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. 2022 Dec:12:100322.
doi: 10.1016/j.resplu.2022.100322. Epub 2022 Oct 20.

Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic

David J Gagnon  1   2   3 , Richard R Riker  3   4   5 , Frank Chessa  6 , Christine Lord  5 , Ashley Eldridge  5 , Meghan Searight  5 , Sarah Bockian  5 , Barbara McCrum  5 , Teresa L May  3   4   5 , Douglas Sawyer  7 , David B Seder  2   3   4   5
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Community consultation for Exception from Informed consent (EFIC) before and during the COVID-19 pandemic

David J Gagnon et al. Resusc Plus. 2022 Dec.

Abstract

Aim: Describe community consultation and surrogate consent rates for two Exception From Informed Consent (EFIC) trials for out-of-hospital cardiac arrest (OOHCA) - before and during the COVID-19 pandemic.

Methods: The PEARL study (2016-2018) randomized OOHCA patients without ST-elevation to early cardiac catheterization or not. Community consultation included flyers, radio announcements, newspaper advertisements, mailings, and in-person surveys at basketball games and ED waiting rooms. The PROTECT trial (2021-present) randomizes OOHCA survivors to prophylactic ceftriaxone or placebo; the community consultation plan during the pandemic included city council presentations, social media posts, outpatient flyers, but no in-person encounters. Demographics for PROTECT community consultation were compared to PEARL and INTCAR registry data, with p-value < 0.05 considered significant.

Results: PEARL surveyed 1,362 adults, including 64 % ≥60 years old, 96 % high school graduates or beyond; research acceptance rate was 92 % for the community and 76 % for personal level. PROTECT initially obtained 221 surveys from electronic media - including fewer males (28 % vs 72 %,p < 0.001) and those > 60 years old (14 % vs 53 %;p < 0.001) compared to INTCAR. These differences prompted a revised community consultation plan, targeting 79 adult in-patients with cardiac disease which better matched PEARL and INTCAR data: the majority were ≥ 60 years old (66 %) and male (54 %). Both PEARL and PROTECT enrolled more patients using surrogate consent vs EFIC (57 %, 61 %), including 71 % as remote electronic consents during PROTECT.

Conclusions: Community consultation for EFIC studies changed with the COVID-19 pandemic, resulting in different demographic patterns. We describe effective adaptations to community consultation and surrogate consent during the pandemic.

Keywords: Cardiac arrest; Community Consultation; Ethics; Exception From Informed Consent (EFIC); Research ethics; Research in emergency settings.

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Figures

Fig. 1
Fig. 1
Comparison of demographic data between Maine Medical Center cardiac arrest patients enrolled in INTCAR during 2018–2019 and community consultation data for the PROTECT trial.
See this image and copyright information in PMC

References

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