A Measure of Effectiveness Is Key to the Success of sIRB Policy.
A Measure of Effectiveness Is Key to the Success of sIRB Policy.
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衡量有效性是 sIRB 政策成功的关键。
DOI：
10.1080/15265161.2017.1328537
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发表时间：
2017
期刊：
影响因子：
--
通讯作者：
Ervin,AnnMargret
中科院分区：
文献类型：
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作者：
Taylor,HollyA;Ervin,AnnMargret
在她的文章“最终规则：当橡胶遇到道路”中，O 'Rourke博士总结了美国机构依赖单一机构审查委员会（sIRB）审查多中心研究（合作研究）的任务，并引用了与实施政策相关的具体挑战（O 'Rourke 2017）。预期单个IRB模型将比多个IRB对同一方案的审查更有效（联邦政策2017；国家卫生研究院[NIH] 2016； Klitzman, Pivovarova, and Lidz 2017）。效率似乎是一个合理的预期，但我们没有足够的证据来评估sIRB系统是否比当前的分散系统更有效（Ervin, Taylor, and Ehrhardt 2016; Klitzman, Pivovarova, and Lidz 2017）。正如修订后的共同规则序言中所指出的，目前尚不清楚本地IRB审查是否单独导致当前系统效率低下，因为尽管有sIRB政策，其他监管或机构审查的行为仍将继续，也可能推迟研究的开始（联邦政策2017,7209）。我们也不知道效率（即获得某种结果所需的资源数量）是否是审查和监督人类受试者研究的最具信息量的衡量标准。虽然IRB审查提案所需的时间或人类研究保护计划（HRPP）批准协议所需的时间是评估IRB流程效率最常用的变量（Abbott and Grady 2011），但尚不清楚它是否是唯一感兴趣的变量或IRB审查有效性的良好代理。IRB审查的实质目标是确保拟议的研究对参与者的风险最小化，并在研究完成后获得最大的利益（National Commission 1979; Taylor 2007）。研究的好处可能会累积到参与者身上，但至少应该促进知识的发展（即造福社会）。sIRB程序的反对者认为，由多个IRB进行审查可以最大限度地提高所有潜在风险被识别和最小化的可能性，因为没有任何一个IRB可以被期望具有“IRB集体的覆盖范围和知识广度”（NIH公开评论）。虽然可能存在审查的最大数量，超过该数量多个irb的价值可能会减少，但它可能大于一个。一些反对sIRB政策的人还认为，只有当地的irb审查才能充分解决可能影响研究参与者福利的当地考虑因素（人类研究保护秘书咨询委员会[SACHRP] 2011； NIH 2016）。虽然sIRB可以也将征求本地环境信息，但目前没有关于收集信息类型以及如何将本地环境纳入sIRB审查过程的指导。目前还没有标准的措施来完成IRB/sIRB审查过程的有效性（Ervin, Taylor, Meinert, and Ehrhardt 2015）。这一措施将有助于评估sIRB政策的实施是否成功。由于缺乏标准措施来评估IRB/sIRB流程的有效性，或评估和/或比较有兴趣承担sIRB角色的人类研究保护计划（HRPP）的质量，HRPP认证等代理措施得到了推广。人类研究保护计划认证协会（AAHRPP）的认证已成为该领域的标准。人类研究保护办公室（OHRP）也有质量改进…
In her article “The Final Rule: When the Rubber Meets the Road” Dr. O’Rourke summarizes the mandate that US institutions rely on a single institutional review board (sIRB) for the review of multicenter studies (cooperative research), and cites specific challenges associated with implementation of the policy (O’Rourke 2017). The expectation is that the single IRB model will be more efficient than multiple IRB reviews of the same protocol (Federal Policy 2017; National Institutes of Health [NIH] 2016; Klitzman, Pivovarova, and Lidz 2017). Efficiency seems to be a reasonable expectation, but we do not have sufficient evidence to assess whether the sIRB system is more efficient than the current decentralized system (Ervin, Taylor, and Ehrhardt 2016; Klitzman, Pivovarova, and Lidz 2017). As noted in the preamble to the revised Common Rule, it is not known whether local IRB review alone is responsible for the inefficiencies in the current system, as the conduct of other regulatory or institutional reviews, which will continue despite the sIRB policy, may also delay commencement of research (Federal Policy 2017, 7209). We also don’t know whether efficiency (ie, the amount of resources required to obtain a certain result) is the most informative measure for the review and oversight of human subjects research. While the amount of time a proposal is under review by an IRB or the time it takes for the Human Research Protections Program (HRPP) to approve the protocol is the variable most often measured to assess the efficiency of the IRB process (Abbott and Grady 2011), it is not clear that it is the only variable of interest or a good proxy for the effectiveness of IRB review. The substantive goal of IRB review is to ensure that the proposed research minimizes risks to participants and maximizes the benefits to be gained by the completion of the research (National Commission 1979; Taylor 2007). The benefits of research may accrue to participants, but ought to at least advance knowledge (ie, benefit society). Opponents of the sIRB process suggest that review by multiple IRBs maximizes the likelihood that all potential risks will be identified and minimized as no single IRB can be expected to have the “coverage and breadth of knowledge as [with] a collective body of IRBs”(NIH public comments). While there may be a maximum number of reviews beyond which the value of multiple IRBs may diminish, it is likely greater than one. Some opponents of the sIRB policy also believe that only local IRBs reviews can adequately address local considerations that may affect the welfare of study participants (Secretary’s Advisory Committee on Human Research Protections [SACHRP] 2011; NIH 2016). While local context information can and will be solicited by the sIRB, currently there is no guidance regarding the type of information to collect and how local context should be incorporated into the sIRB review process. There is currently no standard measure by which the effectiveness of the IRB/sIRB review process is accomplished (Ervin, Taylor, Meinert, and Ehrhardt 2015). Such a measure would be useful to assess whether the implementation of the sIRB policy is a success.In absence of standard measures to assess the effectiveness of the IRB/sIRB process or to assess and/or compare the quality of a Human Research Protection Program (HRPP) interested in taking on the role of sIRB, proxy measures such as HRPP accreditation have been promoted. Accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) has become the standard in the field. The Office for Human Research Protections (OHRP) also has a quality improvement …