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数据注册的知情同意的伦理:超越道德极简主义,走向高层
1Division of Medical Ethics and Law, Stellenbosch University, Cape Town, Western Cape, South Africa.
Bioethics
|June 12, 2025
概括
在全球范围内建立疾病注册表面临着伦理挑战,特别是关于患者对数据使用的同意. 这项分析考察了疾病数据注册表中的知情同意问题,特别是在发展中国家.
科学领域:
- 医疗信息学 医疗信息学
- 生物伦理学生物伦理学
- 公共卫生 公共卫生
背景情况:
- 由于电子健康记录和计算技术的进步,疾病登记册在全球范围内迅速扩大.
- 发展中国家的许多登记处是新生的,与发达国家已建立的不同.
- 伦理问题,包括数据采集,未经同意的转移,第三方数据共享和追溯同意豁免,阻碍了注册表的建立.
研究的目的:
- 提出对疾病数据注册的知情同意的伦理分析.
- 突出发展中国家面临的具体挑战.
- 解决缺乏既定的道德准则和国际最佳实践的问题.
主要方法:
- 对知情同意原则的伦理分析.
- 审查有关疾病登记册和伦理考虑的现有文献.
- 对发达国家与发展中国家的伦理挑战进行比较分析.
主要成果:
- 知情同意是建立疾病登记册的重大伦理障碍.
- 缺乏明确的患者同意数据捕获,传输和共享是普遍存在的.
- 缺乏明确的道德准则加剧了这些问题,特别是在资源有限的环境中.
结论:
- 迫切需要强有力的伦理框架和国际最佳实践,用于疾病登记.
- 解决知情同意问题对于全球疾病登记册的负责任发展和可持续性至关重要.
- 必须优先考虑道德考虑,以确保病人的权利和疾病登记册中的数据完整性.
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