Research without consent

Community perspectives from the Community VOICES Study

Lynne D. Richardson, Ilene Wilets, Deborah Ragin, Jennifer Holohan, Margaret Smirnoff, Rosamond Rhodes, Gary Winkel, Maggi Rodriguez, Edmund Ricci

Research output: Contribution to journalArticleResearchpeer-review

37 Citations (Scopus)

Abstract

Objective: To explore community attitudes toward the federal regulations that allow investigators to conduct emergency research without obtaining informed consent from participants. Methods: Focus-group participants were recruited from residential sites in New York City that were enrolled in the Public Access Defibrillation (PAD) Trial. The PAD Trial, a National Institutes of Health-funded, randomized trial in which laypersons were trained to treat cardiac arrest, was granted an exception from informed consent under these rules. Community residents and those who had been trained as lay responders in the PAD Trial were asked about the ethical issues raised by the conduct of research without consent (RWC), their definition of community, and appropriate methods of community consultation regarding RWC studies. Grounded theory content analyses were conducted on focus-group data. Results: Seventeen (40%) men and 25 (60%) women from 15 buildings participated in six focus groups: four in English; two in Spanish. Definitions of "community" varied widely among and across groups; no strategy for community consultation was consistently endorsed by the participants. There were significant support and occasional adamant opposition to conducting RWC; participants often recounted specific personal experiences as the basis for both positive and negative opinions. Individuals with negative attitudes toward RWC often voiced strong support for specific RWC scenarios. Conclusions: There is no consensus regarding the definition of "community" or appropriate methods of consultation. Community members' attitudes toward RWC are often shaped by their personal experiences, and their general attitudes often differ from their reactions to specific RWC protocols.

Original languageEnglish
Pages (from-to)1082-1090
Number of pages9
JournalAcademic Emergency Medicine
Volume12
Issue number11
DOIs
StatePublished - 1 Nov 2005

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Third-Party Consent
Research
Focus Groups
Referral and Consultation
Informed Consent
National Institutes of Health (U.S.)
Heart Arrest
Ethics
Consensus
Emergencies
Research Personnel

Keywords

  • Community consultation
  • Emergency research
  • Exception from informed consent
  • Human subjects research
  • Informed consent
  • Waiver of informed consent

Cite this

Richardson, L. D., Wilets, I., Ragin, D., Holohan, J., Smirnoff, M., Rhodes, R., ... Ricci, E. (2005). Research without consent: Community perspectives from the Community VOICES Study. Academic Emergency Medicine, 12(11), 1082-1090. https://doi.org/10.1197/j.aem.2005.06.008
Richardson, Lynne D. ; Wilets, Ilene ; Ragin, Deborah ; Holohan, Jennifer ; Smirnoff, Margaret ; Rhodes, Rosamond ; Winkel, Gary ; Rodriguez, Maggi ; Ricci, Edmund. / Research without consent : Community perspectives from the Community VOICES Study. In: Academic Emergency Medicine. 2005 ; Vol. 12, No. 11. pp. 1082-1090.
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Richardson, LD, Wilets, I, Ragin, D, Holohan, J, Smirnoff, M, Rhodes, R, Winkel, G, Rodriguez, M & Ricci, E 2005, 'Research without consent: Community perspectives from the Community VOICES Study', Academic Emergency Medicine, vol. 12, no. 11, pp. 1082-1090. https://doi.org/10.1197/j.aem.2005.06.008

Research without consent : Community perspectives from the Community VOICES Study. / Richardson, Lynne D.; Wilets, Ilene; Ragin, Deborah; Holohan, Jennifer; Smirnoff, Margaret; Rhodes, Rosamond; Winkel, Gary; Rodriguez, Maggi; Ricci, Edmund.

In: Academic Emergency Medicine, Vol. 12, No. 11, 01.11.2005, p. 1082-1090.

Research output: Contribution to journalArticleResearchpeer-review

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AU - Richardson, Lynne D.

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AU - Ragin, Deborah

AU - Holohan, Jennifer

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AU - Rhodes, Rosamond

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AU - Ricci, Edmund

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AB - Objective: To explore community attitudes toward the federal regulations that allow investigators to conduct emergency research without obtaining informed consent from participants. Methods: Focus-group participants were recruited from residential sites in New York City that were enrolled in the Public Access Defibrillation (PAD) Trial. The PAD Trial, a National Institutes of Health-funded, randomized trial in which laypersons were trained to treat cardiac arrest, was granted an exception from informed consent under these rules. Community residents and those who had been trained as lay responders in the PAD Trial were asked about the ethical issues raised by the conduct of research without consent (RWC), their definition of community, and appropriate methods of community consultation regarding RWC studies. Grounded theory content analyses were conducted on focus-group data. Results: Seventeen (40%) men and 25 (60%) women from 15 buildings participated in six focus groups: four in English; two in Spanish. Definitions of "community" varied widely among and across groups; no strategy for community consultation was consistently endorsed by the participants. There were significant support and occasional adamant opposition to conducting RWC; participants often recounted specific personal experiences as the basis for both positive and negative opinions. Individuals with negative attitudes toward RWC often voiced strong support for specific RWC scenarios. Conclusions: There is no consensus regarding the definition of "community" or appropriate methods of consultation. Community members' attitudes toward RWC are often shaped by their personal experiences, and their general attitudes often differ from their reactions to specific RWC protocols.

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