Gender dysphoria is a clinically significant incongruence between expressed gender and assigned gender, with rapidly growing prevalence among children. The UK High Court recently conducted a judicial review regarding the service provision at a youth-focussed gender identity clinic in Tavistock. The high court adjudged it ‘highly unlikely’ that under-13s, and ‘doubtful’ that 14–15 years old, can be competent to consent to puberty blocker therapy for GD. They based their reasoning on the limited evidence regarding efficacy, the likelihood of progressing to (...) cross-sex hormone therapy and the ‘life-changing consequences’ of puberty blockers. In this article, I offer two concurrent arguments to dispute their reasoning. First, I argue that minors can be competent to consent to puberty blockers for GD, because the decision to undergo puberty blocker therapy is no more complex or far-reaching than other medical decisions that we accept a child should be able to make. Second, I argue that—irrespective of competence—such legal restriction for all children fundamentally contradicts the central ethical tenet of child healthcare: best interests. For these two reasons, the high court should not restrict access to puberty blockers for competent GD children. (shrink)

Background: The ability to consent promotes children’s access to health services. Healthcare providers should assess and arrive at a clinical judgement about the child’s maturity and mental capacity to obtain valid consent. Research objective: The objective of the study was to determine practices employed by South African healthcare providers to obtain consent for treatment from children. Research design: A qualitative, explorative, descriptive research design was used and the study was contextual. Participants and research context: In all, 24 healthcare providers (professional (...) nurses and medical practitioners) were purposively sampled from a hospital and primary health clinics. Semi-structured interviews were used. Ethical consideration: Ethical approval was obtained from the Institutional Review Board and gatekeepers. Written informed consent was obtained from each participant. Findings: Healthcare providers’ current practices in obtaining consent from children revealed inconsistency in implementation as well as the yardstick used to determine children’s mental capacity. Building trust with children, sharing information and assessment were interlinked in obtaining consent. Discussion: The inconsistent practice has implications for children’s access to healthcare services. Conclusion: Inconsistent practices in the implementation of consent laws have the potential to violate children’s rights to bodily and psychological integrity, access to health services and having their opinions heard and be taken into consideration. Through uncovering the current perceptions and practices and a literature review, guidelines intended for use by the Department of Health could be developed. (shrink)

Transgender and gender expansive (TGE) youth often seek a variety of gender-affirming healthcare services, including pubertal suppression and hormone therapy requiring that TGE youth and their parents participate in informed consent and decision making. While youth must demonstrate the ability to understand and appreciate treatment options, risks, benefits, and alternatives as well as make and express a treatment choice, standardized approaches to assess the capacity of TGE youth to consent or assent in clinical practice are not routinely used. This scoping (...) review identified the currently available data regarding adolescent capacity to consent to gender-affirming medical treatments. Articles relevant to assessing adolescent capacity for clinical decision-making were identified using OVID Medline, Web of Science, and PubMed. Articles were reviewed and thematically analyzed. Eight relevant articles were identified using three tools for measuring adolescent clinical decision-making capacity: Measure of Understanding, Measure of Competence, and MacArthur Competence Assessment Tool (MacCAT). These studies explored hypothetical treatment decisions, mental health treatment decisions, HIV treatment decisions, genetic testing decisions, and gender-affirming medical decisions. Only one study specifically examines the capacity of TGE youth to consent to medical treatments. Age was correlated with capacity in most, but not all studies. Other studies found cognitive measures (IQ, literacy, numeracy) may impact important aspects of capacity (understanding and reasoning). For clinicians caring for TGE youth, tools such as the MacArthur Competence Assessment Tool for Treatment (MacCAT-T) may prove useful, in conjunction with consideration of youth developmental abilities and utilization of shared decision-making practices. A standardized, collaborative approach to assessing TGE youth capacity would benefit TGE youth and their parents, and allow clinicians to more easily resolve ethical concerns. (shrink)

