Central IRB review of local context in emergency research: empirical ethics study

 描述（由申请人提供）：紧急研究中当地环境的中心IRB审查：经验伦理学研究使用经验伦理学来理解和优化当地环境的中心IRB审查：一种基于社区咨询的紧急研究模式，知情同意项目摘要/摘要机构审查委员会（IRB）除外对涉及人类受试者的临床研究进行监督，以保护参与者并确保研究行为符合伦理。当地IRB审查仅在自己的研究中心进行的研究，而中央机构审查委员会（CIRB）审查在许多研究中心进行的研究。无论审查是在当地还是集中进行，都必须考虑到研究所在地的任何当地环境。CIRB可能会对大型多中心临床试验提供更有效、公平和高效的审查，但CIRB是否能有效地考虑当地情况尚不清楚。地方背景审查在一种称为紧急研究知情同意例外的研究中尤为重要。在这类研究中，昏迷或其他危重病患者，如果他们的病情危及生命，并且实验性治疗只有在立即给予时才有效，则他们仍然可以参加试验。为了进行这种试验，研究人员还必须与社区协商，并公开有关研究的信息。然后，IRB必须将这些咨询的信息作为当地背景审查的一部分进行考虑。本项目的目的是探索、修订和测试由地方和中央IRB对这类研究进行社区咨询的地方背景审查的措施。我们将与关键利益相关者合作，确定目标和流程，使用这些数据制定可信度和可接受性等领域的指标，然后使用这些指标将当地IRB审查与模拟的CIRB审查进行比较，以进行真实的试验。该项目将在神经系统紧急情况治疗试验（NETT）网络和儿科紧急护理应用研究网络（PECARN）内进行。这些网络将作为一个“经验道德实验室”，在其中发展最佳做法。

 DESCRIPTION (provided by applicant): Central IRB review of local context in emergency research: empirical ethics study Using empirical ethics to understand and optimize Central IRB review of local context: a model based on community consultation in emergency research conducted with exception from informed consent Project Summary / Abstract Institutional Review Boards (IRBs) provide oversight to clinical research involving human subjects to protect participants and ensure ethical research conduct. Local IRBs review research performed just at their own site, while Central Institutional Review Boards (CIRBs) review research being conducted at many sites. Regardless of whether reviews are performed locally or centrally, they must take into account any local context specific to the site where the research will be performed. CIRBs may provide more effective, equitable, and efficient review of large multicenter clinical trials, but whether CIRBs can effectively consider local context is unknown. Local context review is especially important in a kind of research called exception from informed consent for emergency research. In this kind of research, patients who are comatose or otherwise critically ill and unable to consent for themselves may still participate in trials if thir condition is life-threatening and the experimental therapy is only effective if given right away. T perform this kind of trial, researchers must also consult with the community and publically disclose information about the study. Information about those consultations must then be considered by an IRB as part of local context review. The purpose of this project is to explore, revise, and test measures of local context review of community consultation for this type of research, by local and central IRBs. We will work with key stakeholders to identify goals and processes, use these data to develop measures in domains such as trustworthiness and acceptability, and then use these measures to compare local IRB reviews to those of a simulated CIRB for a real trial. This project will be conducted within the Neurological Emergencies Treatment Trials (NETT) network and the Pediatric Emergency Care Applied Research Network (PECARN). These networks will serve as an "empirical ethics lab" in which best practices are developed.