The importance of applying the statement of assent to children and adolescents: a qualitative study.

OBJECTIVES: To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation. METHODS: This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis. RESULTS: Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study. CONCLUSIONS: The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.

The Role of Formal Policy to Promote Informed Consent of Psychotropic Medications for Youth in Child Welfare Custody: A National Examination.

Active participation of youth and surrogate decision-makers in providing informed consent and assent for mental health treatment is critical. However, the procedural elements of an informed consent process, particularly for youth in child welfare custody, are not well defined. Given calls for psychotropic medication oversight for youth in child welfare custody, this study proposes a taxonomy for the procedural elements of informed consent policies based upon formal and informal child welfare policies and then examines whether enacted state formal policies across the United States endorsed these elements. A sequential multi-method study design included: (1) semi-structured interviews with key informants (n = 58) primarily from state child welfare agencies to identify a taxonomy of procedural elements for informed consent of psychotropic medications and then (2) a legislative review of the 50 states and D.C. to characterize whether formal policies endorsed each procedural element through February 2022. Key informants reported five procedural elements in policy, including how to: (1) gather social and medical history, (2) prescribe the medication, (3) authorize its use through consent and youth assent, (4) notify relevant stakeholders, and (5) routinely review the consenting decision. Twenty-three states endorsed relevant legislation; however, only two states specified all five procedural elements. Additionally, the content of a procedural element, when included, varied substantively across policies. Further research and expert consensus are needed to set best practices and guide policymakers in setting policies to advance transparency and accountability for informed consent of mental health treatment among youth in child welfare custody.

The importance of applying the statement of assent to children and adolescents: a qualitative study / La importancia de la aplicación del término de consentimiento para niños y adolescentes: un estudio cualitativo / A importância da aplicação do termo de assentimento para crianças e adolescentes: um estudo qualitativo

Objective. To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation. Methods. This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis. Results. Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study. Conclusion. The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.

Objetivo. describir la importancia del Formulario de Consentimiento Informado para los niños y adolescentes invitados a participar en un estudio clínico aleatorizado y sus principales reacciones a su explicación. Métodos. se trata de una investigación exploratoria descriptiva con abordaje cualitativo, realizada con 17 niños y adolescentes, quienes fueron invitados a participar de un estudio clínico en el área de oncología en un hospital ubicado en Río de Janeiro (Brasil). A los datos se les realizó análisis temático. Resultados. Luego de la interpretación de los datos, se generaron 2 unidades temáticas: la firma del formulario de consentimiento y la comprensión del estudio. Los niños y adolescentes entendieron las etapas del estudio contenidas en la firma del Término de Asentimiento y se interesaron, haciendo preguntas para aclarar sus dudas sobre la investigación. Conclusión. El consentimiento informado era importante para que los participantes entendieran la investigación y tuvieran autonomía sobre su participación. Al potenciar el protagonismo de los niños y adolescentes en el proceso de investigación, recomendamos que debe fomentarse su uso en los estudios con población pediátrica.

Objetivo. Descrever a importância do Termo de Assentimento para crianças e adolescentes convidados a participar de um estudo clínico e suas principais reações quanto à explicação do mesmo. Métodos. Trata-se de uma pesquisa do tipo descritiva exploratória com abordagem qualitativa, realizada com 17 crianças e adolescentes, que foram convidados a participar de um estudo clínico na área da oncologia em um hospital localizado no Rio de Janeiro (Brasil). Os dados foram analisados empregando-se a análise temática. Resultados. Após a interpretação dos dados, foram geradas 2 unidades temáticas: a assinatura do termo de assentimento em que os participantes se sentiram protagonistas frente a possibilidade de expressarem a concordância ou não em participar da pesquisa, e a compreensão sobre o estudo quando elas mostraram que entenderam as etapas do estudo fazendo perguntas pertinentes para esclarecer suas dúvidas. As crianças e adolescentes compreenderam as etapas do estudo que constavam no Termo de Assentimento e tiveram interesse, fazendo perguntas para esclarecer suas dúvidas com relação à pesquisa. Conclusão. O termo de assentimento foi importante para os participantes compreenderem sobre a pesquisa e para terem autonomia sobre sua participação. Por potencializar o protagonismo de crianças e adolescentes no processo de pesquisar conclui-se que seu uso em estudos que envolvem a população pediátrica deve ser incentivado.

