Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand the experiences and motivations of young people who took part in clinical trials. This is a qualitative interview study of 25 young people aged 10–23 who were invited to take part in clinical trials. Interviews were audio (...) or video recorded and analyzed using framework analysis. Young peoples' motivations were both personal benefit and helping others. Both incentives appeared to be more complex than expected. We introduce the terms “network of exchange” and “intergenerational solidarity” to describe these motivations. To improve recruitment, professionals should be more open about research opportunities, provide better information, and give young people feedback after the trial has ended. (shrink)

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positive agreement of some children, but not others, before enrolling them in research that does not offer a compensating potential for direct benefit? We argue that the scope of (...) children's research decision making should be based on the principles of respect for autonomy and nonmaleficence. These principles imply that the threshold for assent should be fixed at 14 years of age, and a dissent requirement should be adopted for all children in the context of nonbeneficial research. (shrink)

Federal guidelines require that informed consent be obtained from participants when they are enrolled in a research study. When conducting research with children, the guidelines utilize the term permission to describe parents' agreement to enroll their children in a study. The basic components of consent and permission are well described and identical, with the exception of the person for whom the decision to participate is being made. Beyond permission, when enrolling minor participants in research, affirmative agreement to participate in research (...) or assent must be obtained from the child participants themselves. The concept of children's assent to research, however, is poorly defined, resulting in inconsistency in its pursuit and, consequently, in its utility. The interface between cognitive development, emotional, and social development must be examined as it pertains to this special situation of decision making. For this process to meaningfully protect minors, the assent process must be clarified, decisions regarding parental veto power must be more convincingly justified, and researchers must be better educated and held accountable for the valid execution of this process. Strategies for implementing the assent process more effectively are presented. (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.

Objective: The objective of the current study was to maximise the amount of information children and adolescents understand about the risks and benefits associated with participation in a biomedical research study.Design: Participants were presented with one of six hypothetical research protocols describing how to fix a fractured thigh using either a “standard” cast or “new” pins procedure. Risks and benefits associated with each of the treatment options were manipulated so that for each one of the six protocols there was either (...) a correct or ambiguous choice.Participants and setting: Two hundred and fifty one children, ages 6–15 , and 237 adults were interviewed while waiting for a clinic appointment at the Hospital for Sick Children.Results: Using standardised procedures and questionnaires, it was determined that most participants, regardless of age group, were able to understand the basic purpose and procedures involved in the research, and most were able to choose the “correct” operation. The younger children, however, showed an overall preference for a cast operation, whereas the older participants were more likely to choose the pins.Conclusions: By creating age appropriate modules of information, children as young as six years can understand potentially difficult and complex concepts such as the risks and benefits associated with participation in biomedical research. It appears, however, that different criteria were used for treatment preference, regardless of associated risks; older participants tended to opt for mobility whereas younger participants stayed with the more familiar cast operation. (shrink)

“Neurodiversity” is associated with the struggle for the civil rights of all those diagnosed with neurological or neurodevelopmental disorders. Two basic approaches in the struggle for what might be described as “neuro-equality” are taken up in the literature: There is a challenge to current nosology that pathologizes all of the phenotypes associated with neurological or neurodevelopmental disorders ); there is a challenge to those extant social institutions that either expressly or inadvertently model a social hierarchy where the interests or needs (...) of individuals are ranked relative to what is regarded as properly functioning cognitive capacities. In this paper, we explore some of the reasons justifying which make it an important tool for achieving greater neuro-equality, while still recognizing its limitations for achieving this goal. Particularly, we explore how an appeal to functionality and neurological diversity can support a re-seeing of at least certain forms of ASD. (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)

Conventional and well-established guidelines for the ethical conduct of clinical research are necessary but not sufficient for addressing research dilemmas related to public health research. There is a particular need for a public health ethics framework when, in the face of an epidemic, research is urgently needed to promote the common good. While there is limited experience in the use of a public health ethics framework, the value and potential of such an approach is increasingly being appreciated. Here we use (...) two examples of adolescent women as potential candidates for participation in microbicide trials to illustrate how ethical decisions for public health research can be enhanced by drawing on both traditional research ethics guidance, and the emerging framework for public health ethics. (shrink)

