从知情同意试验的儿科例外中衡量社区咨询的有效性
Ann R Johnson1, Naomi O Riches2, John M VanBuren3
1College of Nursing, University of Utah, Salt Lake City, Utah, USA.
概括
社区紧急研究商 (EFIC) 已接触到相关社区,但家长采访显示了机构审查委员会考虑加强参与者保护的其他关键主题.
科学领域:
- 临床研究伦理学
- 公共卫生研究 公共卫生研究
- 紧急医疗 紧急医疗
背景情况:
- 社区咨询是美国食品和药物管理局授权的,除了在紧急情况下的知情同意 (EFIC) 研究外.
- 对机构审查委员会 (IRB) 来说,评估这些商的有效性是一个挑战.
- 这项研究评估了PediDOSE试验的社区咨询有效性.
研究的目的:
- 确定咨询工作是否达到了相关社区.
- 评估社区的观点是否与注册家长的观点一致.
- 为未来的EFIC试验确定重要的主题.
主要方法:
- 来自社区咨询的半结构面试的定性分析.
- 咨询主题与PediDOSE试验中儿童的父母的采访数据的比较.
主要成果:
- 大多数主题在社区咨询和注册家长之间重叠.
- 其他主题出现在家长采访中,提供了独特的见解.
- 尽管有人口差异,但观察到有显著的主题重叠.
结论:
- 父母采访提供了比初始咨询更深入的理解.
- 治疗误解是在家长采访中发现的,而不是咨询.
- 适度的数据收集调整可以有效地评估EFIC社区咨询的有效性.
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