Variables Influencing Willingness to Consent to Low-Risk Study

Including diverse populations in clinical research is essential for generalizable findings. Prior studies show lower consent rates among vulnerable populations in higher-risk studies, but whether these trends apply to minimal-risk studies has not been explored. This study investigated factors influencing consent to a musculoskeletal ultrasound study for extremity injuries in the emergency department. Demographic characteristics, injury severity, interpreter use, and researcher-patient racial concordance were compared between those who consented and declined. Patients were more likely to decline if they were admitted to the hospital (<i>p</i> = 0.002) or had a displaced fracture (displaced-nondisplaced: <i>p</i> = 0.032; displaced-no fracture: <i>p</i> = 0.009). Younger patients (<45 years) most often declined due to pain, while older patients (>45 years) primarily cited lack of interest (<i>p</i> = 0.04). Although not statistically significant, Black and Hispanic patients most often declined for lack of interest. Older adults' lower interest highlights the need to increase research participation in this underrepresented population.

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Publication Details

Journal
Journal of Empirical Research on Human Research Ethics
Published
2026-03-28
DOI
https://doi.org/10.1177/15562646261434107
Primary Topic
Ethics in Clinical Research
Type
article
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article

Variables Influencing Willingness to Consent to Low-Risk Study

Colleen S. Mullins, Christopher Thom
Journal of Empirical Research on Human Research Ethics
Ethics in Clinical Research
article

Variables Influencing Willingness to Consent to Low-Risk Study

Colleen S. Mullins, Christopher Thom
article en

Abstract

Including diverse populations in clinical research is essential for generalizable findings. Prior studies show lower consent rates among vulnerable populations in higher-risk studies, but whether these trends apply to minimal-risk studies has not been explored. This study investigated factors influencing consent to a musculoskeletal ultrasound study for extremity injuries in the emergency department. Demographic characteristics, injury severity, interpreter use, and researcher-patient racial concordance were compared between those who consented and declined. Patients were more likely to decline if they were admitted to the hospital (<i>p</i> = 0.002) or had a displaced fracture (displaced-nondisplaced: <i>p</i> = 0.032; displaced-no fracture: <i>p</i> = 0.009). Younger patients (<45 years) most often declined due to pain, while older patients (>45 years) primarily cited lack of interest (<i>p</i> = 0.04). Although not statistically significant, Black and Hispanic patients most often declined for lack of interest. Older adults' lower interest highlights the need to increase research participation in this underrepresented population.

Journal of Empirical Research on Human Research Ethics
University of Virginia (US)
No poverty
Openalex Percentile: Top 5%
Ethics in Clinical Research
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