Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.
Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews.
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DOI：
10.1177/1556264620956795
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Hall DE
中科院分区：
文献类型：
--
作者：
Tsan MF;Ling B;Feske U;Zickmund S;Stone R;Sonel A;Arnold RM;Fine M;Hall DE
机构审查委员会(IRBs)在多大程度上遵守《共同规则》的初始议定书审查标准尚未得到系统评估。我们比较了使用人类研究保护办公室(OHRP)人类受试者法规决策表确定的审查水平，这些规则是由IRBs批准的313项方案的。由全体董事会审查的140项方案与OHRP标准审查的水平之间有97.8%的符合率。同样，在使用快速审查程序和OHRP标准进行审查的113个方案之间有93.8%的一致性。然而，只有75%的人同意豁免议定书。具体地说，在60项豁免议定书中，有10项(16.7%)被发现需要IRB审查，即6项议定书需要快速审查，4项议定书需要全面审查。未经IRB事先批准而进行非豁免研究构成严重违反规定。我们的数据表明，豁免协议需要更多的审查。
How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, i.e., 6 protocols requiring expedited review and 4 protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.
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DOI：
10.1016/j.jss.2016.06.004
发表时间：
2016-08
期刊：
The Journal of surgical research
影响因子：
--
作者：
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影响因子：
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发表时间：
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影响因子：
1.3
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通讯作者：
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