Informed consent in paediatric critical care research : a South African perspective
Date
2015-09
Journal Title
Journal ISSN
Volume Title
Publisher
BioMed Central
Abstract
Background: 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.
Ethical oversight is essential for safe, appropriate research conduct. Informed consent by the parent or legal guardian is
usually required for child research participation, but obtaining consent may be challenging in paediatric critical care
research. Local regulations may also impede important research if overly restrictive.
By narratively synthesising and contextualising the results of a comprehensive literature review, this paper describes
ethical principles and regulations; potential barriers to obtaining prospective informed consent; and consent options in
the context of paediatric critical care research in South Africa.
Discussion: Voluntary prospective informed consent from a parent or legal guardian is a statutory requirement
for child research participation in South Africa. However, parents of critically ill or injured children might be
incapable of or unwilling to provide the level of consent required to uphold the ethical principle of autonomy. In
emergency care research it may not be practical to obtain consent when urgent action is required. Therapeutic
misconceptions and sociocultural and language issues are also barriers to obtaining valid consent.
Alternative consent options for paediatric critical care research include a waiver or deferred consent for minimal risk
and/or emergency research, whilst prospective informed consent is appropriate for randomised trials of novel therapies
or devices.
Summary: We propose that parents or legal guardians of critically ill or injured children should only be approached to
consent for their child’s participation in clinical research when it is ethically justifiable and in the best interests of
both child participant and parent. Where appropriate, alternatives to prospective informed consent should be considered
to ensure that important paediatric critical care research can be undertaken in South Africa, whilst being cognisant of
research risk. This document could provide a basis for debate on consent options in paediatric critical care research and
contribute to efforts to advocate for South African law reform.
Description
CITATION: Morrow, B. M., Argent, A. C. & Kling, S. 2015. Informed consent in paediatric critical care research : a South African perspective. BMC Medical Ethics, 16:62, doi:10.1186/s12910-015-0052-6.
The original publication is available at http://bmcmedethics.biomedcentral.com
The original publication is available at http://bmcmedethics.biomedcentral.com
Keywords
Paediatrics -- South Africa, Informed consent (Medical law), Medical care
Citation
Morrow, B. M., Argent, A. C. & Kling, S. 2015. Informed consent in paediatric critical care research : a South African perspective. BMC Medical Ethics, 16:62, doi:10.1186/s12910-015-0052-6.