Central IRBs: Enhanced Protections for Human Research Participants?

描述（由申请人提供）：尽管机构审查委员会（IRB）最初旨在反映当地价值观和知识;但它们因不适合大型多中心研究而受到广泛批评。一个拟议的解决方案是增加使用中央IRB（C-IRB），这将管理所有站点的人类受试者保护。本研究将使用创新方法，并建立在研究者对IRB的先前研究的基础上，以描述C-IRB如何审查多中心项目，以及这些审查与单中心审查和当地IRB审查多中心项目的不同之处。本研究的结果旨在帮助（1）定义CIRB开展过程中涉及的原则和实践，（2）了解不同的工具或程序是否有助于最大限度地提高CIRB的有效性，以及（3）描述IRB作为C-IRB时应考虑的任何伦理和后勤问题。这个建议结合了我们在两个不同的地方IRB的研究中使用的方法来描述中央IRB的决策过程。这些方法将包括与10个不同的中心IRB相关的22个不同IRB小组的音频记录和估计249次审查，以及与管理人员、IRB主席、审查人员和工作人员的半结构化访谈。我们已经开发了编码和处理这类数据的系统程序，以便我们可以对数据进行系统的定性和复杂的定量分析。它将使我们能够描述中央IRB的组织和决策。此外，我们还将探讨确定中央IRB与当地IRB在审查需要全面审查的方案时所考虑的主题的比较方法。我们对当地IRB的研究使我们具有独特的资格，并准备研究这种创新的IRB审查。

DESCRIPTION (provided by applicant): Although Institutional review boards (IRB) were originally intended to reflect local values and knowledge; they have been widely criticized as inappropriate for large multi-site studies. One proposed solution is increased use of central IRBs (C-IRBs), which would manage human subject protection for all of the sites. This study will use innovative methods and built on prior research on IRBs by the investigators to describe how C-IRBs review multi-site projects, and how these reviews differ from single site reviews and the reviews of multi-site projects by local IRBs. The results of this study are intended to help (1) define the principles and practices involved in the conduct of CIRBs, (2) understand whether different tools or procedures will help to maximize the effectiveness of CIRBs and (3) describe any ethical and logistical issues that should be taken into account when IRBs act as C-IRBs. This proposal combines methods that we used in two different studies of local IRBs to describe central IRBs decision-making processes. These methods will include audio-recording of and estimated 249 reviews at 22 different IRB panels associated with 10 different central IRBs and semi-structured interviews with administrators, IRB chairs, reviewers, and staff members. We have developed systematic procedures for coding and processing this type of data so that we can do both systematic qualitative and sophisticated quantitative, analyses of the data. It will allow us to describe the organization and decision making of central IRBs. In addition, we will explore approaches for determining how central IRBs compare to local IRBs in the topics considered during the reviews of protocols requiring full board review. Our research on local IRBs has made us uniquely qualified and ready to study this innovation IRB review.