Key legislations in many countries emphasize the importance of involving children in decisions regarding their own health at a level commensurate with their age and capacities. Research is engaged in developing tools to assess capacity in children in order to facilitate their responsible involvement. These instruments, however, are usually based on the cognitive criteria for capacity assessment as defined by Appelbaum and Grisso and thus ill adapted to address the life-situation of children. The aim of this paper is to revisit (...) and critically reflect upon the current definitions of decision-making capacity. For this purpose, we propose to see capacity through the lens of essential contestability as it warns us against any reification of what it means to have capacity. Currently, capacity is often perceived of as a mental or cognitive ability which somehow resides within the person, obscuring the fact that capacity is not just an objective property which can be assessed, but always operates within a dominant cultural framework that “creates” that same capacity and defines the threshold between capable and incapable in a specific situation. Defining capacity as an essentially contested concept means using it in a questioning mode and giving space to alternative interpretations that might inform and advance the debate surrounding decision-making. (shrink)

It is widely accepted that children enjoy some form of a right to bodily integrity. However, there is little agreement about the precise nature and scope of this right. This paper offers a conceptual analysis of the child's right to bodily integrity, in order to further elucidate the relationship between the child's right to bodily integrity and considerations of autonomy. Following a discussion of Leif Wenar's work on the structure and justification of rights, I first explain how the adult's right (...) to bodily integrity can be distilled into separate elements that may plausibly be justified by different moral considerations. In particular, I claim that this analysis suggests that whilst the adult's right to bodily integrity is not wholly reducible to bodily autonomy, autonomy nonetheless remains entwined with our understanding of this right in a number of ways. On the basis of this discussion, I go on to outline three important complexities that arise when we consider the child's right to bodily integrity, before particularly focusing on the question of how third parties should determine whether or not to perform a physical interference upon a child who lacks decision-making capacity. Here, I raise some objections to Earp and Mazor's recent attempts to answer this question, before briefly defending an ‘autonomy-based interests’ account of permissible interference, an account that shares in what I take to be the spirit, if not the precise letter, of these earlier views. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in (...) a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

In this article, we develop and defend an account of the normative significance of nonhuman animal agency. In particular, we examine how animals’ agency interests impact upon the moral permissibility of our interactions with them. First, we defend the claim that nonhuman animals sometimes have rights to self-determination. However, unlike typical adult humans, nonhuman animals cannot exercise this right through the giving or withholding of consent. This combination of claims generates a puzzle about the permissibility of our interactions with nonhuman (...) animals. If animals sometimes have rights to self-determination, but lack the capacity to consent, then when, if ever, is it permissible for us to touch them, hold them, bathe them, or confine them? In the second half of the article, we develop a solution to this puzzle. We argue that while we cannot obtain animals’ consent, they can engage in authoritative communications of will through acts of “assent” and “dissent.”. (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)

:To what extent, if any, should minors have a say about whether they participate in research that offers them no prospect of direct benefit? This article addresses this question as it pertains to minors who cannot understand enough about what their participation would involve to make an autonomous choice, but can comprehend enough to have and express opinions about participating. The first aim is to defend David Wendler and Seema Shah’s claim that minors who meet this description should not be (...) offered a choice about whether they participate. The second aim is to show, contra Wendler and Shah, that the principle of nonmaleficence requires more with respect to giving these minors a say than merely respecting their dissent. Additionally, it requires that investigators obtain affirmation of their non-dissent. This addresses intuitive concerns about denying children a choice, while steering clear of the problems that arise with allowing them one. (shrink)

Developmentally, adolescence sits in transition between childhood and adulthood. Involving adolescents in their medical decision-making prompts important and complex ethical questions. Originating in the UK, the concept of Gillick competence is a dominant framework for navigating adolescent medical decision-making from legal, ethical and clinical perspectives and is commonly treated as comprehensive. In this paper, we argue that its utility is far more limited, and hence over-reliance on Gillick risks undermining rather than promoting ethically appropriate adolescent involvement. We demonstrate that Gillick (...) only provides guidance in the limited range of cases where legal decisional authority needs to be clarified. The range of cases where use of Gillick actually promotes adolescent involvement is narrower still, because several features must be present for Gillick to be enacted. Each of these features can, and do, act as barriers to adolescent involvement. Within these limited situations, we argue that Gillick is not specific or strong enough and is reliant on ethically contestable principles. Moreover, in most situations in adolescent healthcare, Gillick is silent on the ethical questions around involving adolescents. This is because it focuses on decisional authority—having the final say in decision-making—which is one small subset of the many ways adolescents could be involved in decision-making. The implication of our analysis is that use of Gillick competence tends to limit or undermine adolescent involvement opportunities. We propose that those working with adolescents should be judicious in seeking Gillick’s guidance, instead drawing on and developing alternative frameworks that provide a comprehensive model for adolescent involvement. (shrink)

In accordance with ethical principles and standards, researchers conducting studies with children are expected to seek assent and respect their dissent from participation. Little attention has been given to assent and dissent in research with toddlers, who have limited cognitive and emotional capabilities. We discuss research with toddlers in the context of assent and dissent and propose guidelines to ensure that research with toddlers still adheres to ethical principles. These guidelines include designing engaging studies, monitoring refusal and distress, and partnering (...) with parents. Research with toddlers requires flexibility and creativity to respect toddlers in the context of their developmental capabilities. (shrink)

BackgroundInformed consent is an important factor in a child’s moral structure from which different types of doctor–patient relationships arise. Children’s autonomy is currently under discussion in terms of their decent treatment, beyond what doctors and researchers perceive. To describe the influential practices that exist among clinicians and researchers toward children with chronic diseases during the process of obtaining informed consent.MethodsThis was a cross-sectional, qualitative study via a subjective and interpretivist approach. The study was performed by conducting semi-structured interviews of 21 (...) clinicians and researchers. Data analysis was performed using the SPSS version 21® and Atlas Ti version 7.0® programs.ResultsThe deliberative and paternalistic models were influential practices in the physician–patient relationship. In the deliberative model, the child is expected to have a moral awareness of their care. The paternalistic model determined that submission was a way of structuring the child because he or she is considered to be a subject of extreme care.ConclusionsThe differentiated objectification [educational] process recognizes the internal and external elements of the child. Informed consent proved to be an appropriate means for strengthening moral and structuring the child. (shrink)

Children do not belong to their parents. They are not property, although throughout much of history they were considered chattel. In the 21st century, it is generally agreed that children are indiv...

Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported (...) a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs. (shrink)

There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that (...) provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research. Based on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process. In providing these rankings, panelists were asked to frame their responses in the contexts of younger and adolescents/older children in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel. Consensus regarding the operational definition was reached by 14/18 of the panel members. Seventeen panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen members agreed with the elements of disclosure for adolescents/older children. It is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children’s developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research. (shrink)

Children’s preferences about medical treatment—like the preferences of other patients—hold moral weight in decision-making that is independent of considerations of autonomy or best interests. In light of this understanding of the moral value of patient preferences, the American Academy of Pediatrics could strengthen the ethical foundation for its formal guidance on pediatric assent.