UNASSIGNED: This study assesses how pediatric assent is conceptualized and justified within the therapeutic context. Pediatric ethicists generally agree that children should participate in medical care decisions in developmentally appropriate ways. Much attention has been paid to pediatric assent for research participation, but ambiguities persist in how assent is conceptualized and operationalized in the therapeutic context where countervailing considerations such as the child\'s best interest and parental permission must also be weighed.
UNASSIGNED: Searches were conducted in 11 databases including PubMed, Embase, Cochrane Library, and Web of Science. Articles published between 2010 and 2020 were screened in COVIDENCE for meeting each of four criteria: (1) focusing on pediatric assent, (2) focusing on clinical care, (3) including normative claims, and (4) containing substantive statements about the meaning of pediatric assent. Full texts were abstracted for (1) operational definitions of assent, (2) discussion of the temporal nature of assent, (3) description of the concept of \"understanding,\" and (4) ethical justifications for soliciting assent. These excerpts were coded and code patterns formed themes presented in the results.
UNASSIGNED: The final analytic data set contained 29 articles. Analysis yielded three key themes. First, valid assent varies by treatment, population (e.g., younger versus older), and geographic/cultural context. Second, assent represents two distinct longitudinal processes: One involves eliciting preferences over a disease course or care episode; the other focuses on children\'s developmental maturation. Third, ethical justifications for assent draw variously on instrumental and intrinsic reasons, but often remain ambiguous.
UNASSIGNED: There is widespread agreement that assent is morally valuable, but there remain substantial ambiguities or disagreements about its meaning, process, and ethical justification.

Precision medicine is an emergent medical paradigm that uses information technology to inform the use of targeted therapies and treatments. One of the first steps of precision medicine involves acquiring the patient\'s informed consent to protect their rights to autonomous medical decision-making. In pediatrics, there exists mixed recommendations and guidelines of consent-related practices designed to safeguard pediatric patient interests while protecting their autonomy. Here, we provide a high-level, clinical primer of (1) ethical informed consent frameworks widely used in clinical practice and (2) promising modern adaptations to improve informed consent practices in pediatric precision medicine. Given the rapid scientific advances and adoption of precision medicine, we highlight the dual need to both consider the clinical implementation of consent in pediatric precision medicine workflows as well as build rapport with pediatric patients and their substitute decision-makers working alongside interdisciplinary health teams.

Medical ethics is relevant to the clinical practice of allergy and immunology regardless of the type of patient, disease state, or practice setting. When engaging in clinical care, performing research, or enacting policies on the accessibility and distribution of healthcare resources, physicians regularly make and justify decisions using the fundamental principles of medical ethics. Thus, knowledge of these principles is paramount for allergists/immunologists. To date, there has been a shortage of medical ethics research in allergy and immunology. This review describes this scarcity, highlights publication trends over time, and advocates for additional support for research and training in medical ethics with a focus on topics germane to the practice of allergy and immunology.

Pediatric surgeons need to learn to give as much importance to the ethical approach as they have been giving to the systemic methodology in their clinical approach all along. The law of the land and the governmental rules also need to be kept in mind before deciding the final solution. They need to always put medical problems in the background of ethical context, reach a few solutions keeping in mind the available resources, and apply the best solution in the interest of their pediatric patients.

Ethical dilemmas routinely occur in the clinical practice of allergy and immunology. These ethical questions stem from the range of conditions and the different populations cared for by Allergists/Immunologists. Hence, medical ethics is not an esoteric concept, but a practical skill physicians exercise regularly. Moreover, an ethics-centered approach may improve patient safety and outcomes. This article describes key principles of bioethics and illustrates an ethical framework that physicians can use in their conversations with patients. Utilization of this ethical framework is demonstrated through applying it to 4 unique clinical scenarios encountered by Allergists/Immunologists from different practice settings. The ethical framework for allergy and immunology is a technique to navigate ethically complex decisions that arise in routine clinical practice.

Arranging assent opportunities is an increasingly common strategy for involving clients in therapeutic decisions within behavior analysis. Recent behavior-analytic articles have helped create a basic behavioral definition and conceptualization of assent, but much more guidance is needed for practitioners and researchers interested in embedding assent into their practices. The purpose of this article is to advance the conceptualization and understanding of assent and assent practices by refining previous definitions and conceptualizations of assent and providing six essential considerations for embedding assent into practice. The six considerations consist of determining the applicability and feasibility of assent, assessing assent-related skills, arranging assent procedures and teaching assent-related skills, arranging fair choices, selecting opportunities to assess assent, and informally assessing assent. Following the discussion of the considerations for assent practices, we issue a call for specific topics of research on assent.

