涉及心理社会残疾人的研究治理
Marisha Wickremsinhe1, Sarah Carrecedo2, Aminu Yakubu3,4
1London School of Hygiene and Tropical Medicine, London, UK.
Wellcome open research
|August 30, 2024
概括
研究伦理法规通常与CIOMS指导方针保持一致,但缺乏CRPD原则,包括心理残疾人. 建议进行修订,以弥合这一差距,并确保公平的参与研究.
科学领域:
- 生物伦理学生物伦理学
- 人权法 人权法 人权法
- 公共卫生政策 公共卫生政策
背景情况:
- 卫生研究伦理在全球范围内受到监管,国际医学科学组织理事会 (CIOMS) 的指导方针作为一个关键的国际标准.
- 联合国残疾人权利公约 (CRPD) 为残疾人权利提供了框架,影响了研究伦理,特别是关于法律能力和决策.
- 现有的法规通常支持将心理残疾人纳入研究,正如CIOMS所概述的那样,但可能不完全符合CRPD原则.
研究的目的:
- 评估某些司法管辖区的研究伦理法规与CIOMS指导方针和联合国残疾人权利公约 (CRPD) 的一致性.
- 发现现行法规中关于将心理残疾人纳入与健康相关的研究中的差距.
- 建议修订研究伦理法规,以协调CIOMS和CRPD的原则,特别是关于替代性决策和参与研究的权利.
主要方法:
- 对26个非洲国家的研究伦理法规进行了广泛分析.
- 深入的案例研究检查了马来西亚和秘鲁的法规.
- 对国家法规的比较审查与CIOMS与人类有关的健康相关研究的国际伦理准则和联合国残疾人权利公约.
主要成果:
- 许多国家的研究伦理法规与CIOMS指南的重要方面保持一致.
- "儿童权利公约"的核心原则,特别是关于普遍法律能力的原则,在现有的研究伦理法规中基本上不存在.
- 在CIOMS和CRPD框架之间存在着明显的紧张关系,涉及心理残疾人参与研究的权利.
结论:
- 目前的研究伦理法规需要进行重大修订,以充分纳入CRPD中概述的权利和原则.
- 需要修订法规,以解决心理残疾人参与研究的权利,在适当的情况下超越替代性决策.
- 实施监管变革可以弥合现有的道德准则与国际人权标准之间的差距,促进更具包容性的健康研究.
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