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

Eileen M. Bulger, Terri Schmidt, Andrea J. Cook, Karen Brasel, Denise E. Griffiths, Peter J. Kudenchuk, Daniel Davis, Berit Bardarson, Ahamed H. Idris, Tom P. Aufderheide

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalAnnals of Emergency Medicine
Volume53
Issue number3
DOIs
StatePublished - Mar 2009

Fingerprint

Emergency Medicine
Informed Consent
Referral and Consultation
Research
Resuscitation
Emergencies
Demography
Surveys and Questionnaires
United States Dept. of Health and Human Services
Population
Minors
Geography
United States Food and Drug Administration
Critical Illness
Age Groups
Clinical Trials

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent. / Bulger, Eileen M.; Schmidt, Terri; Cook, Andrea J.; Brasel, Karen; Griffiths, Denise E.; Kudenchuk, Peter J.; Davis, Daniel; Bardarson, Berit; Idris, Ahamed H.; Aufderheide, Tom P.

In: Annals of Emergency Medicine, Vol. 53, No. 3, 03.2009.

Research output: Contribution to journalArticle

Bulger, Eileen M. ; Schmidt, Terri ; Cook, Andrea J. ; Brasel, Karen ; Griffiths, Denise E. ; Kudenchuk, Peter J. ; Davis, Daniel ; Bardarson, Berit ; Idris, Ahamed H. ; Aufderheide, Tom P. / The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent. In: Annals of Emergency Medicine. 2009 ; Vol. 53, No. 3.
@article{193bf280442d4cfaade95c0ab0f9ee7e,
title = "The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent",
abstract = "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 = "Bulger, {Eileen M.} and Terri Schmidt and Cook, {Andrea J.} and Karen Brasel and Griffiths, {Denise E.} and Kudenchuk, {Peter J.} and Daniel Davis and Berit Bardarson and Idris, {Ahamed H.} and Aufderheide, {Tom P.}",
year = "2009",
month = "3",
doi = "10.1016/j.annemergmed.2008.07.021",
language = "English (US)",
volume = "53",
journal = "Annals of Emergency Medicine",
issn = "0196-0644",
publisher = "Mosby Inc.",
number = "3",

}

TY - JOUR

T1 - The Random Dialing Survey as a Tool for Community Consultation for Research Involving the Emergency Medicine Exception From Informed Consent

AU - Bulger, Eileen M.

AU - Schmidt, Terri

AU - Cook, Andrea J.

AU - Brasel, Karen

AU - Griffiths, Denise E.

AU - Kudenchuk, Peter J.

AU - Davis, Daniel

AU - Bardarson, Berit

AU - Idris, Ahamed H.

AU - Aufderheide, Tom P.

PY - 2009/3

Y1 - 2009/3

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=60249100002&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=60249100002&partnerID=8YFLogxK

U2 - 10.1016/j.annemergmed.2008.07.021

DO - 10.1016/j.annemergmed.2008.07.021

M3 - Article

C2 - 18824274

AN - SCOPUS:60249100002

VL - 53

JO - Annals of Emergency Medicine

JF - Annals of Emergency Medicine

SN - 0196-0644

IS - 3

ER -