Research Without Consent: The Community Perspective

未经同意的研究：社区视角

• 批准号: 6950890
• 负责人: Lynne D. Richardson
• 金额: $ 6.93万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-07-15 至 2006-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6950890
• 关键词: behavioral /social science research tag; cardiopulmonary resuscitation; clinical research; clinical trials; comprehensive medical planning; data collection methodology /evaluation; electric countershock heart resuscitation; emergency care; experimental designs; health behavior; health care policy; health care referral /consultation; health care service availability; health care service planning; health related legal; health science research; health services research tag; heart arrest; hospital community relations; hospital organization /administration; informed consent; interview; public health; training

DESCRIPTION (provided by applicant): Research without Consent: The Community Perspective. 1996 federal regulations allow investigators to obtain a waiver of informed consent for emergency research when certain very specific criteria are met, and require a number of special protections be provided including "community consultation" and "public disclosure" before the study is performed. The PAD Clinical Trial is an NHLBI-funded multi-center randomized, controlled trial to test the hypothesis that Public Access Defibrillation (PAD), a plan to train laypersons to use automated external defibrillators (AEDs) to treat individuals who collapse in cardiac arrest outside of the hospital, will significantly increase survival in out-of-hospital cardiac arrest. The PAD Trial protocol was approved with a waiver of informed consent for emergency research. New York City PAD has recruited 59 residential buildings through a process that involved multiple discussions with decision-makers at various levels, and community notification meetings at the sites. Approximately 400 doormen, security guards, and residents have been trained to provide CPR only (control group), or CPR+AED. The specific aims of our study are: (1) to determine the attitudes of individuals who live or work in the PAD Trial community units towards: (a) the way "community" was defined and operationalized in the NYC PAD Trial, the processes of "community consultation" and "public disclosure" used by the NYC PAD Trial, the relevant and appropriate definition of "community" for purposes of adhering to the Emergency Research Consent Waiver regulations; and (2) to determine the specific factors involved in judging research without consent to be acceptable or unacceptable by community members. We will conduct focus groups of PAD community members to aid in the development of a structured interview that will be administered to 300 Facility Decision Makers, PAD Responders and Potential Patient Participants at the PAD Trial buildings. The interview will contain research scenarios with varying levels of risk, burden, mortality and potential benefit to explore the limits of acceptability of research without consent. The analytic plan includes within group comparisons, between group comparisons and adjustment for clustering by building. The NYC PAD Trial provides us with a unique opportunity to explore the attitudes of community members towards the conduct of research when the medical condition being studied makes informed consent impossible.

描述（由申请人提供）：未经同意的研究：社区观点。 1996年，联邦法规允许调查人员在满足某些非常具体的标准时豁免紧急研究的知情同意书，并需要提供许多特殊保护措施，包括“社区咨询”和“公共披露”。 PAD临床试验是一项NHLBI资助的多中心随机，对照试验，以检验以下假设：公共访问除颤（PAD）是一项培训外行人使用自动化外部除颤器（AED）的计划，以治疗医院外部心脏骤停中崩溃的个人，将大大增加携带携带的生存。 PAD试验方案通过放弃知情同意进行紧急研究的批准。纽约市帕德（New York City Pad）通过一个过程招募了59座住宅建筑，该过程涉及与各个级别的决策者进行多次讨论，并在这些地点进行了社区通知会议。大约有400名门卫，保安人员和居民接受了仅提供CPR（对照组）或CPR+AED的培训。我们研究的具体目的是：（1）确定在PAD试验社区单位生活或工作的个人态度：（a）在NYC PAD试验中定义和运营的“社区”的方式，“社区咨询”的过程，“公共披露”的过程和“公共披露”的纽约PAD试验，NYC PAD试验，相关和适当的“社区”的定义，以实现ADHERS的目的，以实现Adher的目的; （2）确定未经同意的判断研究涉及的特定因素是社区成员可以接受或不可接受的。我们将进行焦点社区成员的焦点小组，以协助开发结构化的访谈，该访谈将在PAD试验建筑物的300个设施决策者，PAD响应者和潜在的患者参与者中进行管理。访谈将包含具有不同风险，负担，死亡率和潜在利益不同的研究场景，以探索未经同意的研究的限制。分析计划包括在组比较中，组比较和通过构建进行聚类调整之间的调整。 NYC PAD试验为我们提供了一个独特的机会，可以探讨社区成员对研究的医疗状况的态度，这使得不可能获得知情同意。