在使用从诊断实验室获得的剩余样本和相关个人数据时存在道德问题
Federico Remes Lenicov1, Nilda E Fink2
1Instituto de Investigaciones Biomédicas en Retrovirus y SIDA (INBIRS), Universidad de Buenos Aires / CONICET, Buenos Aires, Argentina.
概括
临床实验室可以改善对剩余样品的二次使用的伦理合规性. 采用广泛的知情同意或生物银行可以提高研究贡献,同时保护参与者的权利.
科学领域:
- 生物医学科学 生物医学科学
- 临床诊断 临床诊断 临床诊断
- 研究伦理学研究伦理学
背景情况:
- 诊断实验室对于生物医学研究至关重要,提供临床特征样本.
- 随着COVID-19的流行,实验室中人类样品的伦理管理实践变得多样化.
- 剩余样本,临床使用的残留物,对二次研究提出伦理考虑.
研究的目的:
- 概述目前在临床实验室使用剩余样品的伦理框架.
- 讨论机构道德监督的必要性和对二次样本使用的知情同意.
- 探索正在进行的关于基于最小风险的同意豁免的辩论.
主要方法:
- 审查现有的关于人类样本使用的伦理准则和法规.
- 对要求对风险最小的研究提供知情同意的论点的分析.
- 讨论在诊断环境中道德样本管理的最佳实践.
主要成果:
- 样品的二次使用通常需要道德监督和参与者的同意.
- 关于最小的风险是否可以证明放弃知情同意是合理的,存在争议.
- 目前的做法各不相同,有些实验室缺乏强大的道德框架.
结论:
- 计划使用二次样本的实验室应该考虑广泛的知情同意.
- 实施有组织的生物银行可以提高道德合规标准.
- 加强伦理实践提高了实验室为科学知识生产做出贡献的能力.
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