Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers
Lee, Kwan S.
Seder, David B.
Riker, Richard R.
Kern, Karl B.
AffiliationUniv Arizona, Div Cardiol, Sarver Heart Ctr
MetadataShow full item record
PublisherELSEVIER IRELAND LTD
CitationEubank, L., Lee, K. S., Seder, D. B., Strout, T., Darrow, M., MacDonald, C., ... & Kern, K. B. (2018). Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers. Resuscitation, 130, 81-87. https://doi.org/10.1016/j.resuscitation.2018.06.031
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AbstractObjectives: Community consultation (CC) is fundamental to the Exception from Informed Consent (EFIC) process for emergency research, designed to inform and receive feedback from the target study population about potential risks and benefits. To better understand the effectiveness of different techniques for CC, we evaluated EFIC processes at two centers participating in a trial of early cardiac catheterization following out-of-hospital cardiac arrest. Methods: We studied the Institutional Review Board-approved CC activities at Maine Medical Center (MMC) and University of Arizona (AZ) in support of NCT02387398. In Maine, the public was consulted by survey at a professional basketball game and in the emergency department waiting room (in-person group), by multimedia direction to an online website (online group), and by mail (mailing group). Arizona respondents were either approached at a county fair (in-person group) or were directed to an online survey (online group) via social media advertising. Results: Among 2185 survey respondents, approval rates were high for community involvement and personal participation without individual consent. Community consultation using in-person, online, and mailed surveys offered slightly different approval rates, and the rate of responses by modality differed by age and education level but not ethnicity. Print advertising was the least cost effective at $ 442 per completed survey. Conclusions: Canvassing at public events was the most efficient mode of performing CC, with approval rates similar to mailings, online surveys, and canvassing in other locations. Print advertisements in local papers had a low yield and cost more than other approaches.
Note12 month embargo; published online: 28 June 2018
VersionFinal accepted manuscript
SponsorsArizona Biomedical Research Commission through an Arizona Biomedical Investigator Award (AZ BIG) entitled, "A Pilot Randomized Clinical Trial of Early Coronary Angiography versus No Early Angiography for Post-Cardiac Arrest Patients without ECG ST Segment [ADHS14-082985]
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