Research Without Consent: The Community Perspective

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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.