McWilliams Rita, Hebden Carl W, Gilpin Adele M K
Rutgers, The State University of New Jersey, ASB III, 3 Rutgers Plaza, New Brunswick, NJ 08901, USA.
Account Res. 2006 Jan-Mar;13(1):25-45. doi: 10.1080/08989620600588902.
As the volume and complexity of research have increased, the amount of time spent on Institutional Review Board (IRB) review has decreased. The complexity of research has expanded, requiring increasingly specialized knowledge to review it. Dilemma: Under the current system, increasing numbers of research studies requiring expertise in ethics, new technologies or diverse study designs place a substantial burden upon local IRBs and often result in substantial variability among their reviews. This lack of uniformity in the review process creates uneven human subjects' protection thus undermining the intent of the Common Rule.
To outline a scenario for expert centralized IRB review via implementation of a national virtual IRB review system overseen by the Office for Human Research Protections (OHRP).
The complicated ethical issues and science involved in much of current research warrant an expert review panel. Centralized review would enable expert review specific to the research at hand, ensure consistency in human subjects protection, reduce the burden on local IRBs, and may reduce time spent obtaining approval. A centralized virtual system would allow IRB members to remain at their institutions while providing unprecedented expert review through currently available technology, and make information regarding monitoring and adverse event reporting available online in real-time.
随着研究的数量和复杂性增加，机构审查委员会（IRB）审查所花费的时间减少了。研究的复杂性不断扩大，需要越来越专业的知识来进行审查。困境：在当前体系下，越来越多需要伦理、新技术或多样研究设计方面专业知识的研究给地方IRB带来了沉重负担，并且常常导致其审查结果存在很大差异。审查过程缺乏一致性导致对人类受试者的保护不均衡，从而破坏了《联邦法规汇编》中通用规则的意图。
概述一种通过实施由人类研究保护办公室（OHRP）监管的全国性虚拟IRB审查系统来进行专家集中式IRB审查的方案。
当前许多研究中涉及的复杂伦理问题和科学需要一个专家审查小组。集中审查能够针对手头的研究进行专门的专家审查，确保在保护人类受试者方面的一致性，减轻地方IRB的负担，并且可能减少获得批准所花费的时间。一个集中式虚拟系统将允许IRB成员留在各自机构，同时通过现有技术提供前所未有的专家审查，并使有关监测和不良事件报告的信息能够实时在线获取。
