[获取医院临床记录的授权程序:多中心研究的案例]
Rafael Rocha1, Carla Maia2, Luzia Gonçalves3
1Hospital de São João. Unidade Local de Saúde de São João. Porto. Portugal; Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal; Global Health and Tropical Medicine (GHTM, LA-REAL). Instituto de Higiene e Medicina Tropical (IHMT). Universidade NOVA de Lisboa. Lisboa. Portugal.
Acta medica portuguesa
|May 26, 2025
概括
访问葡萄牙研究的临床数据.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 医疗信息学 医疗信息学
- 生物伦理学生物伦理学
背景情况:
- 临床实践产生了大量的数据,有可能产生知识.
- 目前的医疗保健数据主要用于患者护理,研究潜力未得到充分利用.
- 访问这些数据进行研究需要通过复杂的机构审查流程.
研究的目的:
- 描述请求临床记录访问研究的过程.
- 评估葡萄牙卫生机构研究协议审查中的异质性.
- 确定程序性挑战和研究数据访问等待时间.
主要方法:
- 对临床数据访问请求和评估流程的描述性分析.
- 检查葡萄牙国家卫生服务各个实体的程序.
- 研究许可等待时间的记录.
主要成果:
- 在提交临床数据访问请求时存在显著的变化.
- 在不同卫生委员会和伦理委员会对研究方案的评估中观察到的异质性.
- 获得必要的研究授权的漫长等待时间是常见的.
结论:
- 在葡萄牙,获取临床数据用于研究的过程是高度可变和低效的.
- 迫切需要解决围绕研究获取健康数据的伦理和法律问题.
- 简化数据访问对于推动医学研究和知识生成至关重要.
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