Consent in paediatric research: an evaluation of the guidance provided in the 2007 NHMRC National statement on ethical conduct in human research (original) (raw)
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European Journal of Pediatrics, 2003
To promote and protect the best interests of children involved in biomedical research, paediatricians have to ensure that participating minors and their parents/legal representatives have understood and assented/ consented to the research. Therefore guidelines providing child-specific guidance that are compatible with other international guidelines on informed consent are laid down. Special regard is paid to the willingness to participate and the social and cultural background of the patients, the legal conditions of the countries, the capacity of the child to understand and give his/her informed assent, the adequate communication with the child and the parents, the respect of the will of the patient, the understandable written informed consent of legal representatives and to the evaluation of the informed consent/assent process by competent ethics committees.
Background Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent. Discussion What often remains unclear is the scope of the assent, the procedure for acquiring it, and the way in which children’s capacity to assent is determined. There is a general growing tendency that suggests that the process of assent should be personalised, that is, tailored to a particular child. This article supports the idea of personalisation. However, we also propose placing limits on personalisation by introducing a suggested requirement of assent starting at a school-age threshold. In some situations RECs/IRBs and researchers could reduce the suggested threshold. Summary A recommended age threshold is likely to serve the interests of children better than ambiguous and flexible criteria for personalised age determination.
Clinical research involving children: consideration relating to assent
2013
Physicians and others conducting medical and dental research involving children as participants face quite challenging questions and responsibilities, especially in developing countries. Age, maturity, cognitive development, previous experience, social and cultural contexts, are all factors involved in a minor’s competence to assent. However, the literature has suggested some age thresholds for children to meet assent requirements and skills that they should have to participate meaningfully in decision-making situations regarding their health. This paper discusses the international regulatory documents regarding children consent in Clinical Research
BMC Medical Ethics, 2013
Background: Obtaining a research participant's voluntary and informed consent is the bedrock of sound ethics practice. Greater inclusion of children in research has led to questions about how paediatric consent operates in practice to accord with current and emerging legal and socio-ethical issues, norms, and requirements. Methods: Employing a qualitative thematic content analysis, we examined paediatric consent forms from major academic centres and public organisations across Canada dated from 2008-2011, which were purposively selected to reflect different types of research ethics boards, participants, and studies. The studies included biobanking, longitudinal studies, and gene-environment studies. Our purpose was to explore the following six emerging issues:
Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process
Journal of Childhood Studies, 2021
Utilizing the four features of informed consent from the guiding document Ethical Research Involving Children, the article illustrates how the informed consent process was carried out with young children from the initial planning stages through the ongoing research’s focused conversations. Specifically, the questions of what would be needed to acquire informed consent from the children and what assurances could there be that young children understood the research and how its results would be disseminated are addressed. The article concludes with suggestions for what other researchers might consider and include in their local contexts.
South African Medical Journal, 2018
It is an internationally accepted principle that ethics norms should be applied and enforced in research with humans through ethics review by research ethics committees (RECs). This places RECs at the very heart of the system for protecting participants and enforcing their rights. In the South African ethical-legal framework for child research, there are divergent approaches to consent. That is, section 71 of the National Health Act (No. 61 of 2003) (NHA) requires mandatory parental consent for child research, and limits the authority for proxy consent to parents and legal guardians. However, national ethics guidelines authorised by section 72 of the NHA and issued by the National Health Research Ethics Council (NHREC) acting in terms of its mandate (National Department of Health, 2015) allow a more nuanced approach-i.e. self-consent by older adolescents, provided certain conditions are met, and consent by a range of parental substitutes where there are no available parents or legal guardians. We have argued elsewhere that the consent approach in section 71 is inappropriately restrictive and are of the view that the consent approach endorsed in national ethics guidelines is more defensible. An REC that elects to approve a consent strategy allowable in ethics guidelines is effectively electing to not follow section 71, which raises the question of what the consequences might be for that REC. This article examines the legal liability of RECs through three 'threads' of accountability: the NHREC, the institutions hosting RECs, and the courts. We conclude that: (i) if an REC approves a child protocol with consent strategies allowable in terms of national ethics guidelines but not in terms of section 71, it is unlikely that the NHREC would discipline the REC in the face of a complaint-provided the REC acted within national ethics guidelines issued by the NHREC in terms of the latter's section 72 mandate to set national norms and standards; (ii) if an REC approves a consent approach allowed This open-access article is distributed under Creative Commons licence CC-BY-NC 4.0.
Children's participation and informed consent in research
This paper examines the rights of children as participants in university-based research projects. Human Ethics Committee policies from the eight New Zealand universities are compared to identify and address issues associated with the collection of informed consent, that is, when should researchers obtain parental or guardian consent before children can participate in a research project, and when is a child considered an adult. There are a number of issues that arise when dealing with children in research, particularly in disciplines such as medicine, where, for example, a guardian under certain circumstances can override a child's refusal. Whilst briefly discussing the medical discipline, the primary focus is on research undertaken in social sciences/humanities. To define 'participation' this paper draws on the work of Hart (1992, p.5) where participation is understood to refer to "the process of sharing decisions which affect one's life…". The decision...
Children as Participants of Clinical Research
Journal of Pediatric Infection, 2017
This study presents an overview of the scientific and ethical issues pertaining to the most controversial areas of experimentation on humans (research with children subjects, risk/benefit estimation in paediatric research maturity of children to consent to medical research). Over the past decade, the questions regarding research ethics related to this issue have continuously evolved. The major objective of this paper is that each of these issues will continue to pose new ethical questions and mechanisms in relevant areas for ongoing considerations of these questions. It is essential that we are aware of the ethical issues in various paediatric research studies an continue to search for answers for the numerous ethical challenges, being aware of the vulnerability/defenselessness and capacity development of child participants.