Decision-making capacity in children and adolescents in healthcare requires thorough assessment: the minor's maturity, understanding of the decision, risk of the situation and contextual factors needs to be explored. The intention was to design and validate a test—the Maturtest—to assess the maturity of minors in decision-making processes in healthcare. A reasoning test on moral conflicts for adolescents was designed to infer the degree of maturity of minors applied to decision-making regarding their own health. The test was completed by a sample (...) of 441 adolescents aged from twelve to sixteen, with a corresponding analysis of their psychometric skills to measure feasibility, viability, reliability, validity, and sensitivity to change. Psychometric test results showed viability, reliability, validity, and sensitivity to change. High correlation between the test score and the reference method were notable. A high stability was obtained with an intraclass correlation coefficient. The average response time of the test was twenty-three minutes. This test measures the moral maturity of adolescents. It is presented as an objective, useful, valid, reliable tool, easy to fill out, edit and apply in a healthcare context. It helps to assess the maturity of minors faced with a decision. (shrink)

Pediatric biobanking is considered important for generating biomedical knowledge and improving health care. However, the inclusion of children’s samples in biobanks involves specific ethical issues. One of the main concerns is how to appropriately engage children in the consent procedure. We suggest that children should be involved through a personalized assent procedure, which means that both the content and the process of assent are adjusted to the individual child. In this paper we provide guidance on how to put personalized assent (...) into pediatric biobanking practice and consider both the content and process of personalized assent. In the discussion we argue that the assent procedure itself is formative. Investing in the procedure should be a requirement for pediatric biobank research. Although personalized assent will require certain efforts, the pediatric community must be aware of its importance. The investment and trust earned can result in ongoing engagement, important longitudinal information, and stability in/for the research infrastructure, as well as increased knowledge among its participants about research activity. Implementing personalized assent will both respect the child and support biobank research. (shrink)

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. (shrink)

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children’s consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children’s competence to consent to clinical research and to what extent they explain the variation in competence judgments.

For decades, the discussion on children’s competence to consent to medical issues has concentrated around normative concerns, with little progress in clinical practices. Decision-making competence is an important condition in the informed consent model. In pediatrics, clinicians need to strike a proper balance in order to both protect children’s interests when they are not fully able to do so themselves and to respect their autonomy when they are. Children’s competence to consent, however, is currently not assessed in a standardized way. (...) Moreover, the correlation between competence to give informed consent and age in children has never been systematically investigated, nor do we know which factors exactly contribute to children’s competence. (shrink)

Research focused on the prodromal period prior to the onset of psychosis is essential for the further development of strategies for early detection, early intervention, and disease pre-emption. Such efforts necessarily require the enrollment of individuals who are at risk of psychosis but have not yet developed a psychotic illness into research and treatment protocols. This work is becoming increasingly internationalized, which warrants special consideration of cultural differences in conceptualization of mental illness and international differences in health care practices and (...) rights regarding research participation. The process of identifying and requesting informed consent from individuals at elevated risk for psychosis requires thoughtful communication about illness risk and often involves the participation of family members. Empirical studies of risk reasoning and decisional capacity in young people and individuals with psychosis suggest that most individuals who are at-risk for psychosis can adequately provide informed consent; however ongoing improvements to tools and procedures are important to ensure that this work proceeds with maximal consideration of relevant ethical issues. This review provides a discussion of these issues in the context of international research efforts. (shrink)

Assent is an important ethical and legal requirement of paediatric research. Unfortunately, there are significant differences between the guidelines on the details of assent.

