How can churches empower children-at-risk as ‘vulnerable agents of God’s mission,’ while also protecting them from potential risks for manipulation, exploitation, or spiritual abuse? What is ‘appropriate participation’? What types of manipulation, exploitation, or spiritual abuse might occur in this participation? This essay seeks to define ‘appropriate participation’ in the church and mission, drawing substantially from Hart’s ladder of participation to analyze the participation of children-at-risk as agents of mission. With this as a foundation, spiritual (...) abuse is defined, and a discussion of how this might happen within the realm of child participation in the ministry of the church and mission is presented. Finally, it presents principles and guidelines that the church should consider as they seek to protect children and youth from potential abuse during the process of participating in God’s mission. (shrink)

In this double case study of child psychotherapy, we demonstrate the positive effect of children’s involvement in play activities on their verbal expression of inner emotions and cognitions. Discourse analysis of therapy sessions complemented with the therapist’s reflections show that children who have difficulty in verbalizing hard feelings and cognitions gain control of the communicative situation by getting involved in playful activities. Therapists’ verbal entrance into play can be used to negotiate the therapist–child relationship in terms of power (...) and solidarity. (shrink)

International and UK legislation and policy development in childcare is placing more emphasis on children's participation rights. This continues to present ethical dilemmas for childcare workers who also have the responsibility to ensure the protection and well-being of children. In Wales, the Welsh Assembly Government has made a commitment to the UN Convention on the Rights of the Child in the ?Rights to Action? child welfare policy. In England, the government introduced five aims and outcomes of children's (...) well-being in the ?Every Child Matters? child welfare policy. This paper identifies three barriers to children accessing participation rights, and critically discusses the ethical implications of the English and Welsh child welfare policies for children's participation rights. Family Group Conferences are discussed to highlight dilemmas of participation. (shrink)

Background:Despite growing evidence that participation in psychological trauma research is well tolerated by children and parents, ethics boards may voice concerns regarding research with families...

Involving children in research studies requires obtaining parental permission. A school-based intervention to delay/prevent waterpipe use for 7th and 8th graders in Qatar was developed, and parental permission requested. Fifty three percent (2308/4314) of the parents returned permission forms; of those 19.5% of the total (840/4314) granted permission. This paper describes the challenges to obtaining parental permission. No research to date has described such challenges in the Arab world.

Compared with children, adults are widely assumed to possess more mature moral understanding thus justifying deference to their moral authority and testimony. This paper examines philosophical discussions regarding this child-adult moral relation and its implications for moral education, particularly accounts suggesting that the moral status of children constitute grounds for treating them paternalistically. I contend that descriptions and justifications of this paternalistic attitude towards children are either unacceptably crude or mistaken. While certain instances justify paternalistic treatment towards children, in (...) the context of moral education the paternalistic attitude is largely irrelevant and even counterproductive. I make a case that children can readily meet minimal standards for moral understanding and engagement. Even when children have no final say, there is still a significant normative difference between deferring paternalistically to the adult's moral testimony and interacting with the child in moral conversation. These considered, I defend a social-contextualist account of moral education that incorporates a participatory (over a paternalistic) pedagogical attitude. Further, instead of portraying moral education in terms of stages (as argued by Kohlberg), moral education should be characterized more as a gradual appreciation of and sensitivity to normative demands that apply in various shared contexts and spheres of human concern. (shrink)

The aim of this paper is to show some of the limitations of the Theory of Mind approach to interaction compared to a conversation analytic alternative. In the former, mental state terms are examined as words that signify internal referents. This study examines children’s uses of ‘I want’ in situ. The data are taken from a corpus of family mealtimes. ‘I want’ constructions are shown to be interactionally occasioned. The analysis suggests that (a) a referential view of language does not (...) adequately account for how mental state terms are used in talk, (b) the dominant methodology for examining children’s understanding of ‘desires’ is based on several problematic assumptions. It is concluded that participation in interaction is a social matter, a consideration that is obscured by Theory of Mind and its favoured methods. (shrink)

Twenty-four children (aged 5 months to 18 years) who were admitted to a university hospital were observed for a total of 135 hours with the aim of describing their degree of participation in decisions concerning their own care. Grading of their participation was made by using a 5-point scale. An assessment was also made of what was considered as optimal participation in each situation. The results indicate that children are not always allowed to participate in decision making (...) to the extent that is considered optimal. In no case was it judged that a child participated in or was forced to make a decision that was too difficult for the child. The interactions between children, parents and staff were also described in connection with discussions and decision-making processes. This showed that parents do not always support their children in difficult situations and that health care staff often inform children about what is going to happen without presenting alternatives or asking for their views. Staff may, however, find themselves facing an ethical conflict in deciding between supporting a child’s view or following hospital routine. It is of great importance that children are looked upon as potentially autonomous individuals and that staff members realize that one of their core duties is to facilitate children’s participation in decision making concerning their health care. (shrink)

