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

社区声音（二）：紧急情况下知情同意的社区声音

• 批准号: 7672089
• 负责人: Lynne D. Richardson
• 金额: $ 3.99万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-15 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7672089
• 关键词: Age; Attitude; Bioethics; Blood; Communication; Communities; Community Consents; Complex; Consent; Consultations; Critical Care; Data; Digit structure; Disclosure; Emergency Medicine; Emergency Situation; Evaluation; Evolution; Funding; Gender; Grant; Heart; Individual; Informed Consent; Institutes; Interview; Left; Lung; Measurement; Measures; Medical Societies; Methods; Morals; Neighborhoods; Notification; Numbers; Participant; Perception; Persons; Probability Samples; Process; Public Participation; Purpose; Race; Rate; Regulation; Research; Research Ethics; Research Ethics Committees; Research Personnel; Resources; Sampling; Series; Structure; Work; design; innovation; instrument; member; prospective; response

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.

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，根据该法规，可以在没有参与者获得前瞻性知情同意的情况下进行道德进行研究。这些法规需要在进行研究之前进行许多特殊保护（包括“社区咨询”（CC）），这一规定被证明是非常有问题的。 2003年，NHLBI资助了R01HL073387：“未经同意的研究：社区观点”，探讨社区对这些法规的态度，其基本的道德原则和“社区咨询”的首选方法。本申请建议使用原始研究产生的数据，方法和资源来继续这项工作，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，以遵守知情同意法规的例外； 2）开发一个工具包，该工具包包括针对社区成员，最佳实践和成功使用的研究人员和IRB的成功创新，他们正在对紧急研究进行社区咨询； 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实用性。首先，我们将比较进行“模拟”社区咨询的4种招聘方法：概率抽样（随机数字拨号）；便利抽样（在ED候诊室进行投票）；目的抽样（社区领导者）；和配额抽样（成比例地反映种族，年龄，邻里性别的个人）；使用两种格式：单个查询（随机数字拨号和人访谈）或小组讨论。为了评估这些CC策略，将通过五个领域的措施开发结构化的评估工具：可行性，参与者的组成，沟通质量，社区参与者的看法和IRB/研究者的回答。使用修改后的Delphi流程，专家顾问将评估CC的各种策略和评估措施的实用性。所得的结构化评估工具将在4和5年内使用，以使用脚本研究方案比较两种最有前途的CC策略。将评估结构化评估工具的评价者间可靠性。调查人员还将开发一个工具包，并通过对同意研究的所有例外进行全面审查，以a）汇编最佳实践； b）一系列具有文化适当的信息模块，旨在促进公众参与社区咨询； c）来自SA-1活动的五个测量域中4 cc策略的评分；以及SA-3的结构化评估工具。整个工具包将在西奈山网站上公开提供，并将积极传播到医疗社会，政府机构，生物伦理学组织等。