The random dialing survey as a tool for community consultation for research involving the emergency medicine exception from informed consent. Ann Emerg Med 2009 Mar;53(3):341-50, 350.e1-2
Date
10/01/2008Pubmed ID
18824274Pubmed Central ID
PMC3005614DOI
10.1016/j.annemergmed.2008.07.021Scopus ID
2-s2.0-60249100002 (requires institutional sign-in at Scopus site) 43 CitationsAbstract
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.
Author List
Bulger EM, Schmidt TA, Cook AJ, Brasel KJ, Griffiths DE, Kudenchuk PJ, Davis D, Bardarson B, Idris AH, Aufderheide TP, ROC InvestigatorsAuthor
Tom P. Aufderheide MD Professor in the Emergency Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Clinical Trials as Topic
Community Participation
Community-Institutional Relations
Emergency Medicine
Female
Humans
Informed Consent
Male
Qualitative Research
Referral and Consultation
Resuscitation
Telephone
United States
Young Adult
