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的制定，这些法规定义了非常具体的情况，在这些情况下，可以在没有获得参与者预期知情同意的情况下以符合道德的方式进行研究。这些法规要求采取许多特殊保护措施，包括在研究进行之前进行“社区咨询”（CC），事实证明这一规定存在很大问题。 2003年，NHLBI资助了R01HL073387：“未经同意的研究：社区视角”，以探讨社区对这些法规的态度、其基本道德原则和首选的“社区协商”方法。本申请建议利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) 确定和评估定义和吸引社区的策略，以遵守知情同意例外法规； 2) 开发一个工具包，其中包括供社区成员使用的信息材料、最佳实践和成功创新，供正在进行有关应急研究的社区咨询的调查人员和 IRB 使用； 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协商过程中的有用性。首先，我们将比较4种招募方式来进行“模拟”社区咨询： 概率抽样（随机数字拨号）；便民抽样（在急诊室候诊室进行投票）；有目的的抽样（社区领袖）；配额抽样（按比例反映社区的种族、年龄、性别的个人）；使用两种形式：个人询问（随机数字拨号和面对面访谈）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，其中包含五个领域的衡量标准：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。使用修改后的德尔菲流程，专家顾问将评估 CC 的各种策略以及评估措施的有用性。由此产生的结构化评估工具将在第 4 年和第 5 年使用脚本化研究场景来比较 2 个最有前途的 CC 策略。将评估结构化评估工具的评估者间可靠性。研究人员还将开发一个工具包，其中包括： a) 对同意研究中所有例外情况进行全面审查的最佳实践汇编； b) 一系列适合文化的信息模块，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 网站上公开发布，并将积极向医学会、政府机构、生物伦理学组织等传播。

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.