#consented - 一个语义上的同意代码,以促进一致的文档和协作医学研究中的同意的实施
Martin Bialke1, Christopher Hampf1, Arne Blumentritt2
1Institute for Community Medicine, Department Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17475 Greifswald, Germany.
International journal of medical informatics
|July 17, 2024
概括
一个新的语义同意码 (SCC) 标准化了跨研究网络的患者数据权限. 该代码可以更轻松地查询同意数据,改善研究项目的数据可访问性.
科学领域:
- 医疗信息学 医疗信息学
- 生物伦理学生物伦理学
- 数据管理数据管理
背景情况:
- 国际研究网络使用不同的患者同意方法,使新项目的数据使用变得复杂.
- 现有的同意管理是耗时的,缺乏跨项目可查询性.
- 需要一个标准化,可查询的患者同意框架.
研究的目的:
- 开发基于许可 (Opt-In) 的方法来绘制和查询患者的同意和撤回.
- 为同意政策创建一个标准化的语义术语.
- 在研究网络中提高数据的可访问性和可用性.
主要方法:
- 分析当前的研究方法和同意政策的可重复使用性.
- 抽象选择的流程模型的同意政策定义.
- 为同意政策制定标准化语义术语的开发和专家验证.
- 评估开发的代码的适用性.
主要成果:
- 一个三轴 (CLASS,ACTION,PURPOSE) 语义同意代码 (SCC) 被开发和发布.
- 该SCC使用国家研究协会的现实世界同意证明了价值.
- 成功评估使用SCC的手动和自动化同意映射和解释.
- 介绍了一种在不同研究环境中简化同意查询的概念.
结论:
- 语义同意码 (SCC) 在初步评估中取得了成功.
- 三轴SCC是标准化各种不同同意文本的基本步骤.
- 建议通过社区投入对SCC进行代扩展,以获得更广泛的采用和功能.
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