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

社区声音（三）：紧急情况下知情同意的社区声音

• 批准号: 9112047
• 负责人: Lynne D. Richardson
• 金额: $ 8.38万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9112047
• 关键词: Address; Attitude; Clinical Trials; Communication; Communities; Complex; Consent; Critical Care; Data; Disclosure; Effectiveness; Electric Countershock; Elements; Emergency Medicine; Emergency Situation; Emergency research; Emergency treatment; Enrollment; Ethics; Feedback; Focus Groups; Funding; Guidelines; Health; Incentives; Informed Consent; Institutional Review Boards; Interview; Life; Methods; Modeling; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; Neurological emergencies; Notification; Observational Study; Outcome; Participant; Patients; Perception; Procedures; Process; Qualifying; Qualitative Methods; Questionnaires; Regulation; Research; Research Personnel; Resources; Resuscitation; Site; Special Exceptions Process; Structure; Study Subject; Testing; Time; Trauma; Work; base; community consultation; cost; design; experience; improved; innovation; meetings; member; prospective; research study; success; treatment trial

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.

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无法获得。当现有治疗效果不令人满意且参与可能会带来直接益处时，联邦法规 21 CFR 50.24 允许知情同意 (EFIC) 的例外情况，以允许招募处于危及生命且无法同意的受试者。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，而且常常不成功，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) 关于执行 CC 和 PD 的最佳实践，缺乏适当社区的定义，以及缺乏衡量不同 CC 方法成功与否的适当指标。为了弥补这些差距，西奈山极其合格的 Community VOICES 研究团队与 NHLBI 资助的复苏结果联盟 (ROC) 和 NINDS 资助的神经急症治疗试验网络 (NETT) 内的多个机构合作开展 EFIC 研究。这项研究将是第一个：1）前瞻性地、系统性地利用多个 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/代理人入组后通知以及研究后公开披露； 2) 使用 VOICES 2 中制定的明确标准（当前应用是竞争性更新），评估 CC 的各种策略在 VOICES 五个领域的有效性：可行性、参与者组成、沟通质量、参与者感知和研究者/IRB 感知； 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。该研究将采用聚合混合方法设计，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。研究结果将为满足 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。