1Divison of Pulmonary and Critical Care Medicine, Emory University, Atlanta, GA. 2Division of Trauma, Critical Care and Emergency Surgery, University of Arizona, Tuscon, AZ. 3Departments of Medicine and Surgery, University of Maryland, Baltimore, MD. 4Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University, Nashville, TN.
Crit Care Med. 2014 May;42(5):1105-9. doi: 10.1097/CCM.0000000000000133.
To characterize variation in the institutional review board application process of a multicenter, observational critical care study.
DESIGN, SETTING, AND SUBJECTS: Survey analysis of 36 investigators who applied for participation in the United States Critical Illness and Injury Trials Group: Critical Illness and Outcomes Study, an observational study of 69 adult ICUs.
None.
Analysis of investigator-specific characteristics, institutional review board process, application and approval dates, and level of difficulty in obtaining approval. Surveys were analyzed from 36 sites (95%) that applied for institutional review board approval. Level of review ranged from full board, expedited, to exempt. Seventy-five percent of applications were submitted by an experienced investigator while 25% were submitted by a less experienced investigator. Median time to institutional review board approval was 30 days (interquartile range, 14-54) and ranged from 5 days to 5.5 months. Time to approval was 29 days (interquartile range, 17-48) for applications submitted by an experienced investigator compared with 97 days (interquartile range, 25-159) for those submitted by a less experienced investigator (p = 0.08). Subjective level of difficulty was significantly higher for less experienced investigators (4 of 10; interquartile range, 2-8) vs experienced investigators (2 of 10; interquartile range, 1-3) (p = 0.04). Four sites cited institutional review board concern regarding waiver of consent as a major barrier to approval and were required to perform revisions or participate in board meetings regarding this concern.
In a multicenter, observational critical care study, significant variation was observed between sites in all aspects of the institutional review board evaluation and approval process. The level of difficulty was significantly higher for less experienced investigators with a trend toward longer time to institutional review board approval. Variation in institutional review board interpretation of waiver of informed consent regulations was cited as a major barrier to approval.
描述一项多中心观察性重症监护研究的机构审查委员会申请流程的变化。
设计、地点和研究对象：对 36 名参与美国重症疾病和损伤试验组：重症疾病和结局研究的研究者进行调查分析，该研究是一项对 69 个重症监护病房的成年患者进行的观察性研究。
无。
分析了研究者特定特征、机构审查委员会流程、申请和批准日期以及获得批准的难度。对申请机构审查委员会批准的 36 个站点（95%）进行了调查分析。审查级别从全委员会、加速审查到豁免审查不等。75%的申请由经验丰富的研究者提交，而 25%的申请由经验较少的研究者提交。机构审查委员会批准的中位时间为 30 天（四分位间距，14-54），时间范围为 5 天至 5.5 个月。由经验丰富的研究者提交的申请的批准时间为 29 天（四分位间距，17-48），而由经验较少的研究者提交的申请的批准时间为 97 天（四分位间距，25-159）（p = 0.08）。经验较少的研究者主观上认为难度明显更高（10 分制，4 分；四分位间距，2-8），而经验丰富的研究者（10 分制，2 分；四分位间距，1-3）（p = 0.04）。有 4 个研究点认为机构审查委员会对放弃知情同意的担忧是批准的主要障碍，并被要求对此进行修订或参加委员会会议。
在一项多中心观察性重症监护研究中，机构审查委员会评估和批准过程的各个方面在不同研究点之间存在显著差异。经验较少的研究者的难度明显更高，机构审查委员会批准的时间也更长。机构审查委员会对放弃知情同意法规的解释存在差异，被认为是批准的主要障碍。
