Tzeng Dong-Sheng, Wu Yi-Chang, Hsu Jane-Yi
Kaohsiung Armed Forces General Hospital, No. 2, Chung-Cheng 1st Road, Kaohsiung City, Taiwan.
Tri-Service General Hospital Beitou Branch, Taipei City, Taiwan.
BMC Med Ethics. 2015 Aug 27;16:57. doi: 10.1186/s12910-015-0050-8.
To investigate the factors related to approval after review by an Institutional Review Board (IRB), the structure equation model was used to analyze the latent variables 'investigators', 'vulnerability' and 'review process' for 221 proposals submitted to our IRB.
The vulnerability factor included vulnerable cases, and studies that involved drug tests and genetic analyses. The principal investigator (PI) factor included the license level of the PI and whether they belonged to our institution. The review factor included administration time, total review time, and revision frequency. The revision frequency and total review time influenced the efficiency of review.
The latent variable of reviewing was the most important factor mediating the PIs and vulnerability to IRB review approval. The local PIs moderated with genetic study and revision frequency had an impact on the review process and mediated non-approval.
Better guidance of the investigators and reviewers might improve the efficiency with which IRBs function.
为了调查与机构审查委员会（IRB）审查后批准相关的因素，采用结构方程模型分析了提交给我们IRB的221份提案的潜在变量“研究者”、“脆弱性”和“审查过程”。
脆弱性因素包括脆弱案例以及涉及药物测试和基因分析的研究。主要研究者（PI）因素包括PI的执照级别以及他们是否隶属于我们的机构。审查因素包括管理时间、总审查时间和修订频率。修订频率和总审查时间影响审查效率。
审查的潜在变量是介导PI与IRB审查批准的脆弱性之间关系的最重要因素。当地PI与基因研究的调节作用以及修订频率对审查过程有影响并介导不批准。
对研究者和审查者进行更好的指导可能会提高IRB的运作效率。
