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Table 5 Characteristics of included studies – waived consent

From: Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness

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
  1. acompares different consent models
  2. bcompares different stakeholder groups
  3. cpaediatrics