Parental participation has gained significant attention in environmental psychology, which has revealed a need for an instrument that can measure parental participation with children regarding environmental issues. The present study met this need by validating the parental participation in the environment (PPE) scale. This process began with 45 Chinese parents participating in an individual interview and group discussions, which helped generate a list of eighteen parent-child environmental activities. The activities were then modified and validated in the (...) current study with a diverse group of 969 parents recruited from six major Chinese cities. Both score structure evidence and generalizability evidence were obtained within this sample, and psychometric tests suggested a single factor construct with nine items. Once the PPE scale was revised, it showed measurement invariance across the parent who responded to the items (mother vs. father), across the child’s primary caregiver (mother vs. father vs. grandparent), across the family’s living region (North China vs. South China), as well as across the family’s income group. Finally, evidence based on relations to other variables showed a relationship among parents’ PPE, pro-environmental behavior, and connectedness with nature. As a result, the study provided a novel measure to assess pro-environmental socializationviaparental participation. (shrink)

To identify motivational factors linked to child health status that affected the likelihood of parents’ allowing their child to participate in pediatric research.

How well the Sustainable Development Goals (SDGs) are achieved will greatly influence the lives of today’s children and decisively shape the rest of the 21st century. Yet, children were largely excluded from opportunities to influence the selection of SDGs and their associated targets and indicators, and major barriers to meaningful child engagement remain. However, child-focused agencies have found that when children are intentionally enabled to participate in seeking accountability, they can influence their families, communities and governments to value (...) their contributions and increase their well-being. In furthering its strategy of building brighter futures for children, World Vision implements Citizen Voice and Action (CV&A), a strategic social accountability approach, into communities where children are severely impoverished. Drawing on empirical evidence from children’s CV&A experiences, this paper enquires into the circumstances under which children are empowered to seek accountability for SDGs. This article identifies shared processes which they and others use to strengthen children’s participation in seeking social justice through social accountability. This paper argues that children possess under-recognised research capabilities to think and reflect systemically, critique, understand, and pursue socially just and equitable outcomes conducive to the SDGs, which under the right circumstances, can influence practices, policies, laws and systems. (shrink)

Participation in healthcare decision-making is considered to be an important right of minors, and is highlighted in both international legislation and public policies. However, despite the legal recognition of children’s rights to participation, and also the benefits that children experience by their involvement, there is evidence that legislation is not always translated into healthcare practice. There are a number of factors that may impact on the ability of the child to be involved in decisions regarding their medical (...) care. Some of these factors relate to the child, including their capacity to be actively involved in these decisions. Others relate to the family situation, sociocultural context, or the underlying beliefs and practices of the healthcare provider involved. In spite of these challenges to including children in decisions regarding their clinical care, we argue that it is an important factor in their treatment. The extent to which children should participate in this process should be determined on a case-by-case basis, taking all of the potential barriers into account. (shrink)

The increasing emphasis on participation in education offers the starting point for this paper. Participation appears to be a strategic notion in a particular problematisation of education: this is installed through certain ways of speaking and writing (discourse) and through certain procedures, instruments and techniques that are proposed and developed in different places and spaces (technology). Participation is thereby claimed to empower individuals and to emancipate the child or the student from dominant regimes of power, including (...) liberating them from oppressive traditional educational practices. Foucault's concept of governmentality, which offers us a specific understanding of power, helps us to analyse the discourse and technology of participation in a different way: participation comes to be seen not as an increase in freedom and empowerment, but as an element in a particular mode of government or power. According to this analysis the plea for practices of participation appears as an interpellation or call, governing the way that people act and behave, and encouraging them to think of themselves in a very specific way. We characterise this in terms of immunisation. (shrink)

