Abstract
A child’s objection, refusal and dissent regarding participation in non-beneficial biomedical research must be respected, even when the parents or legal representatives have given their permission. There is, however, no consensus on the definition and criteria of a meaningful and valid child’s objection. The aim of this article is to clarify this issue. In the first part we describe the problems of a child’s assent in research. In the second part we distinguish and analyze two models of a child’s objection to research: the capacity-based model and the distress-based model. In the last part we present arguments for a broader and unified understanding of a child’s objection within regulations and practices. This will strengthen children’s rights and facilitate the entire process of assessment of research protocols.
Highlights
Children’s participation in research that has no potential to produce results of direct benefit to their health should be allowedWidely accepted research ethics guidelines state that research involving children may be carried out only if the following additional conditions are met: 1. research of comparable effectiveness cannot be performed on competent subjects; 2. research is potentially beneficial for the subject population; 3. research entails only minimal risk or, at least, the risks are minimized; 4. an independent ethical body has examined the scientific and ethical merit of the research; 5
In the first part we describe the problems of a child’s assent in research
In the last part we present arguments for a broader and unified understanding of a child’s objection within regulations and practices
Summary
Children’s participation in research that has no potential to produce results of direct benefit to their health (hereafter shortened to ‘‘non-beneficial research’’) should be allowedWidely accepted research ethics guidelines state that research involving children may be carried out only if the following additional conditions are met: 1. research of comparable effectiveness cannot be performed on competent subjects; 2. research is potentially beneficial for the subject population (e.g. in the same age category or afflicted with the same disease or disorder or with the same condition); 3. research entails only minimal risk or, at least, the risks are minimized; 4. an independent ethical body has examined the scientific and ethical merit of the research; 5. Research of comparable effectiveness cannot be performed on competent subjects; 2. Research is potentially beneficial for the subject population (e.g. in the same age category or afflicted with the same disease or disorder or with the same condition); 3. The child’s opinion has been taken into account (WMA 2013; CIOMS 2002; CoE 1997, 2005; EC 2001). This last requirement usually entails an obligation to obtain the minor’s agreement—often known as assent— and an obligation to respect his/her objection or dissent. We distinguish and analyze two models of a child’s objection to research: the capacity-based model and the distress-based model. The terms ‘‘minor’’ and ‘‘child’’ are used in the paper interchangeably, indicating individuals who have not reached the legal age of adulthood and have no legal competence to give informed consent
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