Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada.
J Crit Care. 2012 Jun;27(3):225-31. doi: 10.1016/j.jcrc.2011.12.012. Epub 2012 Feb 4.
Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial.
We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF).
Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits.
More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards.
研究伦理委员会（REB）对科学方案的审查至关重要，可确保参与者的尊严、安全和权利。本研究的目的是考察从提交到批准的时间，分析批准时间的预测因素，并描述评估国际血栓预防试验的 REB 的条件范围。
我们通过文献回顾和研究人员讨论生成了调查项目，创建了 4 个领域：受访者和机构人口统计学、REB 申请流程和替代同意模型。我们进行了文件分析，对协议和知情同意书（ICF）的 REB 审查中的主题进行了重复评估。
来自 65 个 REB 机构的批准，需要 58 个独特的申请。我们分析了 44 个（75.9%）的 58 个文件和调查。完成申请的调查受访者有 8 年（5-12 年）的经验；77%的人在过去 5 年中完成了 4 次或更多次 REB 申请。危重病科人员占 REB 的 54%。批准时间中位数（四分位距）为 75 天（42，150），有国家研究联盟成员资格的站点时间更长（89.1 与 31.0 天，P=0.03）。应用程序流程和 ICF 的文件分析产生了 5 个主题：方法、数据管理、同意程序、编目和杂项。专门针对协议的主题侧重于试验实施、外部评论和预算。仅针对 ICF 的主题是风险和益处。对协议和 ICF 的最常见评论是关于方法和杂项问题；ICF 评论还涉及研究风险和益处。
在保持高标准的伦理的同时，需要对临床试验的 REB 审批程序进行提高效率和一致性的方法进行更多研究。
