[Prescribing Contraceptives to Minors Without Parental Consent]

[Prescribing Contraceptives to Minors Without Parental Consent]
Goldstick O, Peled-Raz M
Harefuah, 1 November 2022, 161(11) pp 709-713
Abstract
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.

Editor’s note: This a hebrew language publication

Informed Consent and Public Health: The Case of Childhood Vaccination

Informed Consent and Public Health: The Case of Childhood Vaccination
Ivana Tucak, Gordana Pelčić
European Journal of Bioethics, 4 May 2022
Summary
Informed consent, which is primarily aimed at encouraging individual patients and subjects of scientific research to make autonomous decisions, and public health measures, such as compulsory vaccination against infectious diseases, the successfulness of which implies harmonized administration of vaccines to a broad population, seem to be irreconcilable opposites at first glance. This paper deals with investigating whether these opposites can reconcile or whether informed consent can be applied in the field of public health. The first part of the paper provides a short overview of the main features of informed consent and its relevance in treating individual patients. The second part of the paper tackles the issue of immunization. If not provided with consent of their patients or having a legal obligation, physicians are believed to interfere with the bodily integrity of other people when conducting vaccination and their act can be deemed as an assault and entail non-pecuniary damage compensation. Herd immunity as a “public good” can only be achieved if all people are equally subject to public health measures. At this point, the key question is if informed consent and appertaining freedom of decision-making represent a threat to the accomplishment of this public health goal. This question should truly be answered since vaccination may, though rarely, bring to medical complications, which may then lead to high treatment costs, loss of income and extremely rare, to death. The purpose of this paper is to demonstrate that disclosure of the risks and benefits of immunization within the framework of public health programmes could contribute to putting the fundamental bioethical postulates into practice: establishing and fostering mutual trust between physicians and their patients, which can, in the end, contribute to a higher immunization rate of a population.

Comparison of Spanish-Speaking Parental Understanding Using Two Alternative Consent Pathways

Comparison of Spanish-Speaking Parental Understanding Using Two Alternative Consent Pathways
Homa Amini, Andrew Carranco, Paul S. Casamassimo, Dennis McTigue, Jin Peng
Pediatric Dentistry, November-December 2022; 44(6) pp 400-403
Abstract
Purpose
The purpose of this study was to assess the understanding of Spanish-speaking caregivers consenting to dental core using general anesthesia (GA) utilizing two consent-delivery pathways.
Methods
Seventy-eight parents of children who never had GA were randomly assigned to one of two groups: (0) interpreter; or (2) video: they completed o survey to evaluate comfort level with GA and comprehension of areas of informed consent.
Results
Most parents in both groups understood the risks associated with GA (89 percent in the interpreter group and 90 percent in the video group). The majority of families had difficulty understanding indications for GA (64 percent in the interpreter group versus 60 percent in the video group). Overall, 97 percent of participants believed they sufficiently understood the information presented about GA. The mean score for comfort level with GA was 7.03 for the interpreter group and 6.82 for the video group.
Conclusion
Consent pathways used in this study were not significantly different for risk understanding and acquisition of consent-related knowledge.

Adolescent Capacity to Consent to Participate in Research: A Review and Analysis Informed by Law, Human Rights, Ethics, and Developmental Science

