Community VOICES (3):Community VOICES on informed consent in emergency situation

描述(由申请人提供)：知情同意是伦理研究的核心，但在急诊医学、创伤和危重护理研究中往往无法获得。当现有的治疗方法不令人满意，参与可能带来直接好处时，联邦法规21 CFR 50.24允许知情同意(EFIC)的例外，允许在无法同意的情况下登记危及生命的受试者。满足EFIC研究的额外要求，包括“社区咨询”(CC)和“公开披露”(PD)，是困难、昂贵的，而且往往不成功，因为没有足够的数据来指导调查人员和机构审查委员会(IRB)执行CC和PD的最佳做法，缺乏对适当社区的定义，以及缺乏衡量不同CC方法成功与否的适当衡量标准。为了弥补这些差距，位于西奈山的非常合格的社区声音研究团队与多个地点合作，在NHLBI资助的复苏结果联盟(ROC)和NINDS资助的神经紧急情况治疗试验网络(NETT)内进行EFIC研究。这项研究将是第一次使用多个EFIC研究和地点，前瞻性和系统地观察CC活动、研究前的公开披露、“选择退出”机制、参与者/代理人的登记后通知和研究后的公开披露；2)使用Voice 2中制定的明确标准(目前的应用是竞争性的更新)，评估CC在五个Voice领域的各种策略的有效性：可行性、参与者组成、通信质量、参与者感知和调查者/IRB感知；3)收集IRBs在审查和监督EFIC研究时如何执行第50.24部分的详细定性和定量数据。这项研究将在跨学科的概念框架中使用融合的混合方法设计，同时使用定量和定性方法，并对两种类型的数据进行合并分析。这些发现将通过为满足EFIC研究的伦理和监管要求提供实用指导，从而改善EFIC对一系列危及生命的疾病的新疗法的临床试验的实施。

DESCRIPTION (provided by applicant): Informed consent is central to ethical research but often impossible to obtain in emergency medicine, trauma, and critical care research. When available treatments are unsatisfactory and participation may offer direct benefit, federal regulations 21 CFR 50.24 allow an exception from informed consent (EFIC) to permit enrolling subjects in a life-threatening situation who are unable to consent. Fulfilling the additional requirements for EFIC studies, including "community consultation" (CC) and "public disclosure" (PD), is difficult, expensive, and often unsuccessful because of the inadequacy of data to guide investigators and institutional review boards (IRB) on best practices for performing CC and PD, the absence of a definition of the appropriate community, and the lack of appropriate metrics to gauge the success of different CC methods. To address these gaps, the exceptionally qualified Community VOICES study team at Mount Sinai has partnered with multiple sites conducting EFIC studies within the NHLBI-funded Resuscitation Outcomes Consortium (ROC), and the NINDS-funded Neurological Emergencies Treatment Trials Network (NETT). This study will be the first to 1) prospectively and systematically, using multiple EFIC studies and sites, observe CC activities, pre-study public disclosure, "opt-out" mechanisms, post-enrollment notification of participants/surrogates, and post-study public disclosure; 2) use explicit criteria developed in VOICES 2, (of which the current application is a competing renewal), to assess the effectiveness of various strategies for CC with respect to the five VOICES domains: feasibility, participant composition, quality of communication, participant perceptions, and investigator/IRB perceptions; and 3) gather detailed qualitative and quantitative data on how IRBs implement Part 50.24 in their review and oversight of EFIC studies. The research will use a convergent mixed-methods design with concurrent use of quantitative and qualitative methods in a trans-disciplinary conceptual framework with merged analysis of both types of data. The findings will allow improved implementation of EFIC clinical trials on new treatments for a range of life-threatening conditions by providing practical guidance on meeting the ethical and regulatory requirements for EFIC research.