Informed consent in paediatric critical care research--a South African perspective.
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.


CONCLUSIONS
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. 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.
Centre for Medical Ethics and Law, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, PO Box 241, Cape Town, 8000, South Africa. Brenda.morrow@uct.ac.za.
Brenda M
BM
Morrow
Department of Paediatrics and Child Health, University of Cape Town, 5th Floor ICH Building, Red Cross War Memorial Children's Hospital, Klipfontein Rd, Rondebosch, Cape Town, 7700, South Africa. Andrew.argent@uct.ac.za.|Paediatric Intensive Care Unit, Red Cross War Memorial Children's Hospital, Klipfontein Rd, Rondebosch, Cape Town, 7700, South Africa. Andrew.argent@uct.ac.za.
Andrew C
AC
Argent
Centre for Medical Ethics and Law, Department of Medicine, Faculty of Medicine and Health Sciences, Stellenbosch University, PO Box 241, Cape Town, 8000, South Africa. SK@sun.ac.za.|Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Box 241, Cape Town, 8000, South Africa. SK@sun.ac.za.
Sharon
S
Kling
D001007:Anxiety / Q000209:etiology; D026686:Beneficence; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D003422:Critical Care / Q000941:ethics* / Q000331:legislation & jurisprudence; D016638:Critical Illness; D004632:Emergency Medical Services / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007223:Infant; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D007872:Legal Guardians; D010290:Parents / Q000523:psychology*; D010372:Pediatrics / Q000941:ethics* / Q000331:legislation & jurisprudence; D026684:Personal Autonomy; D010817:Physician-Patient Relations / Q000941:ethics; D011446:Prospective Studies; D035844:Researcher-Subject Relations / Q000941:ethics; D018570:Risk Assessment; D013019:South Africa; D013315:Stress, Psychological / Q000209:etiology; D055990:Therapeutic Misconception