Community Consultation for Prehospital Research: Experiences of Study Coordinators and Principal Investigators

• Type of Material: Article
• Authors: Neal Dickert Jr, Emory University; Prasanthi Govindarajan, University of California San Francisco; Deneil Harney, University of Michigan; Robert Silbergleit, University of Michigan; Jeremy Sugarman, Johns Hopkins University; Kevin P. Weinfurt, Duke University; Rebecca Pentz, Emory University
• Language: English
• Date: 2014-04-01
• Publisher: Taylor & Francis: STM, Behavioural Science and Public Health Titles
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2014 National Association of EMS Physicians.
• Final Published Version (URL): http://dx.doi.org/10.3109/10903127.2013.856503
• Title of Journal or Parent Work: Prehospital Emergency Care
• ISSN: 1090-3127
• Volume: 18
• Issue: 2
• Start Page: 274
• End Page: 281
• Grant/Funding Information: Ms. Harney is Human Subjects Coordinator for the NETT CCC.; Dr. Dickert was supported during the study by a postdoctoral fellowship from the National Heart, Lung, and Blood Institute (1F32HL95358-1A1).; Dr. Silbergleit was Principal Investigator of RAMPART and is co-investigator of the NETT Clinical Coordinating Center (CCC), both supported by the National Institute for Neurological Disorders and Stroke (U01NS056975 and U01NS059041).
• Keywords: Emergency Medicine; INFORMED-CONSENT; Life Sciences & Biomedicine; ethics; EMERGENCY EXCEPTION; research ethics; ETHICS; Public, Environmental & Occupational Health; research in emergency settings; community consultation; Science & Technology; bioethics
• Research Categories: Health Sciences, Public Health

Abstract

Objective. To assess principal investigators' and study coordinators' views and experiences regarding community consultation in a multicenter trial of prehospital treatment for status epilepticus conducted under an exception from informed consent for research in emergency settings. Methods. Principal investigators and study coordinators at all 17 hubs for the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART) were invited to complete a web-based survey regarding community consultation at their site for RAMPART. Major domains included 1) perceived goals of community consultation, 2) experiences with and views of community consultation methods used, 3) interactions with IRB regarding community consultation, and 4) general satisfaction and lessons learned. Descriptive statistics were tabulated for Likert scale data; relevant themes were reported for text-based data. Results. Twenty-eight individuals (16 coordinators and 12 investigators) representing all 17 RAMPART hubs completed the survey. Respondents considered multiple community consultation goals to be important, with least support for the role of community consultation in altering study design. All sites used multiple methods (median = 5). The most widely used, and generally favored, method was attending previously scheduled meetings of existing groups. Respondents expressed frustration with low attendance and responsiveness at open public meetings. Conclusions. Coordinators and investigators in this trial viewed community consultation efforts as successful but reported real challenges generating public interest. Individuals with the condition under study were found to be more engaged and supportive of the trial. Respondents endorsed numerous potential goals of the community consultation process and often combined methods to achieve these goals.