Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.
Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.
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DOI：
10.1080/23294515.2018.1510437
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发表时间：
2018-07
影响因子：
--
通讯作者：
Klitzman RL
中科院分区：
文献类型：
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作者：
Lidz CW;Pivovarova E;Appelbaum P;Stiles DF;Murray A;Klitzman RL
美国国立卫生研究院(NIH)关于使用单一机构审查委员会(SIRB)进行多站点研究的新政策主要是为了简化和加快复杂的多站点临床试验的审查。然而，加快审查需要克服一些障碍。也许最大的障碍是在参与地点之间制定信赖协定所需的时间和努力。我们对SIRB人员进行了102次半结构化访谈，其中包括董事、主席、审查员和工作人员，他们来自20个多站点研究的SIRBs，其中包括6个商业/独立SIRB，10个大学学者和4个联邦SIRB。几乎无一例外，受访者一致认为，信赖协议复杂、难以制定且耗时。依赖站点的一个主要问题是，不同的协议为依赖站点指定了不同的责任。对于这些问题是否会随着内部评级机构的工作人员和管理人员变得更有经验而得到解决，人们的态度存在分歧。然而，显然必须简化制定信赖协定的过程。联邦政府协助至少对信赖协定的某些部分进行标准化，可能会减少所涉及的困难。
The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.