Adolescent Capacity to Consent to Participate in Research: A Review and Analysis Informed by Law, Human Rights, Ethics, and Developmental Science
Ben Mathews
Laws, 23 December 2022; 12(1)
Abstract
Contemporary societies pose major challenges for adolescents and it is essential to conduct research with them to understand their experiences, identify their needs, and discover solutions to major social problems. Social science, humanities and health-related research into violence, technology, and climate change exemplify vital research endeavours requiring adolescent participation to advance Sustainable Development Goals and enhance individual lived experience and societal flourishing for current and future generations. International and national research ethics guidelines emphasise the necessity to conduct research to advance societal benefit, while upholding principles of autonomy and justice, and promoting participant welfare and avoiding harm. International human rights instruments promote adolescents’ freedom of expression and right to participate in matters affecting them. The rapid generation of robust research findings is essential, but it remains commonly assumed that adolescents cannot provide their own consent to participate in research studies, and the belief that parental consent is required can impede and impair the entire research process. Debate continues about the proper interpretation of legal principles and research ethics guidelines about who may provide consent. Continuing confusion about who must provide consent, and why, impedes the protection of adolescents’ interests and the advancement of society. This article adds to knowledge by providing a multidisciplinary overview of evidence from developmental science, social science, law, human rights, and bioethics about decision-making capacity and entitlements in the context of research participation, and an updated evidence-based analysis of adolescents’ capacity to provide their own consent to participate in social, humanities and health-related research. A conservative application of knowledge from these domains both individually and collectively supports conclusions that adolescents aged 16 are able to provide their own consent to participate in research, and no legal or ethical principle requires the provision of parental consent on their behalf. Practical considerations may support parental involvement in conversations about participation, and some types of research require trauma-informed approaches, but adolescents are developmentally, legally and ethically entitled to make their own decision about whether or not to participate.

Disability or Death: A Focused Review of Informed Consent in Pediatric Neurosurgery

Disability or Death: A Focused Review of Informed Consent in Pediatric Neurosurgery
Nathan A. Shlobin, John Paul G. Kolcun, Brian D. Leland, Laurie L. Ackerman, Sandi K. Lam, Jeffrey S. Raskin
Seminars in Pediatric Neurology, 22 December 2022
Abstract
The management of pediatric neurosurgical disease often requires families to choose between long-term disability and premature death. This decision-making is codified by informed consent. In practice, decision-making is heavily weighted toward intervening to prevent death, often with less consideration of the realities of long-term disability. We analyze long-term disability in pediatric neurosurgical disease from the perspectives of patients, families, and society. We then present a pragmatic framework and conversational approach for addressing informed consent discussions when the outcome is expected to be death or disability. We performed a focused review of literature regarding informed consent in pediatric neurosurgery by searching PubMed and Google Scholar with search terms including “pediatric neurosurgery,” “informed consent,” and “disability.” The literature was focused on patients with diagnoses including spina bifida, neuro-oncology, trauma, and hydrocephalus. Patient perspective elements were physical/mental disability, lack of autonomy, and role in community/society. The family perspective involves caregiver burden, emotional toll, and financial impact. Societal considerations include the availability of public resources for disabled children, large-scale financial cost, and impacts on global health. Practical conversational steps with patients/caregivers include opening the discussion, information provision and acknowledgement of uncertainty, assessment of understanding and clarifying questions, decision-making, and decision maintenance, all while remaining sensitive to the emotional burden commensurate with these decisions. The “death or disability” paradigm represents a common challenge to informed consent in pediatric neurosurgery. Patient, family, and societal factors that inform surrogate decisions vary and sometimes conflict. Pediatric neurosurgeons must use a comprehensive approach to address the informational and relational needs of caregivers during the informed consent process.

Paediatric surgeons’ current knowledge and practices of obtaining assent from adolescents for elective reconstructive procedures