Background Genuine uncertainty on superiority of one intervention over the other is called equipoise. Physician-investigators in randomized controlled trials need equipoise at least in studies with more than minimal risks. Ideally, this equipoise is also present in patient-participants. In pediatrics, data on equipoise are lacking. We hypothesize that 1) lack of equipoise at enrolment among parents may reduce recruitment; 2) lack of equipoise during participation may reduce retention in patients assigned to a less favoured treatment-strategy. Methods We compared preferences (...) of parents/patients at enrolment, documented by a questionnaire, with preferences developed during follow-up by an interview-study to investigate equipoise of child-participants and parents in the BeSt-for-Kids-study. This trial in new-onset Juvenile Idiopathic Arthritis-patients consists of three strategies. One strategy comprises initial treatment with a biological disease-modifying-antirheumatic-drug, currently not standard-of-care. Semi-structured interviews were conducted with 23 parents and 7 patients, median 11 months after enrolment. Results Initially most parents and children were not in equipoise. Parents/patients who refused participation, regularly declined due to specific preferences. Many participating families preferred the biological-first-strategy. They participated to have a chance for this initial treatment, and would even consider stopping trial-participation when not randomized for it. Their conviction of superiority of the biological-first strategy was based on knowledge from internet and close relations. According to four parents, the physician-investigator preferred the biological-first-strategy, but the majority stated that she had no preferred strategy. In phase 2, preferences tended to change to the treatment actually received. Conclusions Lack of equipoise during enrolment did not reduce study recruitment, mainly due to the fact that preferred treatment was only available within the study. Still, when developing a trial it is important to evaluate whether the physicians’ research question is in line with preferences of the patient-group. By exploring so-called ‘informed patient-group’-equipoise, successful recruitment may be enhanced and bias avoided. In our study, lack of equipoise during trial-participation did not reduce retention in those assigned to a less favoured option. We observed a change for preference towards treatment actually received, possibly explained by comparable outcomes in all three arms. (shrink)

When a child is hospitalized, the parents find themselves in an unfamiliar environment and their parental role changes. They are in a stressful and often anxiety-filled situation and it may be difficult for them to participate in decisions. The purpose of this study was to examine the extent to which parents participate in decisions during the course of events when their child is hospitalized. Thirty-five parents of 24 children (aged 5 months to 18 years) were followed by mobile (...) observation during their child’s hospitalization in a paediatric department in Sweden. Three researchers analysed field notes in three steps, using manifest and latent coding. In step 1, 119 situations that included a decision process were identified. In step 2, the situations were assessed according to a five-level scale concerning how the parents’ wishes, desires or values had been respected. In step 3, each situation was scrutinized with respect to factors influencing the extent of the parents’ participation. The results showed that parents have varying ability to be involved in decision making. Professionals need to communicate more openly with them in order to identify and satisfy their needs because some parents are unwilling or incapable of expressing them. (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)

Background: Pediatric guidelines recommend that children and adolescents participate in a developmentally appropriate way in end-of-life decision making. Shared decision making in pediatrics is unique because of the triadic relationship of patient, parents, and physician. The involvement of the patient may vary on a continuum from no involvement to being the sole decision maker. However, the effects of child participation have not been thoroughly studied. The aims of this literature review are to identify studies on end-of-life decision making (...) in pediatrics, to explore patient participation, and to assess the effects of such participation. Methods: Five databases—PubMed, PsycInfo, Medline, CINAHL, and Sociological Abstract—were searched for empirical studies on end-of-life decision making in pediatrics. Selected articles fulfilling the criteria were assessed for type of decision, participants’ characteristics, reports on participation of the minor patient, and outcome. Results: Fifty-seven articles on end-of-life decision making in pediatrics were identified. The majority of papers (n = 43, 75%) investigated parents’ and clinicians’ perspectives, while only 14 articles (25%) included perspectives of children and adolescents. Twenty-two articles (39%) reported some details on various forms of children's participation (e.g., receive information, plan care details, consulted before or after a decision was made). Positive (e.g., respect for patient's preferences) and negative (e.g., conflict due to diverging opinions) effects of children's participation in end-of-life decision making were reported. Conclusions: This systematic review highlights the need for research to identify factors that contribute to a favorable participation of minors in decision-making processes, as well as strategies to solve possible conflicts. More research should take into account the dynamics in the triadic process of decision making and emphasize children and adolescents’ perspectives. A better understanding of how to meaningfully involve children and adolescents in end-of-life decision making could facilitate the practice of patient participation in pediatrics. (shrink)

This article discusses the practical implications and ethical dilemmas of ‘other’ adults being present in a research setting where the participant is a child. The article focuses on three key issues in relation to this theme. First, the range of ways that ‘other’ adults (for example, parents or guardians, teachers or youth workers) may become involved in the process of research is discussed. Second, the article considers how the presence of ‘other’ adults may raise ethical challenges, impact on the (...) research process, and ultimately affect the data collected. Finally, suggestions are offered for the range of strategies open to researchers in negotiating the involvement of ‘other’ adults within a research context. (shrink)

This article provides an analysis of participation within the framework of language socialization with a focus on the child’s position as overhearer. The study suggests that a particular position as creative imitator is to be included within models of participation in order to account for the particular transition position in which the child transforms his position from overhearer to speaker. Through an empirical study it is demonstrated how an overhearing child embeds his contributions within the (...) local social and interactional order through repetitions of other participants’ contributions. It is argued that these repetitions are social acts by which the child displays involvement in family conversations by orienting to their perspectives. The child can be seen to learn through others and not only from others. (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)

