Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey.
Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey.
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DOI：
10.1136/tsaco-2018-000176
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发表时间：
2018-01-01
影响因子：
2
通讯作者：
Pascual, Jose L
中科院分区：
文献类型：
--
作者：
Nahmias, Jeffry;Grigorian, Areg;Pascual, Jose L
对人类受试者研究的监督从一开始就有了很大的变化。然而，以前的研究发现，机构审查委员会(IRB)对所需审查的类型以及是否需要知情同意的确定缺乏一致性，特别是对于危害风险最小的前瞻性观察性研究。我们假设，IRB对审查的类型和知情同意的必要性的要求存在显著的机构间差异，特别是对于不使用血液/组织的前瞻性观察性试验。我们还试图描述调查人员和IRB成员对审查类型和同意的需要的态度。向东部创伤外科协会(EAST)和IRB成员发送了一份关于IRB审查和知情同意要求的电子调查问卷。我们进行了描述性分析以及费舍尔的精确检验，以确定EAST和IRB成员之间的反应差异。来自113家机构的East会员的回应率为13.5%，而来自14家机构的方便样本IRB成员的回应率为64.4%。使用患者识别符进行回顾性研究的完整IRB审查要求没有IRB成员报告，而EAST成员的这一比例为13.1%(p=0.05)。至于不采集血液/组织的前瞻性观察性试验，48.1%的EAST成员报告他们的机构需要进行全面的IRB审查，而IRB成员的这一比例为9.5%(p=0.01)。对于血液/组织采集的前瞻性观察性试验，80%的EAST成员表示需要提交IRB的全面审查，而IRB成员中只有13.6%(p
Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators' and IRB members' attitudes toward the type of review and need for consent. Eastern Association for the Surgery of Trauma (EAST) and IRB members were sent an electronic survey on IRB review and informed consent requirement. We performed descriptive analyses as well as Fisher's exact test to determine differences between EAST and IRB members' responses. The response rate for EAST members from 113 institutions was 13.5%, whereas a convenience sample of IRB members from 14 institutions had a response rate of 64.4%. Requirement for full IRB review for retrospective studies using patient identifiers was reported by zero IRB member compared with 13.1% of EAST members (p=0.05). Regarding prospective observational trials without blood/tissue collection, 48.1% of EAST members reported their institutions required a full IRB review compared with 9.5% of IRB members (p=0.01). For prospective observational trials with blood/tissue collection, 80% of EAST members indicated requirement to submit a full IRB review compared with only 13.6% of IRB members (p