Paediatric surgeons’ current knowledge and practices of obtaining assent from adolescents for elective reconstructive procedures
Original Research
Krista Lai, Nathan S Rubalcava, Erica M Weidler, Kathleen van Leeuwen
JME, 21 December 2022
Abstract
Purpose
Adolescents develop their decision-making ability as they transition from childhood to adulthood. Participation in their medical care should be encouraged through obtaining assent, as recommended by the American Academy of Pediatrics (AAP). In this research, we aim to define the current knowledge of AAP recommendations and surgeon practices regarding assent for elective reconstructive procedures.
Methods
An anonymous electronic survey was distributed to North American paediatric surgeons and fellows through the American Pediatric Surgical Association (n=1353).
Results
In total, 220 surgeons and trainees responded (16.3%). Fifty per cent of the surgeons who are familiar with the concept of assent had received formal training; 12% of the respondents had not heard of assent before the survey. Forty-seven per cent were aware of the 2016 AAP policy statement regarding assent in paediatric patients. Eighty-nine per cent always include adolescents as part of the consent discussion. Seventy-seven per cent solicit an expression of willingness to accept the proposed care from the patient. The majority (74%) of the surgeons perceived patient cooperation/understanding as the biggest barrier to obtaining assent. Over half of the respondents would consider proceeding with elective surgery despite the adolescent patient’s refusal. Reasons cited for proceeding with elective surgery include surgeons’ perception of medical necessity, perceptions of disease urgency, and lack of patient maturity.
Conclusion
Paediatric surgeons largely acknowledge the importance of assent, but variably practice the principles of obtaining assent from adolescent patients undergoing elective reconstructive procedures. Fewer surgeons are explicitly aware of formal policy statements or received formal training. Additional surgeon education and institutional policies are warranted to maximise inclusion of adolescents in their medical care.

Adolescent Confidentiality and Consent in an Emergency Setting

Adolescent Confidentiality and Consent in an Emergency Setting
Mientkiewicz L, Grover P
Pediatric Emergency Care, 1 December 2022; 38(12) pp 697-699
Abstract
Objectives
The adolescent population comprises a large volume of emergency department visits each year. A recent study showed that 20% of the ambulatory care visits of adolescent patients aged 15 to 25 years were made to the emergency department. This specific population often has poor access to health care and often is a vulnerable population, causing medical care to be a challenge. The purpose of this article was to review the standard practice and the specific laws regarding confidentiality and consent when treating an adolescent patient to provide the best possible care and treatment.
Methods
A comprehensive literature search was done to examine key aspects of adolescent confidentiality and informed consent in an emergency setting. The literature was then compiled into a review article.
Results
The article outlines the specific laws for emergency providers to be aware of regarding patient confidentiality and consent. The adolescent patient can consent to medical care without parental consent, when involving emergency care, contraceptive services, sexually transmitted infections, prenatal care, drug or alcohol related care, mental health services, and sexual assault services. Also, emancipated minors and mature minors are both situations in which a minor has the legal authority to refuse care and make decisions regarding their health care.
Conclusions
Patient confidentiality and informed consent are complex and complicated topics when dealing with the pediatric patient. Although some laws may vary state to state, there are specific details regarding adolescent confidentiality and informed consent that every provider should be aware of. The adolescent population is more likely to seek emergency care if the visit is confidential and the patient feels a sense of trust. Although it is important for providers to respect patient confidentiality when treating adolescents, it is also important for providers to encourage adolescents to confide in their parents regarding health issues.

Assent in Pediatric Critical Care Research: A Cross-Sectional Stakeholder Survey of Canadian Research Ethics Boards, Research Coordinators, Pediatric Critical Care Researchers, and Nurses

