Community VOICES (2):Community VOICES on informed consent in emergency situations

描述（由申请人提供）：急诊医学和重症监护研究的特殊挑战导致联邦法规定义了非常具体的情况，在这种情况下，可以在不获得参与者的前瞻性知情同意的情况下进行伦理研究。这些规定要求采取一些特殊保护措施，包括在进行研究之前进行“社区协商”，这一规定已被证明是非常有问题的。2003年，NHLBI资助了R 01 HL 073387：“未经同意的研究：社区观点”，以探讨社区对这些条例的态度、其基本道德原则和“社区协商”的首选方法。本申请建议继续这项工作，使用原始研究产生的数据、方法和资源，以实现三个具体目标：1）确定和评估用于定义和参与社区的策略，以遵守知情同意例外规定; 2）开发一个工具包，包括社区成员的信息材料，最佳实践和成功的创新，供研究者和IRB使用，他们正在进行关于紧急研究的社区咨询; 3）制定评估CC充分性和适当性的标准，并评估这些标准在评估社区咨询过程中的有用性。首先，我们将比较四种招募方法进行“模拟”社区咨询：概率抽样（随机数字拨号）;便利抽样（在艾德候诊室投票）;目的抽样（社区领导人）;和随机抽样（比例反映种族，年龄，社区性别的个人）;使用两种格式：个人查询（随机数字拨号和面对面访谈）或小组讨论。为了评估这些CC战略，将开发一个结构化的评估工具，在五个领域进行测量：可行性，参与者的组成，沟通质量，社区参与者的看法和IRB/调查员的反应。专家顾问将使用经修改的德尔菲程序，评价CC的各种战略和评价措施的有用性。由此产生的结构化评估工具将在第4年和第5年使用脚本研究场景比较2个最有前途的CC战略。将评估结构化评价工具的评分者间可靠性。研究人员还将开发一个工具包，其中包括：a）从对所有同意研究例外情况的全面审查中汇编最佳实践; B）一系列文化上适当的信息模块，旨在促进公众参与社区咨询; c）SA-1活动中五个测量领域的4个CC策略的评级;以及SA-3的结构化评估工具。整个工具包将在西奈山EM网站上公开提供，并将积极传播给医学会，政府机构，生物伦理组织和其他人。

DESCRIPTION (provided by applicant): The special challenges of emergency medicine and critical care research led to federal regulations that define very specific circumstances under which research can be ethically conducted without obtaining prospective informed consent from participants. These regulations require a number of special protections including "community consultation" (CC) before the study is performed, a provision that has proven extremely problematic. In 2003, NHLBI funded R01HL073387: "Research Without Consent: The Community Perspective", to explore community attitudes towards these regulations, their underlying ethical principles and preferred methods of "community consultation". This application proposes to continue this work, using the data, methods and resources produced by the original study, to achieve three specific aims: 1) Identify and evaluate strategies for defining and engaging the community for purposes of adhering to the Exception from Informed Consent regulations; 2) Develop a toolkit consisting of informational materials for community members, best practices and successful innovations for use by investigators and IRBs who are conducting community consultation regarding emergency research; and 3) Develop criteria for evaluating the adequacy and appropriateness of CC and to assess the usefulness of these criteria in evaluating community consultation processes. First, we will compare 4 recruitment methods to conduct "mock" community consultations: Probability Sampling (random digit dialing); Convenience Sampling (polling in ED waiting rooms); Purposive Sampling (community leaders); and Quota Sampling (individuals who proportionately reflect race, age, gender of neighborhood); using two formats: individual queries (random digit dialing & in- person interviews) or group discussion. To assess these CC strategies, a structured evaluation instrument will be developed with measures in five domains: feasibility, composition of participants, quality of communication, community participant perceptions & IRB/investigator responses. Using a modified Delphi process, expert consultants will evaluate the various strategies for CC and the usefulness of evaluation measures. The resulting structured evaluation instrument will be used in years 4 & 5 to compare the 2 most promising CC strategies using scripted research scenarios. Inter-rater reliability of the structured evaluation instrument will be assessed. Investigators will also develop a toolkit with a) compilation of best practices from a comprehensive review of all exception from consent studies; b) a series of culturally-appropriate informational modules designed to facilitate public participation in community consultation; and c) ratings of the 4 CC strategies in the five measurement domains from SA-1 activities; and the structured evaluation instrument for SA-3. The entire toolkit will be made publicly available on the Mount Sinai EM website and will be actively disseminated to medical societies, governmental agencies, bioethics organizations & others.