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)

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)

Background In Canadian jurisdictions without specific legislation pertaining to research consent, the onus is placed on researchers to determine whether a child is capable of independently consenting to participate in a research study. Little, however, is known about how child health researchers are approaching consent and capacity assessment in practice. The aim of this study was to explore and describe researchers' current practices. Methods The study used a qualitative descriptive design consisting of 14 face-to-face interviews with child health researchers and (...) research assistants in Southern Ontario. Transcribed interviews were analysed for common themes. Results Procedures for assessing capacity varied considerably from the use of age cutoffs to in-depth engagement with each child. Three key issues emerged from the accounts: (1) requirements that consent be provided by a single person thwarted researchers' abilities to support family decision-making; (2) little practical distinction was made between assessing if a child was capable, versus determining if study information had been adequately explained by the researcher; and (3) participants' perceived that review boards' requirements may conflict with what they considered ethical consent practices. Conclusion The results suggest that researchers' consent and capacity knowledge and skills vary considerably. Perceived discrepancies between ethical practice and ethics boards' requirements suggest the need for dialogue, education and possibly ethics board reforms. Furthermore we propose, where appropriate, a ‘family decision-making’ model that allows parents and their children to consent together, thereby shifting the focus from separate assent and consent procedures to approaches that appropriately engage the child and family. (shrink)

Most contributions to the current debate about the consideration and application of empirical information in ethics scholarship deal with epistemological issues such as the role and the meaning of empirical research in ethical reasoning. Despite the increased publication of empirical data in ethics literature we still lack systematic analyses and conceptual frameworks that would help us to understand the rarely discussed methodological and practical problems in appraising empirical research. This paper demonstrates the need for critical appraisal and its crucial methodological (...) role in the application of empirical information in ethical reasoning. Furthermore, it systematically examines the criteria and the appropriate appraisal of empirical research and the associated challenges by highlighting current problems in empirical ethics literature. These problems reveal the following challenges for a critical and responsible consideration of empirical information in ethical reasoning: (i) training in the basic skills of locating and communicating empirical data from the relevant studies; (ii) training in basic knowledge of how to critically appraise empirical (qualitative and quantitative) research and its results; (iii) determination of quality standards for empirical ethics research; (iv) adequate reporting of the methodology and results of empirical ethics research in scientific journals. (shrink)

Patient self-management of disease is increasingly supported by technologies that can monitor a wide range of behavioural and biomedical parameters. Incorporated into everyday devices such as cell phones and clothes, these technologies become integral to the psychosocial aspects of everyday life. Many technologies are likely to be marketed directly to families with ill members, and families may enlist the support of clinicians in shaping use. Current ethical frameworks are mainly conceptualised from the perspective of caregivers, researchers, developers and regulators in (...) order to ensure the ethics of their own practices. This paper focuses on families as autonomous decision-makers outside the regulated context of healthcare. We discuss some morally relevant issues facing families in their decisions to monitor the health-related behaviours of loved ones. An example – remote parental monitoring of adolescent blood glucose – is presented and discussed through the lens of two contrasting accounts of ethics; one reflecting the predominant focus on health outcomes within the health technology assessment (HTA) framework and the other that attends to the broader sociocultural contexts shaping technologies and their implications. Issues discussed include the focus of assessments, informed consent and child assent, and family co-creation of system characteristics and implications. The parents’ decisions to remotely monitor their child has relational implications that are likely to influence conflict levels and thus also health outcomes. Current efforts to better integrate outcome assessments with social and ethical assessments are particularly relevant for informed decision-making about health monitoring technologies in families. (shrink)

Based on extensive questionnaire data, this paper focuses on parents’ views about children’s right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at (...) some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings. (shrink)

There is an increased focus on, and evidence of, children's capability to both understand and make decisions about issues relating to participation in medical research. At the same time there are divergent ideas of when, how and to what extent children should be allowed to decide for themselves. Furthermore, little is known about parents' views on these matters, an important issue since they often provide the formal consent. In this questionnaire study of 2500 families in south-east Sweden (with and without (...) research experience) we explored parents' views on issues relating to information, consent and research data. We found that parents are generally positive about supplying their child with individual information (93.3%; median age 7) and assuring the child's consent/assent to participation (74.3%; median age 12). However, parents' views vary regarding the extent to which children should influence research data: as many as 47–61% of our sample were opposed to children's rights to decide about the use and storage of biological samples and natural history data. Parents who are opposed to child consent and a wider influence on their research participation argue that parental authority and research quality are two important factors opposing enhanced child influence. Drawing on this, we underline the need to discuss how to balance children's rights against parental autonomy and research interests before implementing any standardized protocols granting children the right to consent and revoke data in long-term research. (shrink)

