Research without consent: community perspectives from the Community VOICES Study.
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.
Richardson
Lynne D
LD
Department of Emergency Medicine, Mount Sinai School of Medicine, New York, NY 10029, USA. lynne.richardson@mssm.edu
Wilets
Ilene
I
Ragin
Deborah Fish
DF
Holohan
Jennifer
J
Smirnoff
Margaret
M
Rhodes
Rosamond
R
Winkel
Gary
G
Rodriguez
Maggi
M
Ricci
Edmund
E
D001294:Attitude to Health; D003159:Community-Institutional Relations; D004554:Electric Countershock / Q000706:statistics & numerical data; D004635:Emergency Medicine / Q000941:ethics*; D005260:Female; D017144:Focus Groups; D019538:Health Care Surveys; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D009519:New York City; D018570:Risk Assessment