Background: Knowledge about assent or dissent of children to non-therapeutic research is poor.Objectives: To assess sociodemographic characteristics in healthy children and adolescents who were invited to participate in non-therapeutic research, to evaluate their motives for assent or dissent and their understanding of the information given.Methods: A total of 1281 healthy children and adolescents six to sixteen years of age were invited to participate in a non-therapeutic study and a questionnaire.Results: Assenting children were motivated by a desire to help sick children (...) and to gain experience with participating in a research study . Dissenting children made their decision because of worries about having a blood or a urine sample taken or because of worries about a doctor’s examination . Fewer children in the assent group than in the dissent group worried about the doctor’s examination . In the assent and dissent group, 568 and 343 children, respectively, said they were able to understand some or all of the written information , and 650 and 330 , respectively, were able to understand some or all of the verbal information .Conclusions: Sociodemographic characteristics may not influence healthy children’s decision to volunteer for non-therapeutic research. Assenting children have altruistic and educational motives, whereas worries about procedures may cause children to dissent. A great majority of school children and adolescents feel capable of understanding and giving assent or dissent to non-therapeutic research. (shrink)

BackgroundBiobanking biospecimens and consent are common practice in paediatric research. We need to explore children and young people’s (CYP) knowledge and perspectives around the use of and consent to biobanking. This will ensure meaningful informed consent can be obtained and improve current consent procedures.MethodsWe designed a survey, in co-production with CYP, collecting demographic data, views on biobanking, and consent using three scenarios: 1) prospective consent, 2) deferred consent, and 3) reconsent and assent at age of capacity. The survey was disseminated (...) via the Young Person’s Advisory Group North England (YPAGne) and participating CYP’s secondary schools. Data were analysed using a qualitative thematic approach by three independent reviewers (including CYP) to identify common themes. Data triangulation occurred independently by a fourth reviewer.ResultsOne hundred two CYP completed the survey. Most were between 16–18 years (63.7%, N = 65) and female (66.7%, N = 68). 72.3% had no prior knowledge of biobanking (N = 73).Acceptability of prospective consent for biobanking was high (91.2%, N = 93) with common themes: ‘altruism’, ‘potential benefits outweigh individual risk’, 'frugality', and ‘(in)convenience’.Deferred consent was also deemed acceptable in the large majority (84.3%, N = 86), with common themes: ‘altruism’, ‘body integrity’ and ‘sample frugality’. 76.5% preferred to reconsent when cognitively mature enough to give assent (N = 78), even if parental consent was previously in place. 79.2% wanted to be informed if their biobanked biospecimen is reused (N = 80).ConclusionProspective and deferred consent acceptability for biobanking is high among CYP in the UK. Altruism, frugality, body integrity, and privacy are the most important themes. Clear communication and justification are paramount to obtain consent. Any CYP with capacity should be part of the consenting procedure, if possible. (shrink)

This narrative review summarizes the empirical literature on children's competence for consent and assent in research and treatment settings. Studies varied widely regarding methodology, particularly in the areas of participant sampling, situational context studied (e.g., psychological versus medical settings), procedures used (e.g., lab-based vs. real-world approaches), and measurement of competence. This review also identified several fundamental dilemmas underlying approaches to children's informed consent. These dilemmas, including autonomy versus best interests approaches, legal versus psychological or ethical approaches, child- versus family-based approaches, (...) and approaches that emphasize consent versus those that emphasize assent, have implications for the measurement of children's competence and interpretation of findings. Recommendations for future research in the area of children's informed consent include the use of diverse samples and control groups, development of multidimensional and standardized measures of competence, utilization of observational methods and longitudinal designs, examination of noncognitive aspects of children's competence, and comparison of children's competence for treatment and research decisions. (shrink)

