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往往不可能获得。当可用的治疗不令人满意并且参与可能提供直接益处时，联邦法规21 CFR 50.24允许知情同意（EFIC）的例外情况，允许在危及生命的情况下招募无法同意的受试者。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者和机构审查委员会（IRB）进行CC和PD的最佳实践，缺乏适当的社区定义，以及缺乏适当的指标来衡量不同CC方法的成功。为了解决这些差距，西奈山特别合格的社区之声研究小组与nhlbi资助的复苏结果联盟（ROC）和ninds资助的神经急救治疗试验网络（NETT）内的多个站点合作进行EFIC研究。本研究将是第一个前瞻性和系统性的研究，使用多个EFIC研究和站点，观察CC活动，研究前公开披露，“选择退出”机制，参与者/替代受试者的入组后通知，以及研究后公开披露；2)使用在VOICES 2中制定的明确标准（其中当前的应用是竞争性更新）来评估CC的各种策略在五个VOICES领域的有效性：可行性，参与者组成，沟通质量，参与者感知和调查员/IRB感知；3)收集详细的定性和定量数据，说明irb如何在审查和监督EFIC研究中实施第50.24部分。该研究将采用融合的混合方法设计，在跨学科概念框架中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。这些发现将为满足EFIC研究的伦理和监管要求提供实用指导，从而改善针对一系列危及生命的疾病的新疗法的EFIC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.