：李静[1] 刘杰 陈涵[1] 姜东兰 邱艳[1] LI Jing;LIU Jie;CHENHan;JIANG Donglan;QIU Yan(Beijing Red Cross Blood Center,100088,China)

机构地区：[1]北京市红十字血液中心,北京100088

出　　处：《中国输血杂志》2023年第1期45-48,共4页Chinese Journal of Blood Transfusion

摘　　要：目的 了解献血者书面知情同意内容的现状与不足,确保献血者知情同意遵从伦理规范和管理要求。方法 采用立意取样法,于2022年1月1日~31日收集北京、上海、天津、重庆、广州、浙江地区的6家采供血机构的《献血者知情同意书》及《健康状况征询表》,通过内容分析法借助EXCEL电子表格,以每一家的《献血者知情同意书》及《健康状况征询表》中涉及个人知情同意内容作为1个分析单元,建立信息披露形式等7个一级编码、告知内容题目等19个二级编码、献血前应知内容等56项细目后,做频数统计。结果 6份文本包含的知情同意要素有信息披露形式、献血过程及风险、信息的真实性、献血者屏蔽要求、输血传播感染筛查、血液的其他用途、同意决定,频数≥4的二级编码,包括知情同意书题目、如实提供健康征询信息、实名制献血等12项,占63.16%(12/19),其中献血后注意事项、隐私保密说明、退出属于“未说明”项。56项细目出现频数为1~6的占比分别为55.36%(31/56)、12.50%(7/56)、10.71%(6/56)、17.86%(10/56)、1.79%(1/56)、1.79%(1/56)。结论 各地采供血机构知情同意书及健康状况征询表对献血者发挥了一定解释和知情同意的作用,但内容较分散且缺乏规范,信息告知侧重屏蔽要求,缺少关爱和隐私保护话语、同意决定过程不充分等问题。应建立符合规范的献血者知情同意的内容框架,增加献血者关爱等内容告知,并重视同意决定的过程。Objective To understand the current status and shortcomings of the informed consent of blood donors, and to ensure that the informed consent of blood donors complies with ethical norms and management requirements. Methods From January 1 to 31, 2022, the "Informed Consent Form for Blood Donor" and "Health Status Consultation Form", issued by 6 blood services in Beijing, Shanghai, Tianjin, Chongqing, Guangzhou and Zhejiang, were collected. The contents regarding individual informed consent were set as an analysis unit;7 first-level codes such as the form of information disclosure, 19 second-level codes such as the title of the content to be informed, and 56 items such as the content to be informed before blood donation were established to make frequency statistics. Results The informed consent, issued by six blood centers, included such elements as the form of information disclosure, blood donation process and risks, authenticity of information, donor shielding requirements, screening for transfusion-transmitted infections, other uses of blood, and consent decisions. The second-level coding with frequency≥ 4 included 12 items(63.16%), such as the title of informed consent, truthful provision of health consultation information, and blood donation under real-name, of which precautions after blood donation, privacy statement, and withdrawal were "unexplained" frequency codes. The proportion of 56 items with frequency 1~6 was 55.36%, 12.50%, 10.71%, 17.86%, 1.79% and 1.79%, respectively. Conclusion The informed consent forms and health status consultation forms play a certain role in explaining and conducting informed consent in different places, but some contents are scattered and lack of specifications, information notification weights in shielding requirements while lacks post-donation care and privacy protection, and the decision-making process is inadequate. A standardized content framework for informed consent of blood donors should be established, the caring for blood donors should be promoted, and the full pr

关 键 词：献血者知情同意 内容分析法 采供血机构 献血伦理 

分 类 号：R457.1[医药卫生—治疗学] R193.3[医药卫生—临床医学] B82-057[哲学宗教—伦理学]