Looking into the institutional review board: Observations from both sides of the table
Looking into the institutional review board: Observations from both sides of the table
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DOI：
10.1093/jn/135.4.921
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发表时间：
2005-04-01
影响因子：
4.2
通讯作者：
Burke, GS
中科院分区：
文献类型：
--
作者：
Burke, GS
机构审查委员会（IRB）的审查提供了委员会与研究和研究对象的距离所提供的视角的好处。与此同时，研究对象在地理、社会经济、认知、语言和文化方面的距离可能会破坏视角的积极作用。此外，IRB和调查人员之间的距离，主要是态度和沟通的结果，可能会延长审查过程，并可能掩盖其信息。IRB与研究者之间的紧张关系通常是由于IRB在不同机构应用联邦法规时的差异，以及研究者缺乏经验、沟通问题和难以预测受试者的需求。IRB的人口统计学和文化、影响IRB-研究者关系的态度以及机构支持的充分性是造成变异性的原因。这些因素对审查决定和人类受试者保护系统的性能的影响在很大程度上没有研究。IRB认证运动促使机构审查其整体研究保护系统，并承诺采取更加协作的方法，IRB和研究人员接受他们的共同责任，以满足受试者的需求并提高研究质量。
Institutional review board (IRB) reviews offer the benefit of perspective afforded by the board's distance from the research and the research subjects. At the same time, distance from research subjects that is geographic, socioeconomic, cognitive, linguistic, and cultural can undermine the positive role of perspective. In addition, distance between IRB and investigators, largely a result of attitudes and communication, can prolong the review process and can obscure its message. The tension that often characterizes IRB-investigator relationships is due, in part, to variability in the application of federal regulations by IRBs across institutions and, on the part of investigators, inexperience, communication problems, and difficulties in anticipating the needs of their subjects. Contributing to the variability are the demographics and the culture of the IRB, attitudes that influence IRB-investigator relationships, and the adequacy of support from the institution. The effects of these factors on review decisions and on the performance of the human subjects protection system are largely unstudied. The movement for IRB accreditation is causing institutions to examine their overall research protection system and promises a more collaborative approach, where IRB and investigators accept their common charge to meet the needs of subjects and to improve the quality of research.