Researchers studying at-risk and socially disenfranchised child and adolescent populations are facing ethical dilemmas not previously encountered in the laboratory or the clinic. One such set of ethical challenges involves whether to: (a) share with guardians research derived information regarding participant risk, (b) provide participants with service referrals, or (c) report to local authorities problems uncovered during the course of investigation. The articles assembled for this special section address the complex issues of deciding if, when, and how to report (...) or provide referrals for research participants who are minors (referred to hereafter as minor research participants). This paper focuses on two factors underlying these decisions: the validity of risk estimates and meta-ethical positions on scientific responsibility. It is suggested that, before sharing information about minor research participants investigators should do the following: critically examine the diagnostic validity of developmental measures, include the scope and limitations of information sharing in informed consent procedures, and become familiar with state reporting laws. I discuss the impact of the traditionally accepted act utilitarian meta-ethical position on the investigator-participant relationship, and I recommend consideration of alternative positions as a step toward developing a research ethic of scientific responsibility and care. (shrink)

This paper aims to reflect upon ethical dilemmas arising from educational research in humanitarian contexts, particularly when involving children. In recognition of the paucity of knowledge on how...

BackgroundCritical to conducting high quality research is the ability to attract and retain participants, especially for longitudinal studies. Understanding participant experiences and motivators or barriers to participating in clinical research is crucial. There are limited data on healthy participant experiences in longitudinal research, particularly in low- and middle-income countries. This study aims to investigate quantitatively participant experiences in a South African birth cohort study.MethodsMaternal participant experience was evaluated by a self-administered survey in the Drakenstein Child Health Study, a longitudinal (...) birth cohort study investigating the early life determinants of child health. Pregnant mothers, enrolled during the second trimester, were followed through childbirth and the early childhood years. Satisfaction scores were derived from the participant experience survey and quantitatively analyzed; associations between satisfaction scores and sociodemographic variables were then investigated using a linear regression model.ResultsData were included from 585 pregnant mothers, who had participated in the study for a median time of 16 months. Overall participant satisfaction was high and associated with increased attendance of study visits. Reasons for participating were a belief that involvement would improve their health, their child’s health or the health of family and friends. Potential reasons for leaving the study were inconvenience, not receiving clinical or study results, and unexpected changes in study visits or procedures. Variables associated with higher overall satisfaction scores were no prior participation in research, higher socioeconomic status, less intensive follow-up schedules and having experienced stressful life events in the past year.ConclusionsSatisfaction scores were high and associated with increased visit attendance. Participants’ perceived benefits of study participation, most notably the potential for an improvement in the health of their child, were a significant motivator to enroll and remain in the study. The consistent theme of perceived health benefits as a motivator to join and remain in the study raises the question of whether participation in research results in actual improvements in health. (shrink)

Ethical issues regarding research biobanks continue to be a topic of intense debate, especially issues of confidentiality, informed consent, and child participation. Although considerable empirical literature concerning research biobank ethics exists, very little information is available regarding the opinions of medical professionals doing genetics research from the Middle East, especially Arabic speaking countries. Ethical guidelines for research biobanks are critically needed as some countries in the Middle East are starting to establish national research biobanks. Islam is the dominant (...) religion in these countries, and it affects people’s behavior and influences their positions. Moreover, communities in these countries enjoy a set of customs, traditions and social norms, and have social and familial structures that must be taken into account when developing research policies. We interviewed 12 medical professionals from the Middle East currently working with stored tissue samples to document their opinions. We found general agreement. Participants’ primary concerns were similar to the views of researchers internationally. Since children tend to represent a high percentage of Middle Eastern populations, and because children’s bodies are not just small adult bodies, the interviewed professionals strongly believed that it is imperative to include children in biobank research. Participants generally believed that protecting confidentiality is socially very important and that informed consent/assent must be obtained from both adult and child participants. This study provides a starting point for additional studies. (shrink)

More than 24,000 patients await organ transplants and the number is increasing yearly. Living donors are an important source of transplant organs. In this paper, I argue that we can morally justify allowing children to serve as donors. Yet, I also argue that their participation must be restricted in order to prevent their exploitation.The paper is divided into six sections. In the first section, I show why the traditional principles of personal autonomy and beneficence are not adequate morally to (...) justify the participation of children in the nontherapeutic role of organ donor. Next, I argue that the moral justification of the child’s participation must be based on the intimate family relationship which permits activities that would be unacceptable in the public domain. In the third section, I argue that family autonomy ought to be limited by the principle of respect for persons. In the fourth section, I propose five principles to guide the participation of children as organ donors. In section five, I discuss the role of the child in the decision-making process. In section six, I critically examine the criteria for equity in donor selection. (shrink)

Background The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues (...) like sexual behaviour or substance use. Discussion South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. Conclusion Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies. (shrink)

