Adolescent Self-Consent for COVID-19 Vaccination: Views of Healthcare Workers and Their Adolescent Children on Vaccination Autonomy
Original Article
Jeanne R. Delgado, Lisa N. Mansfield, Katia Bruxvoort, Mayra Macias, Joseph Grotts, Bruno Lewin, David Bronstein, Corrine Munoz-Plaza, Peter Szilagyi, John Chang, Kristen Choi
Journal of Adolescent Health, 10 February 2023
Abstract
Purpose
This study explored the perceptions of healthcare worker parents (physicians, nurses, and staff) and their adolescents (aged 12–17 years) on adolescent self-consent to COVID-19 vaccination by applying the concept of positive deviance of those already vaccinated against COVID-19.
Methods
We used a qualitative descriptive design to conduct individual, semi-structured interviews with COVID-19–vaccinated healthcare workers in Southern California and their vaccinated adolescent children. Separate interviews were conducted with parents and adolescents from November to December 2021 using digital phone conferencing software. All interviews were recorded and transcribed. Thematic and constant comparative analysis techniques were used to identify relevant themes and subthemes.
Results
Twenty one healthcare workers (9 nurses, one nurse practitioner, one technologist, and 10 physicians) and their adolescents (N = 17) participated. Three overarching themes were identified to describe participants’ perspectives about adolescent self-consent for COVID-19 vaccination: (1) Family values and practices around adolescent vaccination; (2) Differences in parent and adolescent support for vaccine self-consent laws; and (3) Parent and adolescent uncertainty on readiness for vaccine self-consent laws. Adolescents largely supported self-consent while parents supported the policy if they would be able to have a discussion with their adolescent prior to the decision.
Discussion
Parents and adolescents supported adolescent self-consent for COVID-19 vaccination, with the reservation that adolescents should discuss the decision alongside their parents to exercise their medical autonomy with supportive guidance. Greater adolescent involvement in making decisions and providing self-consent for healthcare, including vaccines, could prepare adolescents to have a greater sense of autonomy over their health and contribute to population health measures.
Month: March 2023
Consent Rights of Gender Diverse Children in Australia and the United Kingdom: Will the Court’s Involvement End?
Consent Rights of Gender Diverse Children in Australia and the United Kingdom: Will the Court’s Involvement End?
Jacko G
Journal of law and Medicine, 1 December 2022; 29(4) pp 1269-1287
Abstract
Gender diversity allows individuals to express their innate sense of self and has been increasingly recognised over time. Consequently, paediatric gender services have seen exponential increases in referrals internationally. This has resulted in novel issues for courts, such as a child’s “best interests” when accessing puberty-suppressing and gender-affirming medical care. Most recently, in the United Kingdom, the adequacy of information provided to transgender children and their families was also debated. Progression of the common law in Australia has resulted in transgender children consenting to medical treatment once Gillick competent. Yet, Bell v Tavistock [2020] EWHC 3274 temporarily halted the care of the United Kingdom’s transgender children, who were previously afforded consenting rights. On appeal it was determined to be inappropriate for the divisional court to have provided generalised guidance on children’s capacity to consent to medical therapy. Through comparative analysis of case law, the adequacy of these regulations will be assessed.
Children and bioethics: clarifying consent and assent in medical and research settings
Children and bioethics: clarifying consent and assent in medical and research settings
Invited Review
Merle Spriggs
British Medical Bulletin, 8 December 2022
Open Access
Abstract
Introduction
The concept of consent in the pediatric setting is complex and confusing. Clinicians and researchers want to know whose consent they should obtain, when a child can provide independent consent and how that is determined. The aim of this article is to establish what produces the justification to proceed with medical or research interventions involving children and the role of consent in that. I clarify concepts such as consent, assent, capacity and competence.
Source of data
Literature review.
Areas of agreement
Engaging with children and involving them in decisions about matters that affect them is a good thing. Areas of controversy: The role of competence or capacity and the question of when a child can provide sole consent.
Growing points
Flawed assumptions around competence/capacity.
Areas for developing research
An account of children’s well-being that accommodates children’s interests during the transition to adulthood.
Application of 3D printing technology for pre-operative evaluation, education and informed consent in pediatric retroperitoneal tumors
Application of 3D printing technology for pre-operative evaluation, education and informed consent in pediatric retroperitoneal tumors
Joong Kee Youn, Sang Joon Park, Young-Hun Choi, Ji-Won Han, Dayoung Ko, Jeik Byun, Hee-Beom Yang, Hyun-Young Kim
Scientific Reports, 30 January 2023
Open Access
Abstract
To investigate usefulness of 3D printing for preoperative evaluations, student and resident education, and communication with parents or guardians of patients with pediatric retroperitoneal tumors. Ten patients planning retroperitoneal tumor resection between March and November 2019 were included. Preoperative computed tomography (CT) images were used for 3D reconstruction and printing. Surveyed items were understanding of preoperative lesions with 3 different modules (CT, 3D reconstruction, and 3D printing) by students, residents, and specialists; satisfaction of specialists; and comprehension by guardians after preoperative explanations with each module. The median age at operation was 4.2 years (range, 1.8–18.1), and 8 patients were diagnosed with neuroblastoma. The 3D printing was the most understandable module for all groups (for students, residents, and specialists, P = 0.002, 0.027, 0.013, respectively). No significant intraoperative adverse events or immediate postoperative complications occurred. All specialists stated that 3D printing enhanced their understanding of cases. Guardians answered that 3D printing were the easiest to comprehend among the 3 modules (P = 0.007). Use of 3D printing in treatment of pediatric patients with retroperitoneal tumors was useful for preoperative planning, education, and parental explaining with obtaining informed consent.
