Literature DB >> 29964145

Approaches to community consultation in exception from informed consent: Analysis of scope, efficiency, and cost at two centers.

Louis Eubank1, Kwan S Lee2, David B Seder1, Tania Strout1, Matthew Darrow2, Catherine MacDonald2, Teresa May1, Richard R Riker1, Karl B Kern3.   

Abstract

OBJECTIVES: 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.
Copyright © 2018 Elsevier B.V. All rights reserved.

Entities:  

Keywords:  Community; Consent; Consultation; EFIC; Exception; Research

Mesh:

Year:  2018        PMID: 29964145     DOI: 10.1016/j.resuscitation.2018.06.031

Source DB:  PubMed          Journal:  Resuscitation        ISSN: 0300-9572            Impact factor:   5.262


  7 in total

1.  Variations in the application of exception from informed consent in a multicenter clinical trial.

Authors:  Jestin N Carlson; Dana Zive; Denise Griffiths; Karen N Brown; Robert H Schmicker; Heather Herren; George Sopko; Sara DiFiore; Dixie Climer; Caroline Herdeman; Ahamed Idris; Graham Nichol; Henry E Wang
Journal:  Resuscitation       Date:  2018-12-17       Impact factor: 5.262

2.  Public Deliberation as a Novel Method for an Exception From Informed Consent Community Consultation.

Authors:  Patricia E Powers; Karen K Shore; Susan Perez; Dominique Ritley; Nathan Kuppermann; James F Holmes; Leah S Tzimenatos; Hiwote Shawargga; Daniel K Nishijima
Journal:  Acad Emerg Med       Date:  2019-07-24       Impact factor: 3.451

Review 3.  Meeting unique requirements: Community consultation and public disclosure for research in emergency setting using exception from informed consent.

Authors:  Neal W Dickert; Kathleen Metz; Michael D Fetters; Adrianne N Haggins; Deneil K Harney; Candace D Speight; Robert Silbergleit
Journal:  Acad Emerg Med       Date:  2021-05-26       Impact factor: 5.221

4.  Exception from informed consent in the era of social media: The SEGA stroke trial experience.

Authors:  Mehmet Enes Inam; Aditya Sanzgiri; Elvira Lekka; Sunil A Sheth; Andrew D Barreto; Sean I Savitz; Carlos Artime; Claudia Pedroza; Allison Engstrom; Faheem G Sheriff; Alexander Ambrocik; Peng Roc Chen
Journal:  Brain Circ       Date:  2021-12-21

5.  Enrollment with and without exception from informed consent in a pilot trial of tranexamic acid in children with hemorrhagic injuries.

Authors:  Seth W Linakis; Nathan Kuppermann; Rachel M Stanley; Hilary Hewes; Sage Myers; John M VanBuren; T Charles Casper; Matthew Bobinski; Simona Ghetti; Walton O Schalick; Daniel K Nishijima
Journal:  Acad Emerg Med       Date:  2021-08-06       Impact factor: 3.451

6.  Public Approval of Exception From Informed Consent in Emergency Clinical Trials: A Systematic Review of Community Consultation Surveys.

Authors:  William B Feldman; Spencer P Hey; Jessica M Franklin; Aaron S Kesselheim
Journal:  JAMA Netw Open       Date:  2019-07-03

7.  Patient and surrogate attitudes via an interviewer-administered survey on exception from informed consent enrollment in the Prehospital Air Medical Plasma (PAMPer) trial.

Authors:  Insiyah Campwala; Francis X Guyette; Joshua B Brown; Peter W Adams; Barbara J Early; Mark H Yazer; Matthew D Neal; Brian S Zuckerbraun; Jason L Sperry
Journal:  BMC Emerg Med       Date:  2020-10-01
  7 in total

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