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

 描述(由申请人提供)：紧急研究中对当地背景的中央IRB审查：使用经验伦理来理解和优化中央IRB对当地背景的审查：基于社区协商进行的紧急研究的模式项目摘要/抽象机构审查委员会(IRBs)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进行符合伦理的研究。地方IRBs只在自己的网站上审查研究，而中央机构审查委员会(CIRBs)审查在许多地点进行的研究。无论审查是在当地进行还是集中进行，都必须考虑到将进行研究的地点所特有的任何当地背景。CIRBs可能会为大型多中心临床试验提供更有效、公平和高效的审查，但CIRBs是否能有效地考虑当地情况尚不清楚。在一种被称为紧急研究知情同意例外的研究中，本地背景审查尤其重要。在这种研究中，昏迷或其他危重疾病的患者，如果他们的病情危及生命，他们仍然可以参加试验，而且只有在立即给予实验性治疗的情况下，才能有效。如果不进行这种试验，研究人员还必须咨询社区并公开披露有关研究的信息。然后，作为当地背景审查的一部分，IRB必须考虑有关这些磋商的信息。本项目的目的是探索、修订和测试地方和中央研究所为这类研究进行社区磋商的地方背景审查措施。我们将与主要利益相关者合作确定目标和流程，使用这些数据来制定可信度和可接受性等领域的衡量标准，然后使用这些衡量标准将本地IRB审查与真实试验的模拟CIRB审查进行比较。该项目将在神经紧急治疗试验(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“经验伦理实验室”，在其中制定最佳做法。

 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.