Table 4 Characteristics of included studies – deferred consent
Reference | Country | Clinical context | Study design | Study aim | Scenario: real or hypothetical | Study sample | ||
|---|---|---|---|---|---|---|---|---|
Respondents | Direct experience of clinical context or condition | Direct experience of consent model | ||||||
Potential research participants | ||||||||
Qualitative or mixed methods studies | ||||||||
30. Woolfall 2014b | UK | Paediatric – status epilepticus | Qualitative (focus groups, interviews) | Inform study design | Proposed trial evaluating new treatment for status epilepticus | 17 parents | Mixed | No |
Survey studies | ||||||||
31. Chenaud 2009a | Switzerland | ICU | Survey (Self-administered) | Evaluate preferences | Hypothetical scenarios of ICU research | 67 patients; 52 relatives from recent ICU admission | Yes | No |
32. Gamble 2012b | UK | Meningitis | Survey (self-administered) | Investigate views | Proposed trial evaluating two currently used treatments for emergency resuscitation and treatment | 68 families | Yes | No |
33. Gigon 2013a | Switzerland | ICU | Survey (self-administered) | Evaluate choice | Hypothetical scenarios of ICU research | 185 patients, 125 relatives following ICU discharge | Yes | No |
34. Potter 2013 | Australia | ICU | Survey (self-administered) | Post-trial evaluation | Clinical trial evaluating two strategies for maintaining blood sugar in ICU | 210 trial participants | Yes | Yes |
35. Scales 2009a | Canada | Critical illness | Survey (interview) | Survey preferences | Hypothetical study scenarios of research during critical illness | 240 survivors of critical illness | Yes | No |
Clinical, research staff or regulators | ||||||||
Survey studies | ||||||||
36. Cook 2008b | Canada, Australia, New Zealand | Critical illness | Survey (self-administered) | Evaluate experience, beliefs, and practices | Hypothetical – enrolment of critically ill children and adults | 284 clinicians caring for critically ill patients | Yes | Yes |
37. Duffett 2011a | Canada | Critical care research | Survey (self-administered) | Evaluate attitudes and beliefs | Hypothetical scenario of double-blind, placebo-controlled, RCT evaluating single dose of medication perceived by REB as minimal risk | 98 ICU researchers; 52 members of hospital research ethics boards. | Yes | Possible |
38. Woolfall 2013b | UK | Paediatric – status epilepticus | Survey (self-administered) | Evaluate views and experiences | Hypothetical | 45 clinical staff | Yes | Mixed |