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Table 3 Characteristics of included studies – third-party 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

13. Ali 2006

UK

Stroke

Mixed methods

Inform clinical trial design.

Proposed trial evaluates the effect of routine oxygen supplementation after acute stroke

49 stroke patients, 24 carers

Yes

No

14. Blixen 2005a

USA

Stroke

Qualitative (interview)

Evaluate preferences or values

Hypothetical study – emergency stroke research

12 stroke patients

Yes

No

15. Koops 2002

UK

Stroke

Mixed methods

Inform study design.

Proposed study evaluates thrombolysis for acute ischaemic stroke

54 stroke patients and carers

Yes

No

Survey studies

16. Barrett 2012

Canada

ICU

Survey (interview)

Evaluate attitude or opinion

Hypothetical scenarios of ICU research

136 surrogate decision makers of critically ill patients (adults and children)

Yes

No

17. 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

18. Chenaud 2009a

Switzerland

ICU

Survey (Self-administered)

Evaluate preferences

Hypothetical scenarios of ICU research

67 patients; 52 relatives from recent ICU admission

Yes

No

19. Clark 2013

UK

Neurosurgery

Survey (Self-administered)

Part of a public consultation prior to trial initiation.

Proposed study evaluates surgical techniques

171 patients and carers in neuro-surgical clinic

No

No

20. Gigon 2013

Switzerland

ICU

Survey (self-administered)

Evaluate choice

Hypothetical scenarios of ICU research

185 patients, 125 relatives following ICU discharge

Yes

No

21. Kamarainen 2012c

Finland

Cardiac arrest

Survey (Self-administered)

Post-trial evaluation.

Trial evaluated pre-hospital intervention for cardiac arrest

11 patient; 17 consent providers; 13 physicians (trial participants)

Yes

Yes

22. Perner 2010

Denmark

ICU

Survey (self-administered)

Assess attitudes

Hypothetical trials and new medications

42 next-of-kin of unconscious ICU patients

Yes

No

23. Scales 2009a

Canada

Critical illness

Survey (interview)

Survey preferences

Hypothetical study scenarios of research during critical illness

240 survivors of critical illness

Yes

No

24. Schats 2003a

Netherlands

Stroke

Survey (interview)

Post-trial evaluation.

Two trials that evaluated interventions for subarachnoid haemorrhage

49 patients; 47 relatives (trial participants)

Yes

Yes

25. Stephenson 2007

Australia

Emergency care

Survey (self-administered)

Attitudes survey

Hypothetical scenarios of critical care research

185 patients

Possible

No

Clinical, research staff or regulators

Survey studies

26. Burns 2013

Canada

Pandemic research

Survey (self-administered)

Evaluate experiences, beliefs and practices

Hypothetical -pandemic research

168 administrative and clinical staff involved in H1N1 pandemic research

Yes

Yes

27. 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

28. 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

29. 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

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