Background South Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality. Discussion This article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, (...) child protection laws, and processes for the ethical and regulatory approval of research. Summary This article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance. (shrink)

The purpose of this article is threefold: (a) to describe the relevant ethical and legal issues associated with decisional capacity among minors and to discuss the importance of these concepts for children and adolescents living with HIV, (b) to provide a framework for assessing the decisional capacity of children and adolescents with HIV, and (c) to present a model for thinking about how to use this assessment data to guide action along the protection-autonomy continuum.

This article addresses ethical issues in conducting randomized clinical trials with youth. Ethical considerations that occur prior to treatment, during treatment, and following treatment are reviewed. Recommendations, based on empirical evidence and clinical experience, are offered for conducting ethical treatment research with youth and future directions for carrying out research on the ethics of conducting RCTs with youth are offered.

Despite a growing need for mental health services for adolescents, treatment access among adolescents remains poor. Psychologists practicing in the United States are subject to highly variable legal standards for consent and confidentiality of minor clients, which can further suppress treatment accessibility. States permit independent consent for minors according to a wide range of criteria, but whether these criteria are empirically derived remains unknown. Inconsistencies between the law and ethical obligations for psychologists can expose minor clients to harm and force (...) psychologists to make disclosures that violate patients’ rights and ethical standards. These harms may be particularly severe for clients from vulnerable populations such as sexuality and gender diverse youth (SGDY). To prevent ethical dilemmas, psychologists and professional organizations should work toward an empirical understanding of the adolescent capacity to consent to mental health care and use that understanding to promote uniform consent and confidentiality standards. (shrink)

Among the "hard cases" of captive animal research is the continued use of chimpanzees in harmful experimental science. In a recent article I contend that contemporary animal welfare science and chimpanzee behavioral studies permit, if not require, a reappraisal of the moral significance of chimpanzee dissent from participation in certain experiments. In what follows, I outline my earlier argument, provide a brief survey of some central concepts in pediatric research ethics, and use these to enrich an understanding of chimpanzee dissent (...) useful for research ethics. (shrink)

Every field of practice has the responsibility to evaluate its outcomes and to test its theories. Evidence of the underdevelopment of measurement instruments in bioethics suggests that attending to strengthening existing instruments and developing new ones will facilitate the interpretation of accumulating bodies of research as well as the making of clinical judgements. A review of 65 instruments reported in the published literature showed 10 with even a minimal level of psychometric data. Two newly developed instruments provide examples of the (...) full use of psychometric and ethical theory. Bioethicists use a wide range of methods for knowledge development and verification; each method should meet stringent standards of quality. (shrink)

In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are introduced through a clinical scenario and discussed as they relate to psychotherapy versus medication RCTs. In each (...) case, suggestions are made for researchers seeking to minimize the impact of these ethical concerns on research participants. (shrink)

With the recent expansion of child mental health research, more attention is being paid to the process of informed consent for research participation. For the consent to be truly informed, it is necessary that the relevant information be both disclosed and actually understood. Traditionally, much effort has gone to ensuring the comprehensiveness of consent/assent documents, which have progressively increased in length and complexity, whereas less attention has been paid to the comprehensibility of these documents. Available data indicate that many parent (...) and children have difficulties appreciating the research nature of treatment studies and that a higher level of formal education among the parents is associated with a greater degree of understanding. Promising approaches to achieving truly informed research participation have emerged, such as additional time for parents to meet with the researchers and using postexplanation questionnaires for identifying issues in need of further clarification. Research is needed to develop and test strategies for improving the effectiveness of the informed consent process in child mental health. (shrink)

