Central Institutional Review Board

本合同的目的是为美国国家癌症研究所（NCI）癌症治疗评估计划（CTEP）中央机构审查委员会（CIRB）倡议提供行政、技术和监管支持。CIRB倡议是CTEP努力简化临床试验系统的关键部分，最初建议在阿米蒂奇报告的临床试验实施计划中，并于2005年被临床试验工作组（CTWG）接受。 CIRB成立于2001年，是一个独立的审查委员会，其任务是在研究获得CTEP最终批准之前，为保护人类受试者的合作组临床试验提供全面的委员会审查。这一中央伦理审查过程符合OHRP法规，该法规要求这些研究接受全体委员会的IRB审查，从而减轻了当地IRB与进行自己的全体委员会审查相关的责任和工作。CIRB倡议由两个中心IRB组成：一个审查III期和选定的II期试验，由成人合作组协调;另一个审查试验，由儿科合作组协调。 通过安全网站向研究者和IRB提供CIRB审查。NCI与OHRP合作，制定了“便利审查”流程，该流程包括指定IRB主席或小组委员会的当地IRB，以审查CIRB的会议记录和与合作组临床试验相关的主要审查员的意见，而不是在当地IRB召开全体董事会会议。如果主席或小组委员会决定接受CIRB对研究相关文件的审查，则主席或小组委员会确定符合当地背景要求。当地背景要求包括遵守当地法律、文化敏感性和/或当地IRB要求，例如在知情同意书中使用机构信笺，并在知情同意书中包括当地联系信息。 CIRB与当地委员会的合作伙伴关系提供了对试验的全面审查，当地委员会提供了IRB主席或小组委员会对当地情况的审查，节省了当地IRB成员以及研究者和研究人员的时间和精力。除了节省时间和精力外，使用协助式审查使当地研究中心能够比使用传统的全面委员会审查更快地启动合作组试验。此外，与必须审查与所有学科相关的临床试验的当地IRB相比，CIRB可以提供更多的专家审查，因为它由专门从事肿瘤学的成员组成。

The purpose of this contract is to provide administrative, technical and regulatory support to the National Cancer Institute's (NCI's) Cancer Therapy Evaluation Program's (CTEP's) Central Institutional Review Board (CIRB) Initiative. The CIRB Initiative is a key part of the CTEP's efforts to streamline the clinical trials system as originally recommended in the Armitage Report's Clinical Trials Implementation Plan and embraced in 2005 by the Clinical Trials Working Group (CTWG). The CIRB was established in 2001 as an independent review Board tasked with providing full Board review of Cooperative Group clinical trials for human subject¿s protections before the study receives final approval from CTEP. This process of a central ethics review results in compliance with OHRP regulations that require these studies to receive IRB review by a full Board thus relieving local IRBs from the responsibility and effort related to conducting their own full Board review. The CIRB Initiative consists of two central IRBs: one reviewing phase 3 and selected phase 2 trials coordinated by the adult Cooperative Groups and the second reviewing trials coordinated by the pediatric Cooperative Group. The CIRB reviews are made available to investigators and IRBs through a secured website. The NCI, in collaboration with OHRP, developed the process of ¿facilitated review' which consists of a local IRB designating the IRB Chair or a subcommittee to review the CIRB's minutes and primary reviewer's comments related to a Cooperative Group clinical trial in lieu of convening a full board meeting at the local IRB. If the Chair or subcommittee decides to accept the CIRB's review of the study-related documents, the Chair or subcommittee determines that local context requirements are met. Local context requirements include compliance with local laws, cultural sensitivities, and/or local IRB requirements such as using institutional letterhead for the informed consent document and including local contact information in the consent document. The partnership of the CIRB providing full Board review of the trial in conjunction with the local board providing review for local context by the IRB Chair or subcommittee conserves local IRB members' time and effort as well as that of investigators and research staff. In addition to economies of time and effort, using facilitated review enables a local site to open a Cooperative Group trial more quickly than when using traditional full Board review. Also, it is possible that the CIRB can provide a more expert review as it is comprised of members with expertise dedicated to oncology compared to a local IRB which must review clinical trials pertaining to all disciplines.