Assent in Pediatric Critical Care Research: A Cross-Sectional Stakeholder Survey of Canadian Research Ethics Boards, Research Coordinators, Pediatric Critical Care Researchers, and Nurses
Katie O’Hearn, Florence Cayouette, Saoirse Cameron, Dori-Ann Martin, Anne Tsampalieros, Kusum Menon
Pediatric Critical Care Medicine, 13 October 2022
Abstract
Objectives
Survey of four stakeholder groups involved in defining and obtaining assent for research in Canadian PICUs to better understand their perspectives and perceived barriers to assent.
Design
Cross-sectional survey.
Setting
Fourteen tertiary-care pediatric hospitals in Canada.
Participants
Research Ethics Board Chairs, pediatric critical care nurses, research coordinators, and researchers.
Interventions
None.
Measurements and Main Results
A total of 193 participants responded. Thirty-seven percent (59/159) thought it was “Never/Almost Never” (59/159, 37%) feasible to obtain assent during the first 48 hours of PICU admission, and 112 of 170 (66%) indicated there are unique barriers to assent at the time of enrollment in PICU studies. Asking children for assent was most frequently rated as Important/Very Important for interviews/focus groups with the child (138/180, 77%), blood sample collection with a needle poke for research (137/178, 77%), and studies involving genetic testing with results communicated to the child/legal guardian (134/180, 74%). In two scenarios where a child and legal guardian disagreed about study participation, most respondents indicated that whether the child should still be enrolled would depend on the patient’s age (34-36%), and/or the risk of the study (24-28%). There was a lack of consensus over how the assent process should be operationalized, and when and for how long children should be followed to seek assent for ongoing study participation. Most stakeholders (117/158, 74%) thought that children should have the opportunity to decide if their samples could stay in a biobank once they are old enough to do so.
Conclusions
There was an overall lack of consensus on the feasibility of, and challenges associated with, obtaining assent at the time of study enrollment and on how key aspects of the assent process should be operationalized in the PICU. This highlights the need for guidelines to clarify the assent process in pediatric critical care research.

A Bioethics Framework for At-risk Child/Adolescent Access to Key Reproductive Health Services Without Parental Consent

A Bioethics Framework for At-risk Child/Adolescent Access to Key Reproductive Health Services Without Parental Consent
Forouzan Akrami, Alireza Zali, Mahmoud Abbasi
Iranian Journal of Pediatrics, December 2022; 32(6)
Open Access
Abstract
Context
Access of adolescents to key reproductive health services (KRHS) has been emphasized; however, how to provide it has not been addressed. This study aimed to propose a bioethics framework to justify at-risk child/adolescent access to KRHS without parental consent.
Evidence Acquisition
First, articles and documents were searched using the age of consent laws, reproductive health, and ethical/legal standards phrases with AND/OR separators in PubMed and Web of Science using the Google Scholar search engine in English. After a concise review of the age of consent in child/adolescent-related laws, at-risk child/adolescent access to KRHS without parental consent was justified using major ethical and legal principles and standards.
Results
Given the different purposes and nature of harm preventive services, in the first part, the authors argue that considering the age of consent for at-risk adolescents’ access to KRHS is a limiting and inefficient factor, and KRHS could be provided for the at-risk adolescent with his/her own assent. In the second part, the authors argue that in decision-making for at-risk adolescents’ access to KRHS, the best interest standard is applicable on the ground of harm standard. Regarding the sociocultural context of the community, after assessing the seriousness of the harm and the threshold of intervention, practical steps are taken toward reducing or removing harm and choosing the option that best promotes adolescents’ interests.
Conclusions
Regarding the existence of restrictive laws, the suggested framework can be applied in different communities as a bioethics policy guide for legislation and appropriate actions of adolescents’ healthcare professionals.

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials

What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials
Research article
Nut Koonrungsesomboon, Pimlak Charoenkwan, Rungrote Natesirinilkul, Kanda Fanhchaksai, Wannachai Sakuludomkan, Nimit Morakote
BMC Medical Ethics, 16 November 2022; 23(113)
Open Access
Abstract
Background
This study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form (IAF)/informed consent form (ICF) of a pediatric drug trial.
Methods
A descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each item in a questionnaire, by giving a rating scale from 1 (not important) to 5 (very important).
Results
A total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects (i.e., direct health benefit [mean: 4.71 for child respondents, 4.89 for parent respondents], indirect/societal benefit [mean: 4.65, 4.85], major foreseeable risk [mean: 4.47, 4.78], post-trial benefit/provision [mean: 4.59, 4.74], and all adverse effects of the drug including uncommon adverse effects [mean: 4.53, 4.74]) were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.
Conclusions
For pediatric drug trials, risk–benefit information (including direct health benefit, indirect/societal benefit, and post-trial benefit/provision, as well as major foreseeable risk and adverse effects of the drug) should be made a salient feature of an IAF/ICF. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/ICF to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases.