Consensus guidelines for central IRBs in the multicenter study setting

多中心研究环境中中央 IRB 的共识指南

基本信息

批准号：
9102180
负责人：
Stephan Ehrhardt
金额：
$ 36.45万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-19 至 2019-06-30
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): The prevailing model for ethical review of multicenter clinical trials is a distributed system of reviews conducted by the Institutional Review Board (IRB) of each institution engaged in the conduct of the trial. Conducting multiple reviews of a single protocol can delay the commencement of multicenter research and delay patient access to potentially beneficial treatments. Despite federal regulations that permit alternative review models to reduce duplication of effort by local IRBs, use of these alternatives, including use of a single IRB of record for a multicenter trial (i.e., central IRB), is a rare occurrence. In anticipaion of a major amendment to the regulatory framework for the review of multicenter trials and possibly more immediately, the transition to a system where a more centralized approach to IRB review of multicenter clinical trials is mandatory or strongly suggested by the FDA, NIH and other sponsors, there is an urgent need to identify operational procedures and guiding principles that are amenable to domestic institutions, policymakers, and other key stakeholders. The primary objective of this proposal is to establish priorities for the principles and practices of central IRBs in the multicenter study setting and propose evidence-based consensus guidance for institutions and investigators involved in central IRB review of a multicenter clinical trial ad for sponsors recommending use of central IRBs for multicenter trials. The specific aims of this project are to: 1) Describe the state of central IRB review of multicenter studies in the United States; 2) Conduct stakeholder focus groups to identify priorities for the formation and conduct of central IRBs and perceived ethical and regulatory barriers to uptake of central IRBs in the multicenter study setting; 3) Conduct a consensus survey of key stakeholders to prioritize the structure and responsibilities of a central IRB in the multicenter study setting; and 4) Develop and publish a consensus statement of principles and practices of central IRBs in the multicenter study setting. The project will include a systematic review of published and grey literature, the terms of existing agreements between institutions and IRBs choosing to undertake central IRB review, and the existing standard operating procedures of domestic central IRBs. The evidence from the systematic review will be integrated into a series of structured focus groups with 50 key stakeholders to allow further development of the responsibilities of central and local IRBs and achieve convergence of the topics of greatest importance. The findings of the focus groups will be incorporated into a 3 round modified Delphi consensus survey where over 1,000 stakeholders will be invited to prioritize the principles and practices of central IRBs. This is an integrative, evidence-based approach with the goal of establishing universal terminology, practices, and procedures that are amenable to US stakeholders engaged in developing or supporting a more streamlined approach to IRB review of multicenter research. The result of this rigorous, state of the art methodology is consensus guidance that will shape the development of a sustainable and replicable framework for central IRB review of multicenter clinical trials.

描述（由申请人提供）：多中心临床试验的道德审查的主要模型是由机构审查委员会（IRB）（IRB）进行的分布式审查系统，该系统对从事该试验的每个机构进行了审查。对单个方案进行多次审查可以延迟多中心研究的开始，并延迟患者获得潜在有益治疗的机会。尽管联邦法规可以允许替代审查模型减少当地IRB的重复，但使用这些替代方案，包括使用多中心试验（即中央IRB）记录的单个IRB是罕见的情况。为了预测对多中心试验审查的监管框架的重大修正案，并可能立即立即进行过渡，该系统的过渡强制性或强烈建议使用IRB对IRB进行更集中的IRB审查方法，或者由FDA，NIH和其他赞助者强烈建议，并且迫切需要进行操作的行程，并且是在国际运作过程中，并且是在国内统治的行动，并且是在国内统治的行动。利益相关者。该提案的主要目的是在多中心研究设置中为中央IRB的原理和实践确定优先级，并为参与中央IRB审查的机构和研究人员提出基于证据的共识指南，以审查赞助商，建议使用中央IRB用于多中心试验的赞助商。该项目的具体目的是：1）描述美国多中心研究中央IRB审查的状态； 2）进行利益相关者焦点小组，以确定在多中心研究环境中占中心IRB的中央IRB和伦理和监管障碍的优先级； 3）对主要利益相关者进行共识调查，以优先考虑中心研究环境中中央IRB的结构和责任； 4）在多中心研究环境中制定并发布了中央IRB的原则和实践的共识声明。该项目将包括对已发表和灰色文献的系统审查，选择进行中央IRB审查的机构和IRB之间的现有协议的条款以及国内中央IRB的现有标准操作程序。系统审查的证据将集成到一系列具有50个主要利益相关者的结构化焦点小组中，以进一步发展中央和地方IRB的职责，并实现最重要的主题的融合。焦点小组的发现将被纳入3轮修改的Delphi共识调查中，其中将邀请1,000多名利益相关者确定中央IRB的原则和实践的优先级。这是一个基于循证的综合方法的目的是建立通用术语，实践和程序，这些方法和程序可容纳我们从事开发或支持更简化的IRB审查多中心研究的方法。这种严格的，艺术方法论的结果是共识指导，它将塑造一个可持续且可复制的框架，用于对多中心临床试验进行中央IRB审查。