This paper provides an introduction to ethical issues arising in children's research that takes place in school-settings. It addresses three main areas of ethical concern: the informed consent process, confidentiality, and harm and benefit. Informed consent in school settings is characterized by the involvement of multiple stakeholders, including not just researchers, parents and individual children but also school principals, teachers and the children's peer group. The added complexity of the setting has implications for the management of the informed consent process, (...) including the decision at what point and in which manner each stakeholder group needs to be involved in the process. The presence and divergent roles of these multiple stakeholders in the school setting also have implications for addressing issues of confidentiality, especially due to the group setting in which participants take part in the research and role expectations within school settings. Harm and benefit in school-based research are of a non-physical nature; relevant areas of concern relate primarily to the potential for psychological and social harm, realistic presentation of likely benefits from research and the issue of rewards for research participation. (shrink)

Assent to medical research or treatment may be an intuitively attractive way to address the area between incapacity and capacity that might otherwise be subject to a best interests assessment. Assent has become a widely disseminated concept in law, research, and clinical ethics, but little conceptual work on assent has so far occurred. An exploration of use of assent in treatment and research in children and people with dementia suggests that at least five claims are made on behalf of assent. (...) Since at least some of these may lead to tensions with others, assent requires firmer conceptual underpinning. Whether assent remains primarily a local approach to research in children in the United States, where it appears to fit with legal background conditions, or develops its promise to overturn the dominant, binary, approach to (in)capacity will depend on the strength of future philosophical work to improve the theoretical foundations to assent. (shrink)

At the outset of an ethnographic inquiry, we navigated national and international resources to search for theoretical and practical guidance on obtaining parents and children’s informed consent/assent. While much theoretical guidance debating ethical issues to children’s participation in research was found, a paucity of published papers offering practical guidance on assent processes and/or visual representations of child assent forms and information sheets was discovered. The purpose of this article is to describe our experiences, both theoretically and practically, of negotiating the (...) process of obtaining informed consent and assent with parents and children for a non-therapeutic qualitative research study. We hope this article instigates a platform for others to explicate their experience and contributes to the construction of a coherent body of knowledge which will clearly delineate important elements that must be considered when negotiating children’s agreement to participate in research. (shrink)

While several studies have explored parents' perceptions of their children's participation in research, very few studies have described the children's own perceptions of their participation in research. The aim of this study was to describe children's perceptions of their participation in a comprehensive longitudinal clinical study. Semi-structured qualitative interviews were conducted with 17 children aged seven participating in the Copenhagen Prospective Study on Asthma in Childhood. The interviews were audiotaped, transcribed and analysed using the template analysis method. The children rated (...) their experiences with venepunctures on a Wong-Baker faces scale. The regular visits to the hospital and comprehensive clinical tests did not seem to have affected the children negatively. In particular, the children would happily engage themselves in medical tests mimicking play (moving, walking, running or playing with a computer). A majority of the children, however, disapproved of the venepunctures and some even refused to have it done. The results of this study indicate that participation in even comprehensive paediatric research can be a positive experience to the participants, with the most popular tests being those that required active participation from the children. (shrink)

We systematically reviewed contemporary literature to create an evidence-informed framework for research studies involving children and adolescents who can assent to participate. We searched seven citation indices to locate peer-reviewed research published in English language journals between 2000 and 2012. After screening 1,231 titles and abstracts for relevance, we assessed levels of evidence, extracted information, and analysed content from 87 articles. Most articles narrowly focused on paediatric assent barriers and facilitators for decision-making about research participation. No articles provided a single, (...) comprehensive ethical framework to guide the development and review of research assent protocols. We developed a 6-step framework that provides guidance to: prepare the child for the assent process; assess the child’s readiness to engage in decision making; discuss the elements of informed consent to the greatest extent possible; seek an initial assent decision; monitor and affirm assent; and respect the child’s role as a research participant. The PAeDS-MoRe framework also supports the creation of process models that address the unique, developmental needs of paediatric sub-groups, and guides the operationalization of jurisdictional requirements for ethical research involving children who are unable to provide free, informed and ongoing consent. (shrink)