Construção e aplicabilidade de um termo de assentimento em pesquisa em nutrição com crianças hospitalizadas em tratamento oncológico / Construction and applicability of a term of consent in nutrition research with children hospitalized for oncological treatment

Objetivo: relatar a experiência na construção e aplicabilidade de um termo de assentimento livre esclarecido em uma pesquisa com crianças pré-escolares e escolares hospitalizadas para tratamento oncológico. Material e método: trata-se de um relato de experiência sobre a construção e aplicabilidade de um Termo de Assentimento Livre e Esclarecido lúdico para realização de um estudo sobre perfil nutricional e educação alimentar e nutricional de crianças em tratamento oncológico de um hospital público infantil em Santa Catarina-Brasil. Resultados: a construção e aplicabilidade do Termo de Assentimento Livre Esclarecido permitiu melhor compreensão da criança anterior à realização da pesquisa referente às etapas e fases da coleta dos dados do estudo, assim como os riscos e benefícios do mesmo. Foi possível à criança esclarecer suas dúvidas e participar ativamente do estudo. Foram convidadas para participar do estudo 13 crianças de ambos os sexos entre 5 ­ 12 anos de idade que estavam internadas no ambulatório de oncologia. Considerações Finais: adoção do Termo de Assentimento Livre Esclarecido Lúdico construído mostrou-se efetivo ao alcance do objetivo de sua utilização no contexto ético em pesquisa e avançou no sentido de despertar sobre potencialidade para além da pesquisa e, também, como recurso fundamental para o assentimento das crianças em situações específicas no processo de adoecimento e internação, possibilitando o exercício de direito e compreensão do que está sendo realizado durante seu tratamento.

Objective: report the experience in the construction and applicability of an informed term of consent in a survey of children hospitalized for cancer treatment. Material and method: experience report on the construction and applicability of a free and informed term of consent for conducting a study on the nutritional profile and food and nutrition education of children and adolescents undergoing cancer treatment at a public hospital in Santa Catarina, Brazil. Results: the construction and applicability of the informed term of consent allowed a better understanding of the child prior to conducting the research regarding the steps and phases of data collection, as well as its risks and benefits. It was possible for the child to clarify their doubts and actively participate in the study. Thirteen children of both sexes, aged between 5 - 12 years, hospitalized and in the oncology outpatient clinic, were invited to participate. Final considerations: adoption of the playful free and informed term of consent proved to be effective in reaching the objective of its use in the ethical research context and it has advanced in the sense of raising awareness of the potentiality beyond research, and also as a fundamental resource for the consent of children in specific situations in the illness and hospitalization process, enabling them to exercise their rights and understand what is happening during their treatment.

[Pediatric informed consent in medical care and research]. / Consentement éclairé de l'enfant.

Pediatric informed consent in medical care and research. The obligation to obtain informed consent from a patient prior to any care does not depend solely on the personal ethics of the practitioner. It is defined and framed by law. However, innumerable legal difficulties emanate from the simple fact that the subject is a child, a vulnerable person who must be protected, and that this protection is exercised under the aegis of the parental authority. If in most cases there is an alliance with the holders of parental authority, the views sometimes diverge. The article lists the most frequently observed cases in clinical practice and the way in which the french Public Health Code plans to solve them. Problems specific to research are discussed. Difficulties for consent about off-label prescribing are briefly exposed.

Consentement éclairé de l'enfant. L'obligation de recueillir le consentement éclairé du patient avant tout soin le concernant ne relève pas seulement de l'éthique personnelle du praticien. Elle est définie et encadrée par la loi. Cependant, des difficultés juridiques innombrables émanent du simple fait que le sujet est un enfant, personne vulnérable qu'il faut protéger, et que ladite protection s'exerce sous l'égide de l'autorité parentale. Si dans l'immense majorité des cas, il y a alliance avec les détenteurs de l'autorité parentale, il arrive que les points de vue divergent. Cet article recense les cas de figure les plus fréquemment observés en pratique clinique et la façon dont le code de la santé publique prévoit de les résoudre. Les problèmes spécifiques à la recherche et à la prescription hors autorisation de mise sur le marché sont succinctement abordés.

Using Maintenance of Certification as a Tool to Improve the Delivery of Confidential Care for Adolescent Patients.

