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Table 1 Characteristics of included studies

From: A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research

Author/year Setting Phenomenon of interest Study Design Participants Key findings Comments
Bulger EM, 2009[26] U.S. 5 urban centres (Dallas, Milwaukee, Portland, San Diego, Seattle) Description of community consultation process for planned RCT Random dialling survey 500 participants A majority of subjects indicated a willingness to participate in the study should they become eligible.
The average cost of surveys was US$15,000 per site.
Only a small portion data relevant to paeds. Proposed trial was adults, but included questions on children aged 15–17 years
Gamble C, 2012[27] UK, proposed RCT with deferred consent Parental perspectives on proposed use of deferred consent in double blind RCT Postal survey 68 parents and families, 19 (28%) bereaved, members of the Meningitis Research Foundation (MRF). Deferred consent was generally acceptable. Death of a child posed a uniquely difficult situation.
Communication should be flexible and responsive to needs of parents
Harron K, 2015[20] U.K. 12 NHS trusts, RCT (CATCH trial) Consent rates as a percentage of those approached, and those for whom consent was obtained. Descriptive study of consent rates in RCT utilising varying methods of consent 1859 children included in CATCH trial 1859 children included in CATCH, 1358 (73%) admitted on an emergency basis.
Families approached for DC 1178/1358 (87%) of emergency admissions (remaining 180 (13%) not included analysis).
Inclusion rates differed according to whether the child died or survived
Holsti, 2015[32] 15 sites in U.S and Canada. Academic paediatric emergency departments Effectiveness of community consultation and public disclosure activities Mixed methods. Survey of participants. 297 enrolled participants completed de-briefing form. Activities varied widely among sites. Median time from protocol release to final IRB approval was 10 months. Focus groups not associated with another meeting were not well attended. Median cost of $6989.  
Molyneux 2013[21] Kenya and Uganda, RCT Staff and parental perceptions of the consent process Qualitative study of parents and staff 34 interviews with parents of participants, 12 interviews with parents of admitted non-participants, 30 staff interviews. Two focus groups of health workers, 6 interviews with hospital managers. The DC process with prior assent was supported. Prior assent was seen as protecting the interests of both patients and researchers, including through minimising delays in starting treatment.  
Morris, 2004[19] U.S. PICU setting Attitudes to exception to informed consent in a clinical trial Qualitative study Focus groups. Parents of children resuscitated from cardiac arrest n = 12, parents of children in PICU n = 11, PICU nurses n = 13, physicians n = 10, administration n = 10 Concluded prospective informed consent was not feasible and endorsed exception of IC if have an explicit opportunity to decline participation Proposed intervention was to be instituted within 30 min, therefore had more time that other scenarios
Scholefield, 2013[31] 28 UK EDs “appropriateness” of DC Web-based survey 77 Emergency Medicine consultants 74% approved the use of deferred consent in such a trial. Limited data relevant to review question (single question)
Stanley, 2017[24] 16 level I paediatric trauma centre EDs in USA Describe the clinical characteristics, and timing of parent guardian arrival. Prospective, observational study 295 children with blunt head trauma with Glasgow Coma Scale (GCS) scores of 3–12 (i.e., moderate-to-severe TBI). The timing of patient and guardian arrival posed a challenge for timely enrolment. The Federal Exception from Informed Consent for Emergency Research is an important consideration for planning such research. Limited data relevant to review question
Woolfall, 2013[22] UK (clinical trial units) experiences and attitudes of practitioners (doctors and nurses) involved in recruiting to clinical trials in the EC setting. Semi-structured questionnaire 16 consultant grade doctors, 29 research nurses (purposeful sampling) Views on DC differed with experience with the consent method. Practitioners with no experience reported negative perceptions, with concerns about the impact on the parent-practitioner relationship. Practitioners experienced in DC described how families were receptive to the consent method, if conducted sensitively at an appropriate time.  
Woolfall, 2014[28] UK (in setting of planned RCT) To explore the views of parents on proposed RCT i.e. approach to seeking DC and content of PIS. Qualitative study 17 parents (11 telephone interviews) 6 in focus groups. Purposefully sampled from support groups with acute and chronic conditions. Most supported DC to enable progress of emergency care research. The child’s safety was a priority and parents were reassured interventions under investigation are both used in routine clinical practice. Parents made recommendations on the need to individualise approaches bereaved parents. Limitation – low participation rate.
Woolfall, 2015[23] UK multicentre, (setting of RCT CATCH) Parents’ views and experiences of the CATCH trial recruitment, the consent seeking procedures and decision-making Mixed method study (survey, interview and focus groups) 275 parents completed questionnaire, 20 families participated in interviews, 17 clinicians participated in focus groups. Parents felt seeking DC at a time point after their child’s stabilising was more appropriate than seeking consent at an earlier, more critical time point, assisted with considering trial information. Practitioners believed such timing assisted informed decision-making.  
Menzies, 2011 [25](Abstract only) UK PICU Acceptability of consent processes in emergency research Qualitative study Focus groups, 8 adults of 5 children Parents want to make the decision about their child entering a trial. Deferred consent is only acceptable if there is some form of communication with them at trial entry Quality not assessed
Rademacher, 2013[39](Abstract only) USA Parental attitudes about conducting research of therapies for severe TBI in children using EFIC. Cross sectional web based survey 1637 parents of children 0–17. More than a third of parents agree with including children with TBI in research studies when parents are not present for consent, less than half of parents disagree. Quality not assessed
Scholefield, 2011 [29](Abstract only) UK Children’s views on the acceptability of DC Qualitative study Interviews, 14 childen (aged 9 to 18) Trust of the medical profession, and emergency research is safe and therapeutic. Difficulty differentiating between research and clinical decision-making Quality not assessed
Woolfall, 2016 [30](Abstract only) UK Children and young persons views on research without prior consent Qualitative study Interviews, 14 children and young people (aged 7 to 15 years) Supported inclusion in research without prior consent if the trial intervention was thought to be safe and of potential benefit to participants and others. CYP felt that they have the right to be informed and have a say about their participation in a trial as soon as they had recovered Quality not assessed
  1. PIS participant information sheet, USA United States of America, UK United Kingdom, TBI traumatic brain injury, DC deferred consent, IC informed consent, RCT randomised controlled trial, EFIC exception from informed consent, PICU paediatric intensive care unit