一个多中心遗传流行病学研究的当地机构审查的问题变化
Rita McWilliams1, Julie Hoover-Fong, Ada Hamosh
1Bloomberg School of Public Health, Johns Hopkins Medical Institutions, Baltimore, Md, USA.
JAMA
|July 17, 2003
概括
多中心遗传流行病学研究在机构审查委员会 (IRB) 的批准中面临显著的变化,导致效率低下和保护不均. 需要集中审查,以简化公共卫生研究的流程.
科学领域:
- 遗传学 是一个遗传学.
- 流行病学 流行病学
- 生物伦理学生物伦理学
背景情况:
- 人类基因组项目使得大规模研究能够将DNA变异与疾病流行病学相关联.
- 多中心遗传流行病学研究对于获得足够的统计能力至关重要.
- 这种研究需要跨多个研究机构的合作.
研究的目的:
- 量化多中心研究审查的行政负担.
- 评估机构审查委员会 (IRB) 对多中心遗传流行病学研究的批准流程的变化.
- 识别人类受试者保护和研究效率的不一致性.
主要方法:
- 进行了PubMed搜索,以追踪多中心研究的出版趋势.
- 对参与的囊性纤维化护理中心进行了关于IRB审查流程的7个问题调查.
- 收集关于IRB会议频率,提交时间表,同意表格要求,审查类型和要求修改的数据.
主要成果:
- 发表的多中心遗传流行病学研究在1985年至2002年间增加了8到9倍.
- 对单个遗传流行病学研究的IRB审查显示了显著的变异性,其中77%接受了全面审查.
- 国际风险投资委员会在同意要求 (1-4表格) 和担忧方面表现出不一致,其中52%专注于遗传方面的问题.
结论:
- 对于多中心遗传流行病学研究的本地IRB审查是高度可变和低效的.
- 在IRB流程中缺乏统一性会损害人体受试者保护,并造成行政负担.
- 建议采用集中审查机制,以解决效率低下的问题,并提高研究监督的一致性.
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