How local IRBs view central IRBs in the US.
How local IRBs view central IRBs in the US.
复制标题
DOI：
10.1186/1472-6939-12-13
复制
发表时间：
2011-06-23
影响因子：
2.7
通讯作者：
Klitzman R
中科院分区：
文献类型：
--
作者：
Klitzman R
在美国和其他地方，IRB 审查的集中化程度不断提高，但仍然存在许多问题。在美国，已经建立了一些集中式IRB（CIRB），但它们如何运作以及如何运作仍不清楚。我联系了 60 个 IRB（在 NIH 资助的前 240 个机构名单中占第四个），并采访了 34 个机构的领导（回复率 = 55%）以及另外 12 名成员和管理人员。这些受访者经常与 CIRB 互动，但支持当地审查，并提供了各自的优点和缺点。受访者认为，地方IRB可以提供受试者和PI的“本地知识”，并与PI进行“路边咨询”，促进相互信任。 PI 可以更充分和非正式地与当地 IRB 进行有效的互动。 IRB 还感到有额外的责任来保护“他们自己的”受试者。受访者提到了 CIRB 的一些优点（例如，CIRB 可以简化审查），尽管这种情况很少且很粗略。总体而言，受访者对 CIRB 持谨慎态度，他们认为 CIRB 的质量差异很大，具体取决于成员是谁。地方IRB 和中央IRB 似乎都产生了意想不到的后果。例如，IRB 之间出现的差异似乎反映了机构文化和历史以及主席和/或直言不讳的成员的个性方面的差异，而不是当地社区价值观本身的差异，因此似乎不是法规的意图。尽管一些批评家将 CIRB 视为许多 IRB 问题的解决方案，但仍出现了关键的权衡和不确定性。这些数据对未来的政策和研究具有重要影响。争论需要超越简单的关于 CIRB 是否应该取代地方 IRB 的二元讨论，而是要研究不同模式如何运作以及在何种程度上运作，以及每种模式的相对优势和劣势是什么。尽管一些批评者将 CIRB 视为万能药，但某些问题似乎可能会继续存在。需要仔细考虑地方IRB的优势是否大于由此产生的问题，以及是否可以开发出一个既提供这些好处又避免地方IRB缺点的系统。
Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. These interviewees had often interacted with CIRBs, but supported local reviews, and offered advantages and disadvantages of each. Interviewees argued that local IRBs can provide "local knowledge" of subjects and PIs, and "curbside consults" with PIs, facilitating mutual trust. PIs may interact more fully and informally, and hence effectively with local IRBs. IRBs also felt additional responsibility to protect "their own" subjects. Respondents mentioned a few advantages of CIRBs (e.g., CIRBs may streamline reviews), though far more rarely and cursorily. Overall, interviewees were wary of CIRBs, which they saw as varying widely in quality, depending on who happened to be members. Both local and centralized IRBs appear to have unintended consequences. For instance, discrepancies arose between IRBs that appeared to reflect differences in institutional culture and history, and personalities of chairs and/or vocal members, more than in local community values per se, and thus do not seem to be the intent of the regulations. While some critics see CIRBs as solutions to many IRB problems, critical tradeoffs and uncertainties emerge. These data have critical implications for future policy and research. Debates need to evolve beyond simply a binary discussion of whether CIRBs should replace local IRBs, to examine how and to what degree different models might operate, and what the relative advantages and disadvantages of each are. While some critics see CIRBs as panaceas, certain problems appear likely to continue. Careful consideration needs to be given to whether the advantages of local IRBs outweigh the problems that result, and whether a system can be developed that provides these benefits, while avoiding the disadvantages of local IRBs.
登录
查看更多内容
影响因子：
45.3
作者：
Wagner, Todd H.;Murray, Christine;Abrams, Jeffrey
通讯作者：
Abrams, Jeffrey
影响因子：
5.4
作者：
Klitzman, RL;Daya, S
通讯作者：
Daya, S
影响因子：
7.4
作者：
Loh, ED;Meyer, RE
通讯作者：
Meyer, RE
影响因子：
3.5
作者：
Klitzman, Robert
通讯作者：
Klitzman, Robert
影响因子：
4.1
作者：
Ahmed, AH;Nicholson, KG
通讯作者：
Nicholson, KG