As children and adolescents receive increased research attention, ethical issues related to obtaining informed consent for pediatric intervention research have come into greater focus. In this article, we conceptualize parent permission and child assent within a goodness-of-fit framework that encourages investigators to create consent procedures “fitted” to the research context, the child's cognitive and emotional maturity, and the family system. Drawing on relevant literature and a hypothetical case example, we highlight four factors investigators may consider when constructing consent procedures that (...) best reflect participants' rights, concerns, and well-being: (a) the child's current assent capacity and the likely impact of study information on the child's mental and physical development, (b) parents' understanding of their child's treatment needs and distinctions between treatment and clinical trials research, (c) the family's history of shared decision making, and (d) the child's strivings for autonomy within the context of their parents' duty to make decisions in the child's best interest. (shrink)

An informed consent and voluntary assent in biomedical research with adolescents is contingent on a variety of factors, including adolescent and parent perceptions of research risk, benefit, and decision-making autonomy. Thirty-seven adolescents with asthma and their parents evaluated a high or low aversion form of a pediatric asthma research vignette and provided an enrollment decision; their perceptions of family influence over the participation decision; and evaluations of risk, aversion, benefit, and burden of study procedures. Adolescents and their parents agreed on (...) research participation decisions 74% of the time, yet both claimed ultimate responsibility for the participation decision. Both rated most study procedures as significantly more aversive than risky. Parents were more likely to rate aspects of the hypothetical study as beneficial and to provide higher risk ratings for procedures. Disagreements concerning research participation decisions and decision-making autonomy have implications for the exercise of voluntary assent in biomedical research. (shrink)

The treatment of life-threatening illnesses in childhood is replete with ethical issues and with clinical issues that have ethical implications. The central issues are those involved with a child's participation in the decision-making process and with communication of information about the illness and treatments to children. This article examines the questions of patient autonomy and of parental responsibility and prerogative in the context of pediatric oncology. Included in this examination of the ethical dimensions of pediatric life-threatening illness is a discussion (...) of the many related aspects involved, including medical, cultural, psychosocial, legal, and developmental. A multidimensional approach that considers the ways in which these multiple aspects interact with one another, and which focuses on establishing a strong working alliance between the health care team and the pediatric patient's family, can help to avoid or resolve potential ethical and clinical conflicts. (shrink)

BackgroundBariatric surgery for children and adolescents is becoming widespread. However, the evidence is still scarce and of poor quality, and many of the patients are too young to consent. This poses a series of moral challenges, which have to be addressed both when considering bariatric surgery introduced as a health care service and when deciding for treatment for young individuals. A question based (Socratic) approach is applied to reveal underlying moral issues that can be relevant to an open and transparent (...) decision making process.DiscussionA wide range of moral issues with bariatric surgery for children and adolescents is identified in the literature. There is a moral imperative to help obese minors avoiding serious health problems, but there is little high quality evidence on safety, outcomes, and cost-effectiveness for bariatric surgery in this group. Lack of maturity and family relations poses a series of challenges with autonomy, informed consent, assent, and assessing the best interest of children and adolescents. Social aspects of obesity, such as medicalization, prejudice, and discrimination, raise problems with justice and trust in health professionals. Conceptual issues, such as definition of obesity and treatment end-points, present moral problems. Hidden interests of patients, parents, professionals, industry, and society need to be revealed.SummaryPerforming bariatric surgery for obese children and adolescents in order to discipline their behavior warrants reflection and caution. More evidence on outcomes is needed to be able to balance benefits and risks, to provide information for a valid consent or assent, and to advise minors and parents. (shrink)

Definition of the problem: Medical research with children, especially non-therapeutic research, requires particular consideration. In the current situation this kind of research is not clearly regulated by law in Germany. This entails practical problems in evaluating clinical studies from an ethical point of view. Arguments and conclusion: To develop a new policy framework the international ethical discussion is reviewed. The article analyzes the historical development of research with minors from an ethical perspective, the notion of minimal risk, criteria for evaluating (...) risk and harm in research, consent and assent procedures, and the participation of parents and children in the planning of clinical studies. A list of proposals for minimal standard in ethical regulation of research with minors is developed. (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)