Table 5 Characteristics of included studies – waived 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 | ||||||||
39. Blixen 2005a | USA | Stroke | Qualitative (interview) | Evaluate preferences or values | Hypothetical study – emergency stroke research | 12 stroke patients | Yes | No |
40. Dickert 2009 | USA | Cardiac arrest | Qualitative (interview) | Assess views | Hypothetical study scenarios for research emergency research | 22 sudden cardiac death survivors | Yes | No |
41. Kasner 2011 | USA | Acute neurologic emergency research | Qualitative (focus group) | Evaluate views on community consultation | Hypothetical study | Patients with previous stroke or brain injury, their families, and people at risk for traumatic brain injury (n = 40) | Yes | No |
42. Morris 2004 | USA | Paediatrics | Qualitative (focus group and interview) | Public consultation | Proposed in-patient paediatric resuscitation clinical trial | 23 parents from PICU of children who had been resuscitated; 33 staff | Yes | No |
43. Raymond 2010 | USA | Paediatric resuscitation | Mixed methods | Evaluation of public disclosure | Proposed in-patient resuscitation clinical trial | 93 parents attending a PICU | Yes | No |
44. Richardson 2005 | USA | Cardiac arrest | Qualitative (focus group) | Explore attitudes about emergency research without consent | Clinical trial evaluating pre-hospital intervention for cardiac arrest | 42 participants from community where study being conducted | No | No |
45. Shah 2003 | USA | Emergency | Qualitative (content analysis) | Recommendations for public disclosure | Documentation for real studies | 4 studies from repository of mandatory documents | N/A | N/A |
Survey studies | ||||||||
46. Abboud 2006 | USA | Cardiopulmonary arrest | Survey (interview) | Evaluate willingness to participate | Hypothetical scenarios – intervention resuscitation research | 207 Patients attending an emergency department and a 213 geriatric clinic | Mixed | No |
47. Baren 1999 | USA | Paediatric | Survey (interview) | Public consultation (feasibility testing) | Hypothetical clinical trial evaluating treatment for posttraumatic seizures | 227 Parents of children treated in the emergency department | Yes | No |
48. Biros 2009a | USA | Status seizure – | Survey (self-administered) | Part of a public consultation prior to trial initiation. | Proposed trial evaluates pre-hospital intervention for status seizures | 1901 community members | No | Some |
49. Booth 2005 | UK | Cardiac arrest | Survey (self-administered) | Assess attitudes | Hypothetical – emergency research | 361 patients attending an emergency department | No | No |
50. Bulger 2009c | USA | Resuscitation | Survey (interview) | Public consultation | Clinical trials evaluating pre-hospital interventions for cardiac arrest and traumatic injury | 2418 representative sample of community | No | No |
51. Dickert 2013 | USA | Status epileptics | Survey (interview) | Assess experience and effect of public consultation | Clinical trial of a pre-hospital comparing pharmacological interventions for status epileptics | 24 patients; 37 surrogate decision makers | Yes | Yes |
52. Dickert 2014b | USA | Acute traumatic brain injury | Survey (various methods) | Survey nested in public consultation | Clinical trial evaluating progesterone for treatment of traumatic brain injury | 2612 community consultation participants | No | No |
53. Longfield 2008 | USA | Traumatic haemorrhagic shock | Survey (self-administered) | Description of public consultation | Clinical trial evaluating a pre-hospital intervention for traumatic haemorrhagic shock | 150 community meeting attendees | No | No |
54. McClure 2003 | USA | Resuscitation | Survey (interview) | Evaluation of views and public awareness of EFIC research | Studies conducted under waived consent (details unclear) | Convenience sample of 530 patients attending a hospital emergency department | No | No |
55. Morris 2006 | USA | Paediatric resuscitation | Survey (interview) | Assess feasibility of public consultation | Hypothetical scenarios of in-patient resuscitation clinical trials | 91 parents attending a PICU | Yes | No |
56. Nelson 2013 | USA | Cardiac arrest | Survey (interview or self-administered) | Evaluation of patient opt-out experience | Clinical trial evaluating a pre-hospital intervention for cardiac arrest | 46 community members who had opted out of participation in a study conducted under waived consent. | No | No |
57. Ramsey 2011 | USA | Emergency research | Survey (interview) | Evaluation of public consultation methods | Clinical trials conducted under waived consent (detailed unclear)– | Community where study being conducted –(baseline, n = 390; 11 months later, n = 325) | No | No |
58. Scales 2009a | Canada | Critical illness | Survey (interview) | Survey preferences | Hypothetical study scenarios of research during critical illness | 240 survivors of critical illness | Yes | No |
59. Smithline 1998 | USA | Emergency research | Survey (interview) | Evaluate opinions | Hypothetical study scenario of acute care research | Convenience sample of patients in an emergency department 212 | No | No |
60. Triner 2007 | USA | Traumatic haemorrhagic shock | Survey (self-administered) | Evaluation of effectiveness of public disclosure | Clinical trial evaluating a pre-hospital intervention for traumatic haemorrhagic shock | Convenience sample of patients to emergency department 497 | Mixed | No |
Clinical, research staff or regulators | ||||||||
Qualitative studies | ||||||||
61. McClure 2007 | USA | Resuscitation | Qualitative (interviews) | Evaluate experience | Hypothetical – based on experience of protocol review | 10 institutional review board members | Yes | Yes |
Survey studies | ||||||||
62. Cook 2008c | 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 |
63. DeIorio 2007 | USA | Resuscitation | Survey (self-administered) | Understand attitudes | Hypothetical – based on experience of protocol review | 69 research ethics board chairpersons | Yes | Mixed |
64. Dickert 2014a | USA | Status epilepticus | Survey (self-administered) | Assess views and experience of public consultation | Clinical trial of pre-hospital intervention for status epilepticus | 28 research staff | Yes | Yes |
65. Duffett 2011a,b | 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 |
66. Kompanje 2005a | Netherlands | Traumatic brain injury | Survey (self-administered) | Evaluate opinions | Hypothetical -clinical emergency care | 79 neuro-trauma clinical staff across 19 European countries | Yes | Possible |
67. Schmidt 2009 | USA | Severe traumatic injury | Survey (self-administered) | Evaluate opinions and experience of research staff | Real study of pre-hospital intervention for severe trauma | 844 emergency medical technicians participating in the trial | Yes | Yes |