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3.
BMC Med Ethics ; 23(1): 130, 2022 12 08.
Artigo em Inglês | MEDLINE | ID: mdl-36482457

RESUMO

The enrolment of children and adolescents in health research requires that attention to be paid to specific assent and consent requirements such as the age range for seeking assent; conditions for parental consent (and waivers); the age group required to provide written assent; content of assent forms; if separate assent and parental consent forms should be used, consent from emancipated young adults; reconsent at the age of adulthood when a waiver of assent requirements may be appropriate and the conditions for waiving assent requirements. There is however very little available information for researchers and ethics committees on how to navigate these different issues. To provide guidance to research initiatives, the SickleInAfrica consortium conducted a thematic analysis of a sample of research ethics guidelines and procedures in African countries, to identify guidance for assent requirements in health research. The thematic analysis revealed that 12 of 24 African countries specified the age group for which assent is required. The minimum age for written assent varied across the countries. Five countries, Algeria, Botswana, Cameroon, Nigeria and The Democratic Republic of Congo require consent from both parents/family council in certain circumstances. Botswana, Nigeria, South Africa and Uganda have specific assent/consent requirements for research with emancipated minors. South Africa and Algeria requires re-consent at onset of adulthood. Five countries (Botswana, Cameroon, Nigeria, South Africa and Tanzania) specified conditions for waiving assent requirements. The CIOMS and the ICH-GCP guidelines had the most comprehensive information on assent requirements compared to other international guidelines. An interactive map with assent requirements for different African countries is provided. The results show a major gap in national regulations for the inclusion of minors in health research. The SickleInAfrica experience in setting up a multi-country SCD registry in Africa highlights the need for developing and harmonising national and international guidelines on assent and consent requirements for research involving minors. Harmonisation of assent requirements will help facilitate collaborative research across countries.


Assuntos
Consentimento dos Pais , Criança , Humanos , Adolescente , Adulto , Botsuana , Nigéria , África do Sul , Camarões
5.
Harefuah ; 161(11): 709-713, 2022 Nov.
Artigo em Hebraico | MEDLINE | ID: mdl-36578244

RESUMO

INTRODUCTION: The Israeli Legal Capacity and Guardianship Law, denies minors the right to decide upon medical treatment, and regards medical treatment of minors, including contraception, without parental consent as an infringement of parental autonomy. Yet, adolescent girls occasionally ask doctors to prescribe them contraceptives, while refusing parental involvement. This article reviews the relevant legal situation, examines some comparative legal stances and refers to the ethical aspects that should be considered during contraceptive advice to minors, in light of the United Nations Convention on the Rights of the Child. Seeking contraception is an example of mature behaviour, and when a minor asks for contraception, the physician has to act in her best interests. In the decision to prescribe contraceptives without parental consent or even knowledge, doctors should consider the girl's ability to understand their advice, the risks associated with lack of parental involvement, the significance of parental autonomy infringement, the risks to the girl if the parents will be informed contrary to her request, and the girl's risks of unintended pregnancy, associated with not using contraception. In this article we suggest means and modes of action in a situation when an adolescent needs contraception and denies any parental involvement.


Assuntos
Consentimento dos Pais , Médicos , Adolescente , Gravidez , Criança , Feminino , Humanos , Anticoncepcionais , Consentimento Livre e Esclarecido , Anticoncepção , Pais
6.
Pediatrics ; 150(6)2022 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-36443237

RESUMO

The clinical utility of rapid genome sequencing (rGS) in critically unwell infants has been consistently demonstrated, and there are calls for rGS to be implemented as a first-line test in the NICU. A diagnosis from rGS can enable rapid initiation of precision treatment, making it potentially lifesaving. However, in many patients rGS leads to the diagnosis of severe and life-limiting conditions, prompting discussion with families about withdrawal of life-sustaining treatment. The complexity of information about rGS, together with the heightened emotions of parents in the NICU, poses significant challenges for informed decision making in this context. We present a case where both parents are unable to provide informed consent, and the treating team must decide whether to proceed with rGS. Our discussion highlights the important differences between genome sequencing and other types of genetic testing, and the crucial role played by pre-test counseling in facilitating informed consent and preparing parents for a range of possible outcomes. We then discuss the consent paradigms at play in NICUs; whereas admission generally comes with an understanding that the treating team will perform interventions thought to be in the best interest of the child, rGS is substantially different because of its long-term implications for patients and family members. Finally, we look at the ethical interplay between parental consent and the interests of the child. We conclude by showing how cases like this are resolved at our tertiary center and how they may be resolved differently in future.


Assuntos
Unidades de Terapia Intensiva Neonatal , Terapia Intensiva Neonatal , Criança , Lactente , Recém-Nascido , Humanos , Consentimento dos Pais , Pais , Família
7.
BMC Med Ethics ; 23(1): 98, 2022 09 24.
Artigo em Inglês | MEDLINE | ID: mdl-36153500

RESUMO

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.


