Abstract
BackgroundA 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.MethodsWe 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.ResultsThirteen 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.ConclusionOur 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.
Highlights
A challenge of performing research in the paediatric emergency and acute care setting is obtaining valid prospective informed consent from parents
Aim/objective This paper aims to review and synthesize the available empiric evidence with regard to alternatives to prospective informed consent in the context of paediatric acute care research from the perspective of the children, their families, health care staff, institutions, and the community
Our systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric emergency medicine found the limited available evidence suggested that children, families and practitioners were aware of the limitations of prospective informed consent for emergency and time critical research, were generally supportive and seemed to acknowledge the requirement for alternative strategies
Summary
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. The ethical issues involved in the conduct of paediatric clinical research are complex and are compounded in time critical and life threatening situations in emergency care. The guiding principles of conducting ethical research are: Furyk et al BMC Medical Ethics (2018) 19:89 respect for autonomy, beneficence and justice [4]. Respect for autonomy is usually reflected in obtaining informed consent from participants, which remains a fundamental principle in the protection of human participants in medical research. While proposing to conduct research without informed consent may seem to contravene the ethical principle of respect for autonomy, denying participation in research to those unable to consent contravenes the ethical principle of justice, meaning fair distribution to the benefits of research participation and fair access to the benefits of research [4, 5]
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