Central Institutional Review Board

这份合同的目的是为国家癌症研究所(NCI)癌症治疗评估计划(CTEP)的中央机构审查委员会(CIRB)倡议提供行政、技术和监管支持。CIRB计划是CTEP简化临床试验系统的努力的关键部分，该计划最初在Armitage Report的临床试验实施计划中建议，并于2005年得到临床试验工作组(CTWG)的支持。 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的最终批准之前，对合作集团针对人类受试者S保护的临床试验进行全董事会审查。这一中央道德审查过程符合OHRP条例，该条例要求这些研究接受IRB全体董事会的审查，从而使地方IRBs免除了与进行其自身全体董事会审查有关的责任和努力。CIRB倡议由两个中心IRBs组成：一个由成人合作小组协调的审查第3阶段和选定的第2阶段试验，以及由儿科合作小组协调的第二个审查试验。 CIRB的审查通过一个安全网站向调查人员和IRBs提供。NCI与OHRP合作，制定了“促进审查”的程序，其中包括由一个地方IRB指定IRB主席或一个小组委员会来审查CIRB的会议记录和主要审查员对合作小组临床试验的评论，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对与研究有关的文件的审查，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，例如在知情同意文件中使用机构信头，并在同意文件中包括当地联系信息。 CIRB与当地委员会一起提供对试验的全面审查，由IRB主席或小组委员会根据当地情况进行审查，这一合作关系节省了当地IRB成员以及调查人员和研究人员的时间和精力。除了节省时间和精力外，使用促进审查使当地网站能够比使用传统的全董事会审查更快地启动合作小组试验。此外，CIRB可能会提供更专业的审查，因为它由具有肿瘤学专业知识的成员组成，而地方IRB必须审查与所有学科有关的临床试验。

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.