Background Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials. Objective To explore such perceptions and attitudes in Lebanese parents. Study design 33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed (...) in colloquial Arabic, and later subjected to thematic analysis. Results Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term ‘randomisation’ hindered parental approval of participation. Conclusion Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation. (shrink)

Background Seeking assent from children for participation in medical research is an ethical imperative of numerous institutions globally. However, none of these organizations provide specific guidance on the criteria or process to be used when obtaining assent. The primary objective of this scoping review was to determine the descriptions of assent discussed in the literature and the reported criteria used for seeking assent for research participation in pre-adolescent children. Methods Medline and Embase databases were searched until November 2020 (...) using the term “assent” in the title or abstract. Inclusion criteria were (1) studies enrolling children which specifically described operationalization of the assent process and (2) studies of the assent process which provided a description of assent. Data collected included participant information, patient criteria for seeking assent, guidelines referenced, description of assent reported, how assent was obtained and assent information presented, and reported assent rate. For qualitative articles focusing on the assent process, important themes were identified. Results A total of 116 articles were included of which 79 (68.9%) operationalized assent and 57 studies (%) described the assent process. The most commonly reported criterion used to determine the ability of a child to assent was age (35.4%, 28/79). The reported minimal age for obtaining pediatric assent varied considerably across and within jurisdictions (5–13 years; median 7.5 years, IQR 7.0, 9.75). Cognitive ability was reported as a criterion for obtaining assent in 5.1% (4/79) of studies. Assent rates were only reported in 17.7% (14/79) of citations and ranged from 32.0 to 100%. Analysis of the 57 studies describing the assent process identified several themes, including age thresholds, assessment of capacity, variable knowledge of pediatric assent and parental roles. Conclusion We found significant variation in criteria used for assessment of patient capacity, delivery of information used to obtain assent and documentation of the assent process. While we acknowledge that individual children, settings and jurisdictions may require different approaches to obtaining assent, there should be agreement on important principles to be followed with resulting common guidance on assessing capacity, delivering information and documentation of the assent process for publication. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:When Should “Riskier” Subjects Be Excluded from Research Participation?*Dave Wendler** (bio)AbstractThe exclusion of potential subjects based on increased risks is a common practice in human subjects research. However, there are no guidelines to ensure that this practice is conducted in a systematic and fair way. This gap in the literature and regulations is addressed by a specific account of a “condition on inclusion risks” (CIR), a condition under (...) which potential subjects should be excluded from research on the basis of increased risks. This account provides a general framework for assessing standard exclusions as well as more controversial ones such as the exclusion of pregnant women and women of childbearing potential from certain types of research.The exclusion of potential subjects on the basis of increased risks is a common and, in most instances, noncontroversial practice in human subjects research. Investigators routinely exclude potential subjects with reduced kidney function, bleeding disorders, and allergies to the drugs under investigation. Surprisingly, this use of exclusion criteria takes place in the absence of any explicit guidelines. In the present paper, I attempt to fill this gap in the literature and regulations by offering a specific account of the conditions under which potential subjects should be excluded from research on the basis of increased risk. This account serves two purposes.First, subjects who are excluded on the basis of increased risk are prevented from making their own enrollment decisions. Therefore, it is important to ensure, in spite of the broad range of potential subjects and the varied reasons for excluding them, that potential subjects are excluded in [End Page 307] a systematic and fair way. Second, certain instances of subject exclusion, most notably the exclusion of pregnant women and women of childbearing potential, raise more difficult issues. By providing a general framework for assessing the exclusion of potential subjects based on increased risks, the present analysis covers these cases as well and, thus, offers a solution to one of the thornier ethical dilemmas facing investigators and IRBs today.Briefly, I argue that standard exclusion practices suggest that whenever two groups of potential research subjects offer the same opportunity for scientific and individual benefit, but different levels of risk, the group that would introduce greater risks should be excluded. With this framework in place, I consider potential subjects, such as men and women of child-parenting potential, whose research participation introduces increased risks to third parties. I argue that the present approach is justified, not because it reduces harms to specific individuals, but because it reduces aggregate harms. Therefore, it should be applied to all riskier potential subjects regardless of who faces the risks in question. After defending this approach, I consider several objections.First, I argue that the present approach is not paternalistic; the exclusions it calls for are not justified by what is thought to be in the best interests of the individuals excluded. Rather, the argument is that these exclusions minimize the aggregate harm of human subjects research. In addition, the present approach does not violate the obligation of researchers to respect subject autonomy because it does not reduce the number of potential subjects who are given the opportunity to enroll in a particular protocol. Finally, the exclusions are consistent with reasonable side constraints on attaining the goals of research.“Riskier” SubjectsWhen it comes to evaluating risks, most guidelines on human subjects research stipulate simply that the risks entailed must be reasonable given the potential for benefit. The Australian National Health and Medical Research Council’s guidelines, for instance, require only that “the investigator... must be satisfied that the possible advantage to be gained from the work justifies any discomfort or risk involved” (ANMRC 1992, Clause 3). To determine whether the risks of a protocol are justified, one sums the risks of the various procedures in the protocol, whatever those procedures may be, and compares the result to the procedures’ potential for benefit. This evaluation of risks assumes that the aggregate risks of a [End Page 308] given protocol are fixed and thus will not help to determine whether and when the risks of particular protocols should be reduced by excluding riskier subjects. The United States Department of Health... (shrink)

