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Table 2 Studies reporting public opinion of research without consent – Aspects of study design

From: Clinical research without consent in adults in the emergency setting: a review of patient and public views

Author

Country

Study design

Sample

No of subjects

Scenarios/hypothetical studies

Measurements

Smithline & Gerstle (1998) [29]

US

Interview survey

Emergency Dept pts

204

Patient had serious illness

Agree/disagree

     

1. Study intervention with minimal absolute risk

 
     

2. Study intervention with greater than minimal absolute risk

 

McClure et al (2003) [31]

US

Interview survey

Emergency Dept pts & visitors

530

1. Study intervention with minimal absolute risk

5-point Likert scale

     

2. Study intervention with greater than minimal absolute risk

 
     

Two study scenarios:

 
     

1. New therapies for serious bleeding

 
     

2. Efficacy of public access to defibrillation

 

Abboud et al (2006) [32]

US

Interview survey

Emergency Dept pts

207

Patient in cardiac arrest

 
   

Geriatric Clinic pts

213

Two surgical procedures:

 
     

1. Less invasive, intravenous line (minimal risk)

4-point Likert scale

     

2. More invasive, thoracotomy (>minimal risk)

 
     

New experimental medicine in three study designs:

 
     

1. Outside of a study protocol;

 
     

2. Part of a study protocol;

 
     

3. In a randomised controlled trial

 

Goldstein et al (2007). [33]

US

Interview survey

Emergency Dept pts

473

Patient suffered cardiac arrest or stroke

Not stated

Triner et al (2007) [34]

US

Interview survey

Emergency Dept pts & visitors

497

General description of waiver of and exception from informed consent studies

5-point Likert scale

Booth et al (2005) [30]

UK

Self-completion questionnaire

Out-patients

362

Patient suffered heart attack, stroke or head injury

Yes/No/Don't know

     

1. Study intervention with minimal risk

 
     

2. Study intervention with moderate risk

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