Assuntos
Tutores Legais , Consentimento dos Pais , Adolescente , Criança , Humanos , Consentimento Livre e Esclarecido , Princípios Morais , Pais , África do Sul
8.
Arch Pediatr ; 29(8): 541-547, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36104268

RESUMO

The provision of medical care for minors can be complicated. On the one hand, the pattern of the traditional family has changed and many parents are separated while retaining parental authority, which can make the pursuit of parental consent even more complex. In addition, French law, in line with international law, has modified the place of minors in the healthcare relationship, acknowledging the importance of seeking their consent. Such consent is sometimes even required for certain medical procedures. This consent from minors may even allow care to be provided to them without the consent of their parents.


Assuntos
Consentimento dos Pais , Pais , Humanos , Menores de Idade , Consentimento Livre e Esclarecido , Confidencialidade
11.
Pediatrics ; 150(3)2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-35739620

RESUMO

The American Academy of Pediatrics reaffirms its position that the rights of adolescents under 18 years of age to confidential care when considering legal medical and surgical abortion therapies should be protected. Most adolescents voluntarily involve parents and other trusted adults in decisions regarding pregnancy termination and should be encouraged to do so when safe and appropriate. The legal climate surrounding abortion law is rapidly becoming more restrictive and threatens to adversely impact adolescents. Mandatory parental involvement, the judicial bypass procedure, and general restrictive abortion policies pose risks to adolescents' health by causing delays in accessing medical care, increasing volatility within a family, and limiting their pregnancy options. These harms underscore the importance of adolescents' access to confidential abortion care. This statement presents a summary of pertinent current information related to the impact of legislation requiring mandatory parental involvement in an adolescent's decision to obtain abortion services.


Assuntos
Aborto Induzido , Consentimento dos Pais , Aborto Legal , Adolescente , Adulto , Criança , Feminino , Humanos , Função Jurisdicional , Relações Pais-Filho , Gravidez , Estados Unidos
13.
Neonatology ; 119(2): 214-221, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35184062

RESUMO

BACKGROUND: Obtaining ethically valid consent to participate in delivery room (DR) studies from parents facing an imminent premature birth can be challenging. This study aims to provide insight into parental experiences with and perceptions of consent for DR studies. METHODS: Semistructured interviews were conducted with parents of very and extreme preterm infants. Interviews were audio-recorded, transcribed, and analyzed using the qualitative data analysis software Atlas. ti V.8.4. RESULTS: Twenty-five parents were interviewed. Despite being in an emotional and stressful situation, most parents considered being approached for DR studies as valuable. According to parents, this was mostly due to appropriate timing and communication, compassion, and investigators not being obtrusive. Interviewed parents generally decided to accept or decline study participation based on perceived risk. Parents differed widely in how risk of specific study interventions was perceived, but agreed on the fact that parental consent is needed for DR studies that involve risk. There was no consensus among parents on deferred consent for DR studies running at our NICU. However, parents considered deferred consent appropriate for observational studies. Furthermore, it became clear that parental misunderstanding of various aspects of DR studies, including aims, the concept of randomization, and risk associated with specific interventions, was common. CONCLUSIONS: Insight into parental perceptions of consent for DR studies allowed us to determine areas where the validity of parental consent can be improved. Further research on parental perspectives for consent for DR studies will allow us to establish consent procedures that are considered both valid and valuable.


Assuntos
Salas de Parto , Doenças do Recém-Nascido , Feminino , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Consentimento dos Pais , Pais/psicologia , Gravidez
14.
Br Dent J ; 232(2): 115-119, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-35091615

RESUMO

Introduction Informed consent is the 'permission or agreement' given by the patient for a proposed action. This paper explores the clinician's role in obtaining informed consent, provides an overview of consent and parental responsibility in the UK, and presents practical adjuncts to aid dental professionals in ascertaining who has parental responsibility to delineate persons capable of providing assent on behalf of an underage patient.Consent and parental responsibility While the principles of consent have largely stayed constant with time, subtleties in parental responsibility legislation exist in different regions of the UK. An audit exploring consent and parental responsibility knowledge among clinicians within the orthodontic department at the UCLH Eastman Dental Hospital demonstrated that none of the respondents met the gold standard (100%). The results ranged from 59-89% with a mean score of 74%. The majority of questions answered incorrectly related to knowledge of parental responsibility.Conclusion It is the responsibility of clinicians providing any care within the UK to stay up to date with legislation and regulations regarding consent and parental responsibility. Knowledge-based questionnaires can highlight areas of knowledge deficit which can be addressed through continuous professional development. This paper provides a flowchart summarising parental responsibility and a prefilled parental responsibility questionnaire as adjuncts to simplify the process of dental professionals ascertaining parental responsibility.


