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对机构审查委员会的政策进行分析,以招收具有受损或不确定的决策能力的成年人
Emily Nguyen1, David Appiah2, Ari Ne'eman3
1University of Virginia, Charlottesville, VA, USA.
概括
许多机构将决策能力受损的个人排除在研究之外. 政策应该确保公平的包容,同时保护参与者,促进所有人口的健康平等.
科学领域:
- 医学伦理 医学伦理
- 临床研究 临床研究
- 公共卫生 公共卫生
背景情况:
- 从研究中排除决策能力受损的个体违反了正义和公平.
- 这种排斥会对这些弱势群体的健康和福利产生负面影响.
- 当前的机构政策可能导致不合理的排除从参与研究.
研究的目的:
- 分析美国研究机构的机构审查委员会 (IRB) 政策.
- 了解为与不同决策能力的人群工作的调查人员提供的指导.
- 确定研究参与资格标准中的潜在偏见.
主要方法:
- 在94个顶级资助的美国研究机构进行了IRB政策的横截面研究.
- 从公开可用的机构网站收集的数据.
- 为分析政策内容而开发的演和归纳编码框架.
主要成果:
- 41.5%的机构将受影响决策能力的个人排除在外,除非包括在内有科学理由.
- 只有5.3%的政策需要包含,除非排除在科学上有理由.
- 资格标准通常取决于研究风险 (54.3%),对同意 (77.7%) 和能力评估 (44.7%) 的指导有所不同.
结论:
- IRB的政策可能不公平地将不确定的或受损的决策能力的个人排除在研究之外.
- 机构必须审查IRB政策,以平衡参与者保护与公平的研究纳入.
- 修改政策可以确保决策能力受损的成年人免受伤害,并且不会不公平地被排除在研究之外.
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