Informed consent in paediatric critical care research – a South African perspective

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dc.contributor.authorMorrow, Brenda M
dc.contributor.authorArgent, Andrew C
dc.contributor.authorKling, Sharon
dc.date.accessioned2016-11-01T10:18:17Z
dc.date.available2016-11-01T10:18:17Z
dc.date.issued2015-09-09
dc.date.updated2016-10-10T18:04:05Z
dc.description.abstractBackground: 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.en_ZA
dc.identifier.apacitationMorrow, B. M., Argent, A. C., & Kling, S. (2015). Informed consent in paediatric critical care research – a South African perspective. <i>BMC Medical Ethics</i>, http://hdl.handle.net/11427/22387en_ZA
dc.identifier.chicagocitationMorrow, Brenda M, Andrew C Argent, and Sharon Kling "Informed consent in paediatric critical care research – a South African perspective." <i>BMC Medical Ethics</i> (2015) http://hdl.handle.net/11427/22387en_ZA
dc.identifier.citationMorrow, B. M., Argent, A. C., & Kling, S. (2015). Informed consent in paediatric critical care research–a South African perspective. BMC medical ethics, 16(1), 62.en_ZA
dc.identifier.issn1472-6939en_ZA
dc.identifier.ris TY - Journal Article AU - Morrow, Brenda M AU - Argent, Andrew C AU - Kling, Sharon AB - 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. DA - 2015-09-09 DB - OpenUCT DO - 10.1186/s12910-015-0052-6 DP - University of Cape Town J1 - BMC Medical Ethics LK - https://open.uct.ac.za PB - University of Cape Town PY - 2015 SM - 1472-6939 T1 - Informed consent in paediatric critical care research – a South African perspective TI - Informed consent in paediatric critical care research – a South African perspective UR - http://hdl.handle.net/11427/22387 ER - en_ZA
dc.identifier.urihttp://dx.doi.org/10.1186/s12910-015-0052-6
dc.identifier.urihttp://hdl.handle.net/11427/22387
dc.identifier.vancouvercitationMorrow BM, Argent AC, Kling S. Informed consent in paediatric critical care research – a South African perspective. BMC Medical Ethics. 2015; http://hdl.handle.net/11427/22387.en_ZA
dc.languageengen_ZA
dc.language.rfc3066en
dc.publisherBioMed Centralen_ZA
dc.publisher.departmentDepartment of Medicineen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsCreative Commons Attribution 4.0 International (CC BY 4.0)*
dc.rights.holderMorrow et al.
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_ZA
dc.sourceBMC Medical Ethicsen_ZA
dc.source.urihttp://bmcmedethics.biomedcentral.com/
dc.titleInformed consent in paediatric critical care research – a South African perspectiveen_ZA
dc.typeJournal Articleen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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