STUDY OBJECTIVE: Providing adolescents with confidential health care results in better social and health outcomes. We sought to assess if a medical board Maintenance of Certification Part IV project could improve the delivery of confidential care to minor adolescent patients seen in outpatient primary care practices. DESIGN: Participating physicians reviewed 3 months of charts for patients ages 12-17 years seen for well visits during a baseline time period, and after 2 Plan, Do, Study, Act intervention cycles to assess if they had met confidentiality standards. Participating physicians additionally completed an assessment tool on personal and clinic practices related to confidentiality. SETTING: Nine academic and 3 private practice family medicine, pediatrics, and medicine-pediatrics sites. PARTICIPANTS: Forty-four physicians. INTERVENTIONS: Provider and staff deficits in knowledge of minor consent laws, resistance toward the idea of confidential care, and work flow issues around confidential screening were identified as primary barriers. Staff and provider trainings, scripts, and staff involvement in planning work flows were identified as key interventions. MAIN OUTCOME MEASURES: Improvement in confidentiality standards met during minor adolescent well visits. RESULTS: Participating physicians significantly increased the proportion of well visits in which they spent time alone with the patient (P = .001), explained minor consent laws (P < .001), and had the adolescent complete a confidential risk screening tool (P < .001), in addition to improving scores on their confidentiality assessment overall (P < .001). CONCLUSIONS: A medical board Maintenance of Certification Part IV project is an effective way to change physician practice and improve the delivery of confidential care to minor adolescents seen for well visits.

Ethics of Online Assent: Comparing Strategies to Ensure Informed Assent Among Youth.

Individuals, including youth, often participate in online research without understanding the characteristics of studies they have agreed to be part of. We assessed the impact of including questions as part of the assent process by randomizing 568 youth to one of three groups: (a) asking youth to only read study information and then indicate their willingness to participate, (b) requiring youth to answer two questions about the study's risks and voluntary nature as part of the assent process, and (c) requiring youth to answer seven questions. Participants in the two- and seven-question groups, compared with the no-question group, were less likely to complete the assent process but, among those who did complete it, were more likely to read and understand study information.

Self-Consent for HIV Prevention Research Involving Sexual and Gender Minority Youth: Reducing Barriers Through Evidence-Based Ethics.

This project examined the attitudes of sexual and gender minority youth (SGMY) toward guardian permission for a pre-exposure prophylaxis (PrEP) adherence trial and their preparedness to provide informed, rational, and voluntary self-consent. Sixty sexually active SGMY (ages 14-17) participated in online survey and asynchronous focus group questions after watching a video describing a PrEP adherence study. Youth responses highlighted guardian permission as a significant barrier to research participation, especially for those not "out" to families. Youth demonstrated understanding of research benefits, medical side effects, confidentiality risks, and random assignment and felt comfortable asking questions and declining participation. Reasoning about participation indicated consideration of health risks and benefits, personal sexual behavior, ability to take pills every day, logistics, and post-trial access to PrEP. Results demonstrate youth's ability to self-consent to age- and population-appropriate procedures, and underscore the value of empirical studies for informing institutional review board (IRB) protections of SGMY research participants.

Data research on child abuse and neglect without informed consent? Balancing interests under Dutch law.

According to the Declaration of Helsinki, participation of human subjects in medical research is only acceptable if subjects have given their consent. But in child abuse and neglect, many studies use a design in which subjects do not actively participate. Data in these studies are gathered from sources such as medical records or Child Protective Services. As long as such data are used anonymously, this does not interfere with individual privacy rights. However, some research is only possible when carried out with personally identifiable data, which could potentially be misused. In this paper, we discuss in which situations and under which conditions personal data of children may be used for a study without obtaining consent. In doing so, we make use of two recent studies, performed in our hospital, in which we encountered this issue. Both studies involved collecting personal data. After careful consideration, we decided not to ask informed consent; instead, we arranged for specific safeguards to protect the subject's and their parents' privacy as well as possible. CONCLUSION: Altogether, we conclude that our approach fits within the Dutch legal framework and seems a reasonable solution in situations in which individual privacy rights are at odds with the public interest of child abuse and neglect research. We argue that, although, in principle, data research is only acceptable after informed consent is obtained, the law should allow that, under specific circumstances and safeguards, this requirement is put aside to make research in the field of child abuse and neglect possible. WHAT IS KNOWN: • In principle, data research is only acceptable after informed consent is obtained.• In practice, this is not always feasible. WHAT IS NEW: • Under specific circumstances and safeguards, the informed consent requirement can be put aside.

Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research.

PURPOSE: The Adolescent Medicine Trials Network Protocol 113 (ATN113) is an open-label, multisite demonstration project and Phase II safety study of human immunodeficiency virus (HIV) preexposure prophylaxis with 15- to 17-year-old young men who have sex with men that requires adolescent consent for participation. The purpose of this study was to examine factors related to the process by which Institutional Review Boards (IRBs) and researchers made decisions regarding whether to approve and implement ATN113 so as to inform future biomedical HIV prevention research with high-risk adolescent populations. METHODS: Participants included 17 researchers at 13 sites in 12 states considering ATN113 implementation. Qualitative descriptive methods were used. Data sources included interviews and documents generated during the initiation process. RESULTS: A common process for initiating ATN113 emerged, and informants described how they identified and addressed practical, ethical, and legal challenges that arose. Informants described the process as responding to the protocol, preparing for IRB submission, abstaining from or proceeding with submission, responding to IRB concerns, and reacting to the outcomes. A complex array of factors impacting approval and implementation were identified, and ATN113 was ultimately implemented in seven of 13 sites. Informants also reflected on lessons learned that may help inform future biomedical HIV prevention research with high-risk adolescent populations. CONCLUSIONS: The results illustrate factors for consideration in determining whether to implement such trials, demonstrate that such protocols have the potential to be approved, and highlight a need for clearer standards regarding biomedical HIV prevention research with high-risk adolescent populations.

Physician Knowledge and Attitudes around Confidential Care for Minor Patients.

STUDY OBJECTIVE: Minor adolescent patients have a legal right to access certain medical services confidentially without parental consent or notification. We sought to assess physicians' knowledge of these laws, attitudes around the provision of confidential care to minors, and barriers to providing confidential care. DESIGN: An anonymous online survey was sent to physicians in the Departments of Family Medicine, Internal Medicine-Pediatrics, Obstetrics/Gynecology, and Pediatrics at the University of Michigan. RESULTS: Response rate was 40% (259/650). The majority of physicians felt comfortable addressing sexual health, mental health, and substance use with adolescent patients. On average, physicians answered just over half of the legal knowledge questions correctly (mean 56.6% ± 16.7%). The majority of physicians approved of laws allowing minors to consent for confidential care (90.8% ± 1.7% approval), while substantially fewer (45.1% ± 4.5%) approved of laws allowing parental notification of this care at the physician's discretion. Most physicians agreed that assured access to confidential care should be a right for adolescents. After taking the survey most physicians (76.6%) felt they needed additional training on confidentiality laws. The provision of confidential care to minors was perceived to be most inhibited by insurance issues, parental concerns/relationships with the family, and issues with the electronic medical record. CONCLUSIONS: Physicians are comfortable discussing sensitive issues with adolescents and generally approve of minor consent laws, but lack knowledge about what services a minor can access confidentially. Further research is needed to assess best methods to educate physicians about minors' legal rights to confidential healthcare services.

Minor consent and delivery of adolescent vaccines.

PURPOSE: To explore whether, and to what extent, minor consent influences adolescent vaccine delivery in the United States. METHODS: A telephone survey was completed by 263 professionals with responsibilities for adolescent health care and/or vaccination in 43 states. Measures included perceived frequency of unaccompanied minor visits and perceived likelihood of vaccine delivery to unaccompanied minors in hypothetical scenarios that varied by adolescent age, vaccine type, visit type, and clinical setting. RESULTS: Among the 76 respondents most familiar with private primary care clinics, 47.1% reported perceptions that 17-year-old patients often present without a parent/legal guardian. Among the 104 respondents most familiar with public primary care clinics, 56.7% reported that 17-year-old patients often present alone. In response to hypothetical scenarios, approximately 30% of respondents familiar with private clinics and 50% of respondents familiar with public clinics reported perceptions that unaccompanied 17-year-old adolescents would not receive influenza, Tdap, or human papillomavirus vaccines during routine check-ups because they could not provide consent. Perceived likelihood of unaccompanied minors receiving vaccines when seen for confidential services in primary care, sexually transmitted disease, and Title X/family planning clinics varied significantly by vaccine type and clinical setting. On average, respondents reported that they would support minors having the ability to self-consent for vaccines at age 14. CONCLUSIONS: The inability of minors to consent for vaccines is likely one barrier to vaccination. Interventions to increase adolescent vaccination should consider strategies that increase the ability of unaccompanied minors, particularly older minors, to receive vaccines within the context of legal, ethical, and professional guidelines.

