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

急诊医学和危重护理研究的特殊挑战导致了联邦法规 定义非常具体的情况，在这种情况下，可以在没有获得 参与者的预期知情同意。这些规定需要一些特殊的保护。 包括在进行研究之前的“社区咨询”(CC)，这是一项已经证明的条款 这是个极大的问题。2003年，NHLBI资助R01HL073387：“未经同意的研究：社区 以探讨社会各界对这些法规的态度，以及它们的基本伦理原则 和首选的“社区协商”方法。此应用程序建议继续这项工作，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 并评估定义和参与社区的策略，以遵守例外情况 来自知情同意条例；2)开发由社区信息材料组成的工具包 成员、最佳做法和成功的创新，供正在进行研究的调查人员和IRBs使用 就应急研究进行社区咨询；以及3)制定评估充分性的标准 和CC的适当性，并评估这些标准在评估社区中的有用性 咨询过程。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)；方便抽样(在ED等待中轮询 有目的抽样(社区领袖)和配额抽样(按比例 反映邻居的种族、年龄、性别)；使用两种格式：个人查询(随机数字拨号和输入- 个人访谈)或小组讨论。为了评估这些CC战略，一个结构化的评估工具 将制定五个领域的措施：可行性、参与者的组成、质量 沟通，社区参与者的看法和IRB/调查员的回应。使用修改后的Delphi 在这一过程中，专家顾问将评估CC的各种战略和评估的有用性 措施。由此产生的结构化评估工具将在第4年和第5年使用，以比较两个最 使用脚本化研究方案的前景看好的CC战略。结构化评价的评分者间信度 将对仪器进行评估。调查人员还将开发一个工具包，其中包含)最佳做法汇编 来自对所有同意研究例外情况的全面审查；b)一系列文化上合适的 旨在促进公众参与社区咨询的信息模块；以及c)评级 SA-1活动的五个测量领域中的4个CC策略；以及结构化评估 SA-3的仪器。整个工具包将在西奈山EM网站上公开提供，并 将积极地向医学会、政府机构、生物伦理组织和其他机构传播。

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.