Since children are considered incapable ofgiving informed consent to participate inresearch, regulations require that bothparental permission and the assent of thepotential child subject be obtained. Assent andpermission are uniquely bound together, eachserving a different purpose. Parentalpermission protects the child from assumingunreasonable risks. Assent demonstrates respectfor the child and his developing autonomy. Inorder to give meaningful assent, the child mustunderstand that procedures will be performed,voluntarily choose to undergo the procedures,and communicate this choice. Understanding theelements of informed consent (...) has been theparadigm for assessing capacity to give assent.This method leaves the youngest, leastcognitively mature children vulnerable towaiver of assent and forced researchparticipation. Voluntariness can also becompromised by the influence of authorityfigures who can exert undue influence andcoerce children to participate in research. This paper discusses factors that may influencethe decision to give assent/permission,potential parent-child conflict in theassent/permission process and how it isresolved, and potential parental undueinfluence on research participation. Theseissues are illustrated with quotations drawnfrom a larger qualitative study of parentalpermission and child assent (data notpresented). We suggest a developmentalapproach, viewing assent as a continuum rangingfrom mere affirmation in the youngest childrento the equivalent of the informed consentprocess in the mature adolescent. (shrink)

For paediatric medicine to advance, research must be conducted specifically with children. Concern about poor recruitment has led to debate about payments to child research participants. Although concerns about undue influence by such ‘compensation’ have been expressed, it is useful to determine whether children can relate the time and inconvenience associated with participation to the value of payment offered. This study explores children's ability to determine fair remuneration for research participation, and reviews payments to children participating in (...) research. Forty children were interviewed before outpatient visits at two London Hospitals: Great Ormond Street Children's Hospital and the Whittington Hospital District General Hospital. Children were asked to value their involvement in two hypothetical research scenarios – the first an ‘additional blood sample’, the second also involving daily oral oil capsules taken for a fortnight before further venesection. Background knowledge about familiarity with money, and experience with hospitalisation was assessed. The mean valuation of involvement in the second scenario (£13.18) was higher than in the first (£2.84) (p<0.001). This higher valuation persisted when children were categorised into groups ‘aged 12+’ and ‘below 12’. Those undergoing a blood test on the day placed a higher valuation on participation in the second scenario (£10.43, £21.67, p=0.044). These children aged 8–16 demonstrated the capacity to discern a fair valuation for participation in medical research. The monetary sums are influenced by the time and inconvenience involved in the research, and by the extent of recent experience with hospital procedures. The authors review current ethical thinking regarding payments to child research participants and suggest that a fair wage model might be an ethically acceptable way to increase participation of children in 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)

ObjectiveThe goal of the study was to explore the relationship between parent–children relationships related to using the internet among kids and potentially associated factors.Materials and MethodsA sample of 1.216 Vietnamese students between the ages of 12 and 18 agreed to participate in the cross-sectional online survey. Data collected included socioeconomic characteristics and internet use status of participants, their perceived changes in relationship and communication between parents and children since using the internet, and parental control toward the child’s internet use. (...) An Ordered Logistic Regression was carried out to determine factors associated with parent–children relationship since using the internet.ResultsThe characteristics of the relationship between children and their parents since using the Internet were divided into three levels: deterioration, stability, and improvement. The topics that children most often communicate with their parents include learning, housework, and future directions. Two-way interactive activities, such as supporting parents to use the Internet, have a positive impact on the parent–child relationship. Stubborn parental control, such as establishing rules about contact or allowing Internet access and setting up global positioning system to track negatively affecting parent–child relationships.ConclusionFindings indicated that changes in the quality of the parent–child relationship were self-assessed by participants regard to kids’ internet use, especially in the COVID-19 epidemic context. Educational campaigns and programs to raise awareness of parents as to the dangers and negative influences that their children may encounter online, psychology of children’s behaviors and effects of different responding strategies are recommended. (shrink)

