Variables Influencing Willingness to Consent to Low-Risk Study

Area of Science:

• Orthopedics
• Clinical Research
• Medical Imaging

Background:

• Diverse populations are crucial for generalizable clinical research findings.
• Vulnerable populations show lower consent rates in higher-risk studies, but this is unexplored in minimal-risk studies.
• Understanding consent factors in minimal-risk studies is vital for equitable research participation.

Purpose of the Study:

• To investigate factors influencing consent to a minimal-risk musculoskeletal ultrasound study for extremity injuries.
• To compare demographic characteristics, injury severity, and other factors between patients who consented and declined.
• To identify barriers to participation in emergency department research.

Main Methods:

• Prospective observational study.
• Inclusion of patients presenting to the emergency department with extremity injuries.
• Comparison of consent and declination groups based on demographics, injury characteristics, interpreter use, and researcher-patient racial concordance.

Main Results:

• Patients admitted to the hospital were more likely to decline consent (p=0.002).
• Patients with displaced fractures were significantly more likely to decline than those with nondisplaced fractures (p=0.032) or no fracture (p=0.009).
• Younger patients (<45) declined due to pain, while older patients (>45) declined due to lack of interest (p=0.04). Black and Hispanic patients also cited lack of interest.

Conclusions:

• Hospital admission and fracture severity are significant factors influencing consent in minimal-risk emergency department research.
• Age-related differences in reasons for declining consent (pain vs. lack of interest) necessitate tailored recruitment strategies.
• The low interest among older adults underscores the need for targeted efforts to enhance research participation in this demographic.