Whole genome sequencing is quickly becoming more affordable and accessible, with the prospect of personal genome sequencing for under $1,000 now widely said to be in sight. The ethical issues raised by the use of this technology in the research context have received some significant attention, but little has been written on its use in the clinical context, and most of this analysis has been futuristic forecasting. This is problematic, given the speed with which whole genome sequencing technology is likely (...) to be incorporated into clinical care. This paper explores one particular subset of these issues: the implications of adopting this technology in the prenatal context without a good understanding of when and how it is useful. Prenatal whole genome sequencing differs from current prenatal genetic testing practice in a number of ethically relevant ways. Most notably, whole genome sequencing would radically increase the volume and scope of available prenatal genetic data. The wealth of new data could enhance reproductive decision‐making, promoting parents' freedom to make well‐informed reproductive decisions. We argue, however, that there is potential for prenatal whole genome sequencing to alter clinical practice in undesirable ways, especially in the short term. We are concerned that the technology could (1) change the norms and expectations of pregnancy in ways that complicate parental autonomy and informed decision‐making, (2) exacerbate the deleterious role that genetic determinism plays in child rearing, and (3) undermine children's future autonomy by removing the option of not knowing their genetic information without appropriate justification. (shrink)

This research investigates 266 business students' panel data across 4 time periods and tests a theoretical model involving intrinsic religiosity, the love of money, Machiavellianism, and propensity to engage in unethical behaviors. There was a short ethics intervention between Times 3 and 4. We identified good apples and bad apples using the PUB measure collected at Time 4. From Time 3 to Time 4, good apples became more ethical, whereas bad apples became less ethical after the ethics intervention. Moreover, for (...) the whole sample, intrinsic religiosity deterred unethical intentions not only directly but also indirectly through the absence of Machiavellianism. Before the ethics intervention, intrinsic religiosity curbed unethical intention directly for good apples but indirectly for bad apples. After the intervention, only the indirect effect was significant for bad apples. Intrinsic religiosity offers us hope to open the hearts of the lost sheep and bring them home. Research results were discussed in light of this study's theoretical, empirical, and practical contributions; Judeo-Christian ethics and values; challenging roles of educators and executives in educating Gen-Yers; creating a sea change of the ethical social norm in schools, organizations, and society, or ethical community building, and promoting ethical behavior; and future directions for research. (shrink)

In the last decade, there has been an increased focus on child protection cases in the European Court of Human Rights. The heightened attention on child protection underscores the actuality of children’s rights, rendering it an interesting area for researchers in fields such as children’s rights, child protection, or international relations. All judgments from the Court are public. Research on social media data has shown that public data is not necessarily intended for the public. Moreover, in child protection cases, the (...) child is rarely a part of the case. It is the biological parents against the domestic authorities. Nevertheless, the situation the case revolves around includes the child, making the child an indirect part of the judgment. There is little research on the ethical considerations of indirectly involving children in research on court judgments. However, there is abundant research on ethical considerations in researching public data, specifically social media data. By drawing on research on ethical considerations in the use of social media data, this article delves into the ethical consequences of including children indirectly in research. The article pinpoints crucial areas that require special attention from researchers and provides insights on navigating ethical challenges effectively. (shrink)

From the very beginning of civilization, children are made the subject matter of many social and clinical researches. Due to the vulnerabilities of physical frailty and mental immaturity, children’s interests and rights need to be protected from the risks associated with any kind of research. Recently, there has been increased global concern towards the involvement of children in research for the protection of their rights by the ethical research practice. It emphasizes upon the ongoing nature of ethical considerations that ethical (...) issues need to be considered throughout the research process and even the post research ethical issues are equally significant. The study explores some of the major ethical issues that arise in research involving children during and after the research in terms of the best interests of the children.Bangladesh Journal of Bioethics 2015 Vol.6 (1): 6-10. (shrink)