This essay reflects on arguments by Paul Ramsey, in The Patient as Person: Explorations in Medical Ethics (1970) and elsewhere, that continue to challenge policy‐makers and those doing clinical and translational research involving children. Ramsey argued that parents cannot morally authorize their child's participation in research unless the research is designed to benefit the child. He acknowledged that abiding by this position could have adverse impacts on improving child health, and he concluded, in a 1976 Hastings (...) Center Report piece, that researchers must “sin bravely.” Many philosophers and theologians, including Richard McCormick, have argued against Ramsey. The Ramsey‐McCormick debate played out in the bioethics literature and, by invitation, at the deliberations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was tasked with developing an ethics framework and policies for human subjects protections. Although in its final recommendations, the commission sided with McCormick, the strict limitations on risks and harms to which a child can be exposed were clearly influenced by Ramsey. (shrink)

The United Nations Convention on the Rights of the Child sets out the rights to which all children should have access. Included in the Convention is children’s right to participate and have a say in matters affecting them. This right is equally applicable within a research context as it is in children’s everyday lives. This desk-top study reviews published ethics guidelines and university ethics documents associated with research involving children in school contexts, to determine the presence of children’s (...) class='Hi'>participation rights. It draws attention to how growing understandings of children’s participation rights, and the ethical issues associated with these, are inadequately encompassed within ethics guidelines and documents. (shrink)

This study explores the development of the interactional competence of an 8-year-old, Japanese learner of English over three cooking sessions with native speakers of English at her home during her period of residence in Australia. The study draws upon Vygotsky’s zone of proximal development in order to elucidate the L2 child’s process of acquiring interactional competence in this unfamiliar social practice. The analysis reveals marked changes in the child’s participation pattern over time, moving from making relevant minimal (...) responses to more initiated, and autonomous participation. The child recycled some of the interlocutors’ utterances from the previous sessions, showing that the earlier cooking sessions provided her with a linguistic challenge and became a resource of language learning for her. She also made use of a textual resource as a scaffold to move toward more autonomous participation. In addition, the role of the recipe became less central as her participation became increasingly more independent. (shrink)

Decision making for children who suffer abusive head trauma invokes multiple ethical considerations. The degree to which parents are permitted to participate in decision making after the injury has occurred is controversial. In particular, in this issue of The Journal of Clinical Ethics, Grigorian and colleagues raise concerns about the potential for conflict of interest in end-of-life decision making if the parents are facing criminal charges that could be escalated if the child dies. There are additional concerns about the (...) parents’ capacity to make decisions that are best for the child, given that the injury occurred. We argue that there are important reasons not to exclude parents from the decision-making process and that, with appropriate safeguards in place, parents are integral to determining what is best for the child. (shrink)

This article discusses whether a child can and should be engaged as a co-researcher on moral and epistemological grounds. Selected research literature has been used to illustrate various approaches to the issue of children's participating as co-researchers in social research. By exploring the predicament of childhood and the meaning of the concept ‘research’, we attempt to clarify the necessary conditions for a person to qualify as a researcher and for an activity to qualify as research. We then look at (...) the extent to which the concept of ‘child’ fits within these frames. (shrink)

Emotional development is one of the largest and most productive areas of psychological research. For decades, researchers have been fascinated by how humans respond to, detect, and interpret emotional facial expressions. Much of the research in this area has relied on controlled stimulus sets of adults posing various facial expressions. Here we introduce a new stimulus set of emotional facial expressions into the domain of research on emotional development—The Child Affective Facial Expression set (CAFE). The CAFE set features photographs (...) of a racially and ethnically diverse group of 2- to 8-year-old children posing for six emotional facial expressions—angry, fearful, sad, happy, surprised, and disgusted—and a neutral face. In the current work, we describe the set and report validity and reliability data on the set from 100 untrained adult participants. (shrink)

Using the metaphors body and voice and drawing on critical contributions on biopolitics, this article interrogates children’s participation rights in a knowledge culture of ‘evidencing’. With child welfare and protection practice as an empirical example, I analyse written assessment reports from a Swedish child welfare agency, all exemplifying how social workers evidence needs for protection and reasons for removing children from the home. I discuss how ‘evidencing’ equals a knowledge culture of seeing-believing and predicting-believing and the search (...) for visibly damaged bodies and underdeveloped minds. I furthermore problematise how such conceptualisation of evidencing foregrounds children’s ‘speaking’ bodies while silencing their voices. By showing these manifestations of evidencing, this critical contribution discusses some wider epistemic concerns for fields influenced by the knowledge cultures of ‘the evidence-based’. (shrink)

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer. Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites (...) in Canada (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their own research participation and cited factors that would influence their own decision to participate in, or to provide parental authorization for their child to participate in health research. Results: Completed questionnaire rates for AYAs and parents were 86 (46.5%) of 185 and 409 (65.2%) of 627, respectively. AYAs (n = 86 [67%]) and parents (n = 409 [85%]) cited that they would participate in research because it would help others. AYAs perceived pressure by their family and friends (16%) and their physician (19%). Having too much to think about at the time of accrual was an impediment to both groups (36% AYAs and 47% parents). The main deterrent for AYAs was that research would take up too much time (45%). Nonwhite parents (7 of 56 [12.5%]) were more apt to decline than white parents (12 of 32 [3.7%]; P < .01). Conclusions: AYAs identified time commitment and having too much to think about as significant impediments to research participation. Addressing these barriers by minimizing time requirements and further supporting decision-making may improve informed consent and impact on enrollment in trials. (shrink)

