Nichols Ceilidh, Kunkel Lynn E, Baker Robin, Jelstrom Eve, Addis Megan, Hoffman Kim A, McCarty Dennis, Korthuis P Todd
Oregon Health & Science University-Portland State University School of Public Health Oregon Health & Science University, 3181 SW Sam Jackson Park Rd., CSB669, Portland, OR 97239-3088, USA.
The Emmes Corporation, Rockville, MD, 401 N Washington St # 700, Rockville, MD 20850, USA.
Contemp Clin Trials Commun. 2019 Jan 7;14:100319. doi: 10.1016/j.conctc.2019.100319. eCollection 2019 Jun.
Recent NIH policy stipulates that multi-site studies must use a single or IRB (Institutional Review Board) in order to streamline the review process while maintaining standards for human subjects protection. The Western States Node of the Clinical Trials Network (CTN) used a single IRB for protocol CTN-0067, a clinical trial testing the use of an opioid antagonist (extended-release naltrexone) versus opioid agonists (buprenorphine or methadone) for opioid use disorders among individuals living with HIV. This case study discusses the processes and challenges associated with use of a single IRB. These lessons are also informed by other single IRB experiences within the CTN. The intention of the NIH single IRB policy is to facilitate efficient IRB processes. Advanced planning and transparent communication, however, are critical to avoid stalling IRB approval and protocol implementation. Research teams need to account for local IRB willingness to cede to a single IRB and understand the variations in interpretations of abbreviated reviews. In order to facilitate the effective use of single IRBs, recommendations include assigning staff at each study site for IRB submission coordination and interaction with the lead site IRB staff, training investigators and key regulatory staff on expectations for working with single IRBs, dedicating a regulatory specialist at the lead site to manage the process, developing a communication plan, and supporting the development of strong working relationships with local regulatory staff and the single IRB. The CTN experiences with single IRBs may provide insights for other investigators.
美国国立卫生研究院（NIH）最近的政策规定，多中心研究必须使用单一的机构审查委员会（IRB），以便在维持人体受试者保护标准的同时简化审查流程。临床试验网络（CTN）西部各州节点在协议CTN-0067中使用了单一的IRB，该临床试验测试了阿片类拮抗剂（长效纳曲酮）与阿片类激动剂（丁丙诺啡或美沙酮）在HIV感染者阿片类药物使用障碍治疗中的效果。本案例研究讨论了与使用单一IRB相关的流程和挑战。这些经验教训也借鉴了CTN内其他单一IRB的经验。NIH单一IRB政策的目的是促进高效的IRB流程。然而，提前规划和透明沟通对于避免IRB批准和协议实施的拖延至关重要。研究团队需要考虑当地IRB是否愿意让渡给单一IRB，并了解对简化审查的不同解释。为了促进单一IRB的有效使用，建议包括在每个研究地点指定工作人员负责IRB提交协调以及与牵头地点的IRB工作人员进行互动，对研究人员和关键监管人员进行关于与单一IRB合作预期的培训，在牵头地点指定一名监管专家来管理流程，制定沟通计划，并支持与当地监管人员和单一IRB建立良好的工作关系。CTN在单一IRB方面的经验可能为其他研究人员提供见解。
