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了联邦法规，这些法规定义了非常具体的情况，在这些情况下，研究可以在不获得参与者预期知情同意的情况下进行。这些法规要求一些特殊的保护措施，包括在进行研究之前进行“社区咨询”（CC），这一规定已被证明是非常有问题的。2003年，NHLBI资助了R01HL073387：“未经同意的研究：社区视角”，以探索社区对这些法规的态度，其潜在的伦理原则和首选的“社区咨询”方法。本申请建议使用原始研究产生的数据、方法和资源继续这项工作，以实现三个具体目标：1)确定和评估为遵守知情同意例外规定而定义和吸引社区的策略；2)开发一个工具包，其中包括面向社区成员的信息材料、最佳做法和成功创新，供正在就紧急研究进行社区咨询的调查人员和内部审查委员会使用；3)制定评估CC的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4种招募方式进行“模拟”社区咨询：概率抽样（随机拨号）；方便抽样（在急诊科候诊室轮询）；目的抽样（社区领导）；配额抽样（按比例反映种族、年龄、社区性别的个体）；使用两种格式：个人查询（随机数字拨号和亲自采访）或小组讨论。为了评估这些CC策略，将开发一个结构化的评估工具，其中包括五个领域的措施：可行性、参与者的组成、沟通质量、社区参与者的看法和IRB/调查员的回应。使用改进的德尔菲过程，专家顾问将评估CC的各种策略和评估措施的有用性。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来比较两种最有前途的CC策略。将评估结构化评估工具的评级者间可靠性。研究人员还将开发一个工具包，其中包括a)从同意研究的所有例外情况的全面审查中汇编最佳做法；B)一系列与文化相适应的信息模块，旨在促进公众参与社区咨询；c)对来自SA-1活动的5个测量域的4种CC策略进行评级；SA-3的结构化评价仪。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协会、政府机构、生物伦理组织和其他组织。

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.