How local IRBs view central IRBs in the US

BMC Medical Ethics

Research Article

Robert Klitzman¹ 

[1] Department of Psychiatry, Columbia University, 1051 Riverside Drive #15, New York, NY, USA;

关键词: Local Knowledge;    Research Integrity;    Local IRBs;    Local Review;    Centralize IRBs;   

DOI  :  10.1186/1472-6939-12-13

 received in 2011-02-10, accepted in 2011-06-23,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundCentralization 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.MethodsI 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.ResultsThese 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.ConclusionsThese 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.

【 授权许可】

CC BY   
© Klitzman; licensee BioMed Central Ltd. 2011