A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research
AuthorFuryk, J; McBain-Rigg, K; Renison, B; Watt, K; Franklin, R; Emeto, TI; Ray, RA; Babl, FE; Dalziel, S
Source TitleBMC Medical Ethics
University of Melbourne Author/sBabl, Franz
Document TypeJournal Article
CitationsFuryk, J., McBain-Rigg, K., Renison, B., Watt, K., Franklin, R., Emeto, T. I., Ray, R. A., Babl, F. E. & Dalziel, S. (2018). A comprehensive systematic review of stakeholder attitudes to alternatives to prospective informed consent in paediatric acute care research. BMC MEDICAL ETHICS, 19 (1), https://doi.org/10.1186/s12910-018-0327-9.
Access StatusOpen Access
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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