Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.
Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards.
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DOI：
10.1016/j.jss.2016.06.004
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发表时间：
2016-08
期刊：
影响因子：
--
通讯作者：
Hall DE
中科院分区：
文献类型：
--
作者：
Varley PR;Feske U;Gao S;Stone RA;Zhang S;Monte R;Arnold RM;Hall DE
尽管人们认为IRB会推迟研究，但很少有人知道需要多长时间才能获得IRB的批准。我们回顾性地量化了10个大型退伍军人事务部（VA）IRB的IRB审查时间。我们从26个最大的VA IRB中的10个收集了与研究方案分层随机样本相关的IRB记录。两名独立分析员从IRB记录中提取日期，从中我们计算了总体和增量审查时间。我们使用多变量线性回归来评估IRB和审查级别（即，豁免、加速或全面审查），并确定潜在目标，以提高IRB审查过程的效率和一致性。在277个方案的样本中，平均审查时间为112天（95%CI：105，120）。与IRB 1的全面审查相比，IRB 3、8、9和10的平均审查时间分别缩短了27（95%CI：6，48）、37（95%CI：11，63）、45（95%CI：20，69）和24（95%CI：2，45）天，IRB 6的时间延长了56（95%CI：28，84）天。在所有IRB中，快速审查比全面审查平均短44天（95% CI：30，58），豁免和全面审查之间无显著差异。然而，在减去研究和开发（R&D）委员会审查所需的时间后，豁免审查平均比全面审查短21天（95%CI：1，41）。IRB审查时间因IRB和审查级别而存在显著差异。很少有VA IRB达到60天IRB审查的共识小组目标。VA中豁免方案的审查时间意外延长，这可归因于研发委员会审查所需的时间。在IRB审查过程中前瞻性、常规收集关键时间点可以为IRB特定的减少VA IRB审查时间的举措提供信息。
Despite perceptions that IRBs delay research, little is known about how long it takes to secure IRB approval. We retrospectively quantified IRB review times at 10 large Veterans Affairs (VA) IRBs. We collected IRB records pertaining to a stratified random sample of research protocols drawn from 10 of the 26 largest VA IRBs. Two independent analysts abstracted dates from the IRB records, from which we calculated overall and incremental review times. We used multivariable linear regression to assess variation in total and incremental review times by IRB and review level (i.e., exempt, expedited, or full board) and to identify potential targets for efforts to improve the efficiency and uniformity of the IRB review process. In a sample of 277 protocols, the mean review time was 112 days (95%CI: 105,120). Compared to full-board reviews at IRB 1, average review times at IRBs 3, 8, 9 and 10 were 27 (95%CI: 6, 48), 37 (95%CI: 11, 63), 45 (95%CI: 20, 69) and 24 (95% CI: 2, 45) days shorter, and at IRB 6, times were 56 (95%CI: 28, 84) days longer. Across all IRBs, expedited reviews were 44 (95% CI: 30, 58) days shorter on average than were full-board reviews, with no significant difference between exempt and full-board reviews. However, after subtracting the time required for Research and Development (R&D) Committee review, exempt reviews were 21 (95%CI: 1, 41) days shorter on average than were full-board reviews. IRB review times differ significantly by IRB and review level. Few VA IRBs approach a consensus panel goal of 60 days for IRB review. The unexpectedly longer review times for exempt protocols in the VA can be attributed to time required for R&D Committee review. Prospective, routine collection of key time points in the IRB review process could inform IRB-specific initiatives for reducing VA IRB review times.
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