Research Without Consent: The Community Perspective

描述(由申请者提供)：未经同意的研究：社区视角。1996年的联邦法规允许调查人员在满足某些非常具体的标准时获得紧急研究的知情同意豁免，并要求在进行研究之前提供一些特殊保护，包括“社区咨询”和“公开披露”。PAD临床试验是一项由NHLBI资助的多中心随机对照试验，旨在测试以下假设：公共通路除颤(PAD)是一项计划，旨在培训非专业人员使用自动体外除颤器(AED)治疗因院外心脏骤停而晕倒的个人，将显著提高院外心脏骤停患者的存活率。PAD试验方案在放弃紧急研究知情同意的情况下获得批准。纽约市PAD已经招募了59栋住宅楼，这一过程包括与不同级别的决策者进行多次讨论，以及在这些地点召开社区通知会议。大约400名门卫、保安和住院医生接受了仅提供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对以下情况的态度：(A)纽约市PAD试验中“社区”的定义和运作方式、纽约市PAD试验使用的“社区咨询”和“公开披露”程序、为遵守紧急研究同意豁免条例而对“社区”的相关和适当定义；以及(2)确定判断未经同意的研究是否被社区成员接受所涉及的具体因素。我们将领导PAD社区成员的焦点小组，以帮助开展结构化访谈，该访谈将在PAD试验大楼向300名设施决策者、PAD响应者和潜在患者参与者进行。访谈将包含风险、负担、死亡率和潜在益处的不同水平的研究情景，以探索未经同意的研究的可接受限度。分析计划包括组内比较、组间比较和针对按建筑进行的集群的调整。纽约PAD试验为我们提供了一个独特的机会，当正在研究的医疗条件使知情同意变得不可能时，我们可以探索社区成员对研究进行的态度。

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.