Community Consultation for Exception From Informed Consent Studies: Are Market Research Surveys Representative of the Target Community Populations?

Authors

Shannon W Stephens
Russell L Griffin
Christy Carroll-Ledbetter
Sarah Duckert
Margaret Nelson
Joel Rodgers
Adam McClintock
Sara F Goldkind
Luke Gelinas
Amanda E Higley
Stacia DeSantis
Claudia Pedroza
Luis Leon-Novelo
James Stubbs
Marissa B Marques
Henry Wang
John B Holcomb
Jan O Jansen
TROOP Trial Investigators

Language

English

Publication Date

1-1-2025

Journal

Trauma Surgery & Acute Care Open

DOI

10.1136/tsaco-2025-001758

PMID

41409214

PMCID

PMC12706250

PubMedCentral® Posted Date

12-14-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Background: 'Exception from informed consent' research requires community consultation to ensure that the views of the local population have been considered. Using market research companies to distribute surveys across local populations is attractive because it ensures adequate response rates. It is not known whether individuals who respond to surveys are typical of the targeted communities. The purpose of this study is to compare the demographics of the survey respondents with that of the general population in the same area.

Methods: This is an analysis of data collected as part of the 'Trauma Resuscitation with Group O Whole Blood or Products' (TROOP) trial. The surveys used a commercial market research service to reach the communities of interest and consisted of 18 questions designed to evaluate respondents' willingness to be enrolled in the TROOP trial and the demographics of survey respondents.

Results: Catchment populations varied from 0.5 to 9.4 million residents, with a total of 33.5 million. The racial and ethnic composition of the population (and the survey respondents, in brackets) was 44.8% (57.0%) white, 25.7% (13.4%) Hispanic, 12.7% (19.4%) black, 8.0% (2.5%) multiracial, 7.9% (4.4%) Asian, 0.7% (0.9%) Native American, and 0.2% (0.5%) Islanders. Of the male population (and survey respondents, in brackets), 12.2% (15.3%) were aged 18years to 24 years, 20.5% (22.3%) aged 25 years to 34 years, 18.1% (24.9%) aged 35 years to 44 years, 16.3% (18.5%) aged 45 years to 54 years, 15.5% (14.8%) aged 55 years to 64 years, and 17.4% (4.3%) aged 65 years and over. Of the female population (and survey respondents, in brackets), 11.0% (18.5%) were aged 18 years to 24 years, 18.4% (22.6%) aged 25 years to 34 years, 16.4% (23.5%) aged 35 years to 44 years, 15.0% (17.3%) aged 45 years to 54 years, 18.5% (14.1%) aged 55 years to 64 years, and 20.6% (3.9%) aged 65 years and over.

Conclusions: For this trial, using a market research company to distribute community surveys resulted in respondents that are broadly representative of the geographic areas where the trial will be conducted, except for individuals over the age of 65 years and older. This finding provides reassurance to investigators and institutional review boards that the views expressed by respondents are representative of the population where the trial will be conducted.

Level of evidence: III.

Keywords

Ethics, Medical; Multiple Trauma; randomized controlled trial

Published Open-Access

yes

Recommended Citation

Stephens, Shannon W; Griffin, Russell L; Carroll-Ledbetter, Christy; et al., "Community Consultation for Exception From Informed Consent Studies: Are Market Research Surveys Representative of the Target Community Populations?" (2025). Faculty, Staff and Student Publications. 1189.
https://digitalcommons.library.tmc.edu/uthsph_docs/1189