Assuntos
Consentimento Livre e Esclarecido , Pais , Humanos , Consentimento dos Pais , Inquéritos e Questionários
15.
J Med Ethics ; 48(2): 106-111, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-32366701

RESUMO

There have been calls for mandatory vaccination legislation to be introduced into the UK in order to tackle the national and international rise of vaccine-preventable disease. While some countries have had some success associated with mandatory vaccination programmes, the Royal College of Paediatrics and Child Health (RCPCH) insist this is not a suitable option for the UK, a country which has seen historical opposition to vaccine mandates. There is a lack of comprehensive data to demonstrate a direct link between mandatory vaccination legislation and increased uptake. While there are examples whereby there has been an improvement, some studies suggest that comparable results can be obtained by strongly recommending vaccinations instead. The RCPCH insist that healthcare workers are ideally placed to engage and inform parents to make every interaction a 'vaccine opportunity'. This paper calls for a principled, rational approach to interpretations of autonomy which underpin parental informed consent. MacLean's concept of mutual persuasion could be a vehicle to ensuring parents are suitably informed of both the material risks associated with vaccine choices and to consider the rationality of their decisions, while ultimately upholding parental autonomy. It is argued that this, alongside infrastructural improvement, could create a more sustainable, long-term improvement in childhood vaccination rates in the UK than mandatory vaccination.


Assuntos
Comunicação Persuasiva , Vacinas , Criança , Humanos , Consentimento Livre e Esclarecido , Consentimento dos Pais , Pais , Vacinação
17.
Dev World Bioeth ; 22(3): 140-151, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-33605030

RESUMO

Pediatric cancer is accompanied by many ethical challenges, particularly those related to respecting the child's opinion and parental responsibility and consent. Questionnaires were collected from 400 participants, from four equal groups: doctors, nurses, parents and medical students, from three cities in Saudi Arabia, about three problematic issues which revolve around the mandatory consent of one or both parents, the extent of a child's assent, and the acceptable form of consent and assent. Despite the diversity of the participants' cultural backgrounds, most preferred both parents to give consent, followed by either parent without differentiation between parents, which reinforced a trend towards more gender equality. The majority of participants preferred that parental consent forms be detailed enough to obtain the maximum information, while others chose medium-size consent forms; a large majority preferred that the form seeking to obtain the assent of the child with cancer be short, reflecting their desire not to increase the burden on the child, in addition to the fact that the final decision belongs to the parents rather than the child. Most participants preferred to rely on a child's level of maturity rather than having reached a certain age so that they could give assent, while the rest considered the age of 13-14 as a suitable age. These findings reflect an increasing ethical awareness regarding parental consent and child assent, and they can be formulated in a recommendation for a more ethical practice in the field of childhood cancer and pediatrics in general.


Assuntos
Consentimento Livre e Esclarecido , Neoplasias , Criança , Tomada de Decisões , Humanos , Consentimento dos Pais , Pais , Arábia Saudita , Inquéritos e Questionários
18.
Pediatr Res ; 91(5): 1156-1162, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34088985

RESUMO

BACKGROUND: Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies. METHODS: This was a cross-sectional survey assessing parents' willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision. RESULTS: Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited "benefits that research would provide to future children" most strongly influenced their decision to agree. CONCLUSIONS: ED investigators should highlight the benefits for future children and inquire about parents' previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated. IMPACT: Obtaining consent for pediatric emergency research is challenging and this study identified factors influencing parental consent for research in EDs. Benefits for future children and parents' previous research experience were two of the most influential factors in parents' willingness to consent to ED research studies. These findings will help to improve enrollment in ED research studies and better our understanding of how to promote the health and well-being of pediatric patients.


Assuntos
Serviço Hospitalar de Emergência , Consentimento dos Pais , Criança , Estudos Transversais , Humanos , Pesquisa
19.
J Med Ethics ; 48(11): 857-860, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34261805

RESUMO

Decreasing unintended teenage pregnancy, especially repeat teenage pregnancy, is an important public health goal. Unfortunately, legal barriers in the USA impede this goal as all minors are unable to consent for birth control in 24 states, and only 10 of those states allow consent after the minor has given birth according to state statutory law. Placement of long-acting reversible contraception (LARC) is one of the most effective methods of preventing rapid repeat pregnancies. However, restrictions are placed on adolescents who may not have the option of parental consent if the parents are unwilling, or not present, to give consent. A predicament arises when healthcare professionals are willing to place the contraceptive for the patient, but cannot due to the restrictions and guidelines outlined by each state. Even though these adolescents are legally viewed as minors, adolescent mothers should be able to consent to the placement of LARC. Notably, adolescents have the legal ability to give consent for the healthcare of their child starting in the prenatal period. I argue that this ability should be extended to include adolescent consent for their own healthcare. Additionally, the procedure to place LARC is relatively low risk and highly effective, which is an opportune situation to allow minors to consent. Allowing adolescents to consent to LARC after delivery is a simple and effective way to decrease rapid repeat pregnancy rates in the USA.


Assuntos
Contracepção Reversível de Longo Prazo , Gravidez na Adolescência , Adolescente , Criança , Gravidez , Feminino , Humanos , Consentimento dos Pais , Anticoncepção/métodos , Aborto Legal , Gravidez na Adolescência/prevenção & controle , Menores de Idade
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