The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent

• Published in: Annals of emergency medicine Vol. 53; no. 3; pp. 341 - 350.e2
• Main Authors: Bulger, Eileen M., MD, Schmidt, Terri A., MD, MS, Cook, Andrea J., PhD, Brasel, Karen J., MD, MPH, Griffiths, Denise E., BS, Kudenchuk, Peter J., MD, Davis, Daniel, MD, Bardarson, Berit, RN, Idris, Ahamed H., MD, Aufderheide, Tom P., MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.03.2009; Elsevier
• Subjects: Adolescent; Adult; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Clinical Trials as Topic - ethics; Clinical Trials as Topic - legislation & jurisprudence; Community Participation - methods; Community-Institutional Relations; Emergency; Emergency and intensive care: techniques, logistics; Emergency Medicine - ethics; Female; Humans; Informed Consent - ethics; Informed Consent - legislation & jurisprudence; Intensive care medicine; Intensive care unit. Emergency transport systems. Emergency, hospital ward; Male; Medical sciences; Qualitative Research; Referral and Consultation - ethics; Referral and Consultation - legislation & jurisprudence; Resuscitation; Telephone; United States; Young Adult; Informed consent; Intensive care; Emergency; Resuscitation
• ISSN: 0196-0644; 1097-6760
• DOI: 10.1016/j.annemergmed.2008.07.021

Study objective In 1996, the Food and Drug Administration and the Department of Health and Human Services enacted rules allowing a narrow exception from informed consent for critically ill patients enrolled in emergency research. These include requirements for community consultation prior to trial implementation. Previous studies have noted difficulty in engaging the community. We seek to describe the experience with random dialing surveys as a tool for community consultation across 5 metropolitan regions in the United States. Methods Random dialing surveys were used as part of the community consultation for an out-of-hospital clinical trial sponsored by the Resuscitation Outcomes Consortium. The survey method was designed to obtain a representative sample of the community according to population demographics and geography. Logistics of survey administration, role of the survey in community consultation, and survey results by population demographics are discussed. Results Random dialing surveys were conducted in 5 of 8 US Resuscitation Outcomes Consortium sites. Overall, 70% to 79% of respondents indicated they would be willing to be enrolled in this study. Support for the inclusion of children (aged 15 to 18 years) ranged from 52% to 71%. Respondents aged 18 to 34 years were more willing to participate in the trial than older age groups. Women and racial minorities were less likely to favor the inclusion of minors. Conclusion Random dialing surveys provide an additional tool to engage the community and obtain a sample of the opinion of the population about research conducted under the emergency exception from informed consent regulations. Similar results were obtained across 5 diverse communities in the United States.