Background Research in children is essential for them to benefit from the outcomes of research but involvement must be weighed against potential harms. In many countries and circumstances, medical research legally requires parental consent until the age of 18 years, with poorly defined recommendations for assent prior to this. However, there is little research exploring how these decisions are made by families and the ethical implications of this. Aim To explore key ethical debates in decision-making for participation of children (...) and adolescents in a human papillomavirus (HPV) vaccine trial. Methods Semi-structured interviews were undertaken with Tanzanian girls (aged 9–16 years) who had participated in an HPV vaccine trial (n = 13), their parents or guardians (n = 12), and girls together with their parents (in paired parent-child interviews) (n = 6). The interviews were analysed using thematic analysis. Interview data came from a qualitative acceptability study undertaken as part of the Dose Reduction Immunobridging and Safety Study of Two Human Papillomavirus (HPV) Vaccines in Tanzanian Girls (DoRIS) trial. Results Girls and parents desired collaborative decision-making, with parents ultimately making the decision to consent. However, girls wanted a larger part in decision-making. Decisions to consent involved many people, including extended social networks, the trial team, media outlets and healthcare professionals and this resulted in conflicts to be negotiated. Deciding where to place trust was central in participants and parents considering decisions to consent and overcoming rumours about trial involvement. Conclusions Existing models of decision-making help to understand dynamics between parents, adolescents and researchers but neglect the important wider social impacts and the fundamental nature of trust. Children’s roles in discussions can be evaluated using the principles of consent: autonomy, freedom and information. Concepts such as relational autonomy help to explain mechanisms families use to negotiate complex consent decisions. Whilst interviewees supported the maintenance of legal parental consent, researchers must design consent processes centring the child to ensure that whole family decision-making processes are supported. (shrink)

BackgroundAll hospital trusts in Norway have clinical ethics committees. Some of them invite next of kin/patients to be present during the discussion of their case. This study looks closer at how parents of seriously ill children have experienced being involved in CEC discussions.MethodsTen next of kin of six seriously ill children were interviewed. Their cases were discussed in two CECs between April of 2011 and March of 2014. The main ethical dilemma was limitation of life-prolonging treatment. Health care personnel who (...) could elucidate the case were also present in the discussion. The interviewer observed each discussion and then interviewed the next of kin shortly after the meeting, following a structured interview guide.ResultsAll next of kin emphasized that it had been important for them to be present. They stressed the important role of the CEC chair and appreciated that their case was discussed in a systematic way. Some next of kin appreciated that the child’s impending death was discussed openly, and believed that this would facilitate their future grieving. Having had an opportunity to hear all the arguments behind the decision to be made would probably help them to accept the road ahead.All of them felt that they were taken seriously and listened to. They felt that they had added vital information to the discussion. All but one couple did not want any decision-making responsibility, some of them even worried that they might have influenced the discussion too much.ConclusionsNone of the next of kin felt that being present during the CEC discussion had been too heavy a burden. On the contrary, they claimed that their presence in a CEC discussion may add vital information to the discussion and may improve the quality of the decision. It is important that the CEC’s role is explained to them so they are well prepared for what to expect. They need to be followed up after the discussion. (shrink)

The greatest mandate which God entrusted to human beings since creation is keeping and sustaining the creation. Human beings are responsible towards making the creation glorify God the creator. Another important task is to bring forth other human beings—children—who will also become responsible towards creation in their adulthood. It means that the responsibility of humanity towards creation is continuous. Children are gifts from God through marriages and have to be reared to adulthood in order for them to become fully responsible (...) to God’s creation. This article examined the perceptions of church leaders and normal Christians towards child-rearing in both African traditional and Christian settings. Being guided by Ainsworth and Bowlby’s Attachment Theory, the article addressed the following questions: How is child-rearing understood and practiced in the research area? Is there any laziness in the rearing of children that hinders their proper development to adulthood? In response to these questions, a qualitative study was conducted at Isongole Ward, Ileje District, Songwe region in Tanzania. Interviews were conducted to eight research participants selected purposefully after their informed consent. Data were analyzed qualitatively to obtain themes which were the basis for the presentation and interpretation of findings. Results indicated that laziness to rear children properly was one of the major hindrances for children to realize their adulthood potentials in the future. The article suggests that to have an ethical church and ethical society, child-rearing basing on proper Christian foundation is of paramount importance. (shrink)