Potāto, potăto, proxy consent, permission – just don't call the a whole thing off
Bioethics Department, The Hospital for Sick Children, Toronto, Ontario, Canada.Critical care (London, England) (Impact Factor: 4.48). 05/2005; 9(2):123-4. DOI: 10.1186/cc3037
Research involving critically ill persons highlights challenging questions surrounding third party authorization. The ethical and legal viability in research involving persons who do not have the capacity to consent to participation is not universally accepted, and inconsistent standards are reflected in research ethics guidelines, law and practice. In order to ensure that research participants who are considered incapable of consenting to research are appropriately protected, and that minimal risk research on illnesses affecting those who are unable to consent is enabled, clear and justifiable parameters must be created and, where they are already established, they must be made more transparent.
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ABSTRACT: While clinical trials have advanced the prevention and treatment of child health problems, the recruitment of children into trials still faces numerous challenges. Barriers exist at the levels of society, industry, clinicians, parents and children. Utilizing some of the lessons learned from the successful paradigm of pediatric oncology would promote collaborative networking, a culture of child-focused trial recruitment and adherence to the highest ethical standards in an effort to advance child health. As Dr Harry Shirkey said in 1968, "Every practicing physician, especially pediatricians and pediatric surgeons, departments of pediatrics and departments of pharmacology, should closely examine their own capacities and performance in this area of greatly needed activity... The alternative is to accept the status of 'therapeutic orphans' for their patients."
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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.