UNASSIGNED: The information provided to potential trial participants plays a crucial role in their decision-making. Printed participant information sheets for trials have received recurrent criticism as being too long and technical, unappealing and hard to navigate. An alternative is to provide information through multimedia (text, animations, video, audio, diagrams and photos). However, there is limited evidence on the effects of multimedia participant information on research recruitment rates, particularly in children and young people.
UNASSIGNED: The study objectives were as follows: 1. to develop template multimedia information resources through participatory design, for use when recruiting children and young people to trials 2. to evaluate the multimedia information resources in a series of Studies Within A Trial, to test their effects on recruitment and retention rates, and participant decision-making, by comparing the provision of multimedia information resources instead of printed participant information sheets, and comparing the provision of multimedia information resources in addition to printed participant information sheets.
UNASSIGNED: Two-phase study: 1. multimedia information resources development including qualitative study; user testing study; readability metrics; enhanced patient and public involvement 2. multimedia information resources\' evaluation comprising Studies Within A Trial undertaken within host trials recruiting children and young people.
UNASSIGNED: United Kingdom trials involving patients aged under 18.
UNASSIGNED: Development phase: n = 120 (children and young people, parents, clinicians, trial personnel). Evaluation phase: n = 1906 (children and young people being asked to take part in trials).
UNASSIGNED: Multimedia information resources (comprising text, audio, \'talking heads\' video, trial-specific and trial-generic animations). Printed participant information sheets.
UNASSIGNED: Primary outcome: trial recruitment rate comparing multimedia information resource-only with printed participant information sheet-only provision. Secondary outcomes: trial recruitment rate comparing combined multimedia information resource and printed participant information sheet with printed participant information sheet-only provision; trial retention rate; quality of participant decision-making. Results for each trial were calculated and combined in a two-stage random-effects meta-analysis.
UNASSIGNED: Phase 1 generated two multimedia information resource templates: (1) for children aged 6-11 years; (2) for children aged 12-18 years and parents. In the Phase 2 Studies Within A Trial the multimedia information resources improved trial recruitment, when compared to printed information alone [odds ratio (OR) = 1.54; 95% confidence interval (CI) 1.05 to 2.28; p = 0.03; I2 = 0%]. When printed participant information sheet-only provision was compared to combined multimedia information resource and printed participant information sheet provision, there was no effect on trial recruitment (OR = 0.89; 95% CI 0.53 to 1.50; I2 = 0%). There were no differences between multimedia information resource and printed participant information sheet on trial retention or participant decision-making quality. In a study within a hypothetical trial setting, multimedia information resource-only provision produced higher ratings of \'information was easy to understand\' (Z = 3.03; p = 0.003) and \'I had confidence in decision-making\' (Z = 2.00; p = 0.044) than printed participant information sheet-only provision.
UNASSIGNED: It was not possible to include data from three Studies Within A Trial in the meta-analysis due to limited sample size, and questionnaire return rates were low, which reduced the strength of the findings.
UNASSIGNED: Use of multimedia information increased the rate of recruitment to trials involving children and young people compared to standard patient information sheets.
UNASSIGNED: There should be further evaluation of the effects of multimedia information on recruitment to trials involving children and young people. It would be valuable to assess any impacts of multimedia information resources on communication between trial recruiters, children and young people, and parents.
UNASSIGNED: This trial is registered as TRECA ISRCTN 73136092 and Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT 97).
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 14/21/21) and is published in full in Health and Social Care Delivery Research; Vol. 11, No. 24. See the NIHR Funding and Awards website for further award information.
Clinical trials are important to National Health Service care, but it can be difficult to recruit enough people. We do not know enough about how to improve recruitment, especially when trying to recruit children and young people. People are normally told about a trial through printed information, which is often long and complex. Multimedia information (text, audio, cartoons and video) might be a better way of telling people. It is important to test whether multimedia interventions can help. One way of doing this is to run a ‘Study Within A Trial’ where people receive information in different ways. We created two multimedia interventions, one for parents and young people being asked for consent, and a simpler one for younger children. Some content applied to all trials, and some about the specific trial people were being asked to consider. We designed these by working closely with children and young people, parents and healthcare staff. We tested the multimedia information in six trials (although only three gave us enough data). Children, young people and their parents saw either standard printed information or our multimedia information. We then collected data on their decision-making, trial recruitment and whether people stayed in the trial. Children and young people who saw multimedia information were more likely to be recruited than those who received standard printed information. Once recruited to a trial, people given multimedia or printed information were similarly likely to remain in the trial. People’s views on multimedia and printed information were also similar, but this finding could have been affected by small numbers of people returning questionnaires. Our study provides evidence that multimedia information can be used in trials with children and young people and that it increases the number of people who agree to take part, but further work is needed.

During therapeutic treatment and research in psychology and related fields, informed consent by the client or participant is required when they are over the age of 18; assent is required when a client or participant is under the age of 18 or a conserved adult. During both research and treatment, behavior analysts often work with neurodiverse individuals who have language deficits, and these clients may require unique assent procedures. This article will outline reasons behavior-analytic research and therapy require field-specific assent procedures. Furthermore, the goals of research and therapy are different and therefore assent may need to differ as well. This article will also argue that therapeutic assent during behavior-analytic treatment requires a unique set of guidelines and procedures that may differ from the behavior-analytic research.

Research involving pediatric populations has important ethical and regulatory considerations. As children generally cannot consent to research, there are special protections put in place to ensure that the decisional vulnerability is protected, including parental permission and often the child\'s assent. Assent is an ethically important part of the research because it allows the child to participate in the process of agreeing to research, develop their autonomy, and express their values. This article explores a case where the child and parent disagree about the child\'s participation. In doing so, the regulatory requirements of pediatric research are outlined and the process and product of obtaining assent from a minor is described.

Biobanking 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.
We 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.
One 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).
Prospective 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.