Medical care of critically ill and injured infants and children globally should be based on best research evidence to ensure safe, efficacious treatment. In South Africa and other low and middle-income countries, research is needed to optimise care and ensure rational, equitable allocation of scare paediatric critical care resources.

A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents. The ethical issues are complex, and it is important to consider the perspective of participants, health care workers and researchers on research without prospective informed consent while planning this type of research. We performed a systematic review according to PRISMA guidelines, of empirical evidence relating to the process, experiences and acceptability of alternatives to prospective informed consent, in the paediatric (...) emergency or acute care setting. Major medical databases and grey sources were searched and results were screened and assessed against eligibility criteria by 2 authors, and full text articles of relevant studies obtained. Data were extracted onto data collection forms and imported into data management software for analysis. Thirteen studies were included in the review consisting of nine full text articles and four abstracts. Given the heterogeneity of the methods, results could not be quantitatively combined for meta-analysis, and qualitative results are presented in narrative form, according to themes identified from the data. Major themes include capacity of parents to provide informed consent, feasibility of informed consent, support for alternatives to informed consent, process issues, modified consent process, child death, and community consultation. Our review demonstrated that children, their families, and health care staff recognise the requirement for research without prior consent, and are generally supportive of enrolling children in such research with the provisions of limiting risk, and informing parents as soon as possible. Australian data and perspectives of children are lacking and represent important knowledge gaps. (shrink)

Despite its invasive nature, specific consent for general anaesthesia is rarely sought—rather consent processes for associated procedures include explanation of risk/benefits. In adult intensive care, because no one can consent to treatments provided to incapacitated adults, standardised consent processes have not developed. In paediatric intensive care, despite the ready availability of those who can provide consent, no tradition of seeking it exists, arguably due to the specialty’s evolution from anaesthesia and adult intensive care. With the current Montgomery-related focus on consent, (...) this seems untenable. We undertook a qualitative study in a specialist children’s hospital colocated paediatric/neonatal intensive care (same medical team) in which parental acceptance of admission and entailed procedures is considered implied by virtue of that admission. Semistructured interviews were carried out with both staff and parents to investigate their views about consent, the current system and a proposedblanket consent system, in which parents actively consent at admission to routine procedures. Divergent views emerged: staff were worried that requiring consent at admission might prove a further emotional burden, whereas parents found providing consent a way of coping, feeling empowered and maintaining control. Inconsistencies were found in the way consent is obtained for your routine procedures. Practice does seem inconsistent with contemporary consent standards for medical intervention. Our findings support the introduction of a blanket consent system at admission together with ongoing bedside dialogue to ensure continuing consent. Both parents and staff expressed concern about avoiding possible harmful delays to children due to parental emotional overload and language difficulties. (shrink)