Consentimento informado e competência em pediatria: opiniões de uma amostra de médicos romenos em treinamento / Informed consent and competence in pediatrics: opinions from a sample of Romanian physicians in training

OBJETIVOS: Analisar o ponto de vista de médicos em treinamento a respeito do consentimento informado como autorização autônoma em pediatria e discutir os efeitos limitantes da norma de competência nesse campo. MÉTODOS: Foi realizado um estudo multi-institucional com 158 residentes de medicina com o intuito de analisar o ponto de vista de médicos em treinamento a respeito do consentimento informado como autorização autônoma em pediatria. A participação no estudo foi voluntária, e os participantes eram provenientes de uma área geográfica limitada (Bucareste e arredores). RESULTADOS: A maioria dos respondentes concordou totalmente que um paciente entre 16 e 18 anos deve tomar decisões médicas informadas sobre qualquer tipo de procedimento (inclusive os referentes a escolhas reprodutivas); enquanto que pacientes entre 14 e 16 anos devem ser autorizados a tomar decisões médicas informadas apenas a respeito de procedimentos menores. A maioria concordou que transplantes de medula óssea devem ser permitidos entre irmãos se aprovados por ambos, enquanto que a maioria não concorda com o transplante de órgãos sólidos. A participação de crianças em estudos clínicos deve ser permitida apenas se a criança concordar. CONCLUSÕES: As respostas obtidas em nosso estudo sobre o consentimento informado aproximam-no mais do sentido de autorização autônoma do que do sentido de autorização efetiva. Portanto, a intuição moral dos participantes é mais bioética e menos jurídica, o que, embora maximize os benefícios do paciente, está associado a um aumento no risco de responsabilidade. No entanto, visto que as gerações mais novas tornam-se cada vez mais precoces, é preciso reavaliar os dogmas tradicionais a respeito da competência.

OBJECTIVES: To assess the views of physicians in training regarding the informed consent as autonomous authorization in pediatrics and to discuss the limiting effects of the competence norm in this field. METHODS: We conducted a multi-institutional survey with 158 medical residents in order to assess the views of physicians in training regarding the informed consent as autonomous authorization in pediatrics. The study was conducted with volunteer participants, from a limited geographical area (Bucharest and surrounding areas). RESULTS: Most respondents strongly agreed that a patient aged 16-18 years should make informed medical decisions regarding any type of procedures (including reproductive choices), whilst those aged 14-16 should be allowed to take informed medical decisions regarding minor procedures only. Most participants agreed that transplant procedures involving bone marrow should be allowed between siblings if they approve, whilst most disagreed allowing solid organ transplantation. The involvement of children in clinical studies should only be allowed if the children agree. CONCLUSIONS: The responses obtained in our study regarding the informed consent put it closer to the autonomic authorization sense than the effective authorization sense. Therefore, respondents' moral intuition is more bioethical and less legal, which, even if maximizing the patient's benefit, is associated with an increased liability risk. However, since the newer generations become more and more precocious, a reanalysis of the classical competence dogmas should be conducted.

Developmental Strategy for Stem Cell Therapy Products in Regulatory Considerations / 한양의대학술지

Expectation that stem cell therapy products will prove better and more effective in treating a variety of medical conditions continues to drive expanding research efforts. Stem cell therapy products consist of, or are derived from, populations of stem cell progenitors. They are complex and dynamic biological therapies which are highly regulated for safety and efficacy as biological products. The Korea Food Drug Administration (KFDA) is the legal authority responsible to regulate stem cell therapy products as stipulated by the Pharmaceutical Affairs Act. In this article, the regulatory review process used by the KFDA to assess the safety and effectiveness of novel stem-cell therapy products is described. The agency regularly updates and re-evaluates recommendations applicable to production and testing of stem cell therapy products based on the accumulation of scientific and clinical experiences.