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

描述(由申请人提供)：急诊医学和危重护理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，研究可以在没有获得参与者预期知情同意的情况下进行合乎道德地进行。这些规定需要一些特殊保护，包括在进行研究之前的“社区咨询”(CC)，这一条款已被证明存在极大的问题。2003年，NHLBI资助了R01HL073387：“未经同意的研究：社区视角”，以探索社区对这些规定的态度、其基本伦理原则和“社区协商”的首选方法。本申请建议继续这项工作，利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)确定和评估界定和参与社区的战略，以遵守知情同意条例的例外情况；2)开发一个工具包，其中包括供社区成员使用的信息材料、最佳做法和成功的创新，供正在进行社区紧急研究咨询的调查人员和IRBs使用；以及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，我们会比较四种招募方法，以进行“模拟”社区谘询：概率抽样(随机数字拨号)、方便抽样(在教育署候车室进行投票)、目的抽样(社区领袖)及配额抽样(按比例反映邻里种族、年龄、性别的个人)；采用两种形式：个别询问(随机数字拨号及面谈)或小组讨论。为了评估这些协调委员会战略，将开发一种结构化的评估工具，包括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/调查员的反应。利用改进的德尔菲法，专家顾问将评估CC的各种战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，以使用脚本研究方案比较两个最有希望的CC战略。将对结构化评估工具的评分者间可靠性进行评估。调查人员还将开发一个工具包，其中包括：a)对所有同意研究的例外情况进行全面审查后得出的最佳做法汇编；b)一系列适合文化的信息模块，旨在促进公众参与社区协商；c)SA-1活动在五个衡量领域的4个CC战略的评级；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.