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，创伤和重症监护研究中通常不可能获得。当可用的治疗不令人满意且参与可能提供直接获益时，联邦法规21 CFR 50.24允许知情同意例外（EFIC），允许入组处于危及生命的情况下无法同意的受试者。满足EFIC研究的额外要求，包括“社区咨询”（CC）和“公开披露”（PD），是困难的，昂贵的，而且往往是不成功的，因为没有足够的数据来指导研究人员和机构审查委员会（IRB）进行CC和PD的最佳实践，缺乏适当社区的定义，以及缺乏适当的度量来衡量不同CC方法的成功。为了解决这些差距，西奈山特别合格的社区声音研究团队与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研究的多个站点合作。本研究将是第一个：1）前瞻性和系统性地使用多个EFIC研究和研究中心，观察CC活动、研究前公开披露、“选择退出”机制、参与者/代理人入组后通知和研究后公开披露; 2）使用VOICES 2中开发的明确标准，（目前的申请是竞争性的更新），以评估CC在五个VOICES领域的各种策略的有效性：可行性、受试者组成、沟通质量、受试者感知和研究者/IRB感知;以及3）收集有关IRB在审查和监督EFIC研究时如何实施第50.24部分的详细定性和定量数据。本研究将采用融合的混合方法设计，在跨学科的概念框架中同时使用定量和定性方法，并合并分析两种类型的数据。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，改善EFIC临床试验对一系列危及生命的疾病的新治疗方法的实施。

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.