Effects of a video-based positive side-effect information framing: An online experiment
Effects of a video-based positive side-effect information framing: An online experiment
Friederike L. Bender, Winfried Rief, Joscha Brück, Marcel Wilhelm
Health Psychology, 2023
Abstract
Objective
Despite the public health value of vaccines, vaccination uptake rates are stagnating. Expected adverse events following immunization are a major source of concern and play a role in the emergence of vaccine hesitancy. Since nocebo mechanisms are involved in the perception of adverse reactions, positive side-effect communication is warranted. The aim of the present study was to compile a comprehensive communication strategy that minimizes expectations of nocebo effects while respecting the informed consent procedure.
Method
In a randomized 2 × 2 between-subject design, 652 participants received information about COVID-19 or influenza vaccination using either standard side-effect messaging or messaging enriched with proven elements of expectation-optimizing framing. A physician presented information online via video. Moderation analyses were conducted to examine effects among particular subpopulations. Expected adverse event ratings following an imagined immunization, cost-benefit ratios of the vaccination, and future vaccination intentions were assessed.
Results
Information content ratings were equally high in each group. Positive framing significantly decreased adverse event expectations in the COVID-19 information group and raised the cost-benefit ratio in the influenza condition, indicating higher benefits than cost expectations. Moderation analysis revealed that the framed side-effect communication lowered the expected COVID-19 vaccination uptake willingness in individuals with strong anti-vaccination attitudes.
Conclusions
Facing the ongoing coronavirus mass vaccinations, positive information frames have a small but significant impact on vaccination concerns while upholding informed consent. Although intervention trials are still pending, this approach could help decrease vaccine hesitancy by reducing fearful expectations. However, it seems that it should not be used without considering vaccination attitudes.
Individualised consent for endoscopy: update on the 2016 BSG guidelines
Individualised consent for endoscopy: update on the 2016 BSG guidelines
Guideline
Nicholas Ewin Burr, Ian D Penman, Helen Griffiths, Andrew Axon, Simon M Everett
Frontline Gastroenterology, 7 February 2023
Abstract
In 2016, the British Society of Gastroenterology (BSG) published comprehensive guidelines for obtaining consent for endoscopic procedures. In November 2020, the General Medical Council (GMC) introduced updated guidelines on shared decision making and consent. These guidelines followed the Montgomery ruling in 2015, which changed the legal doctrine determining what information should be given to a patient before a medical intervention. The GMC guidance and Montgomery ruling expand on the role of shared decision making between the clinician and patient, explicitly highlighting the importance of understanding the values of the patient. In November 2021, the BSG President’s Bulletin highlighted the 2020 GMC guidance and the need to incorporate patient -related factors into decision making. Here, we make formal recommendations in support of this communication, and update the 2016 BSG endoscopy consent guidelines. The BSG guideline refers to the Montgomery legislation, but this document expands on the findings and gives proposals for how to incorporate it into the consent process. The document is to accompany, not replace the recent GMC and BSG guidelines. The recommendations are made in the understanding that there is not a single solution to the consent process, but that medical practitioners and services must work together to ensure that the principles and recommendations laid out below are deliverable at a local level. The 2020 GMC and 2016 BSG guidance had patient representatives involved throughout the process. Further patient involvement was not sought here as this update is to give practical advice on how to incorporate these guidelines into clinical practice and the consent process. This document should be read by endoscopists and referrers from primary and secondary care.
Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Informing a European guidance framework on electronic informed consent in clinical research: a qualitative study
Research
Evelien De Sutter, Pascal Borry, Isabelle Huys, Liese Barbier
BMC Health Services Research, 21 February 2023; 23(181)
Open Access
Abstract
Background
Electronic informed consent (eIC) may offer various advantages compared to paper-based informed consent. However, the regulatory and legal landscape related to eIC provides a diffuse image. By drawing from the perspectives of key stakeholders in the field, this study aims to inform the creation of a European guidance framework on eIC in clinical research.
Methods
Focus group discussions and semi-structured interviews were conducted with 20 participants from six stakeholder groups. The stakeholder groups included representatives of ethics committees, data infrastructure organizations, patient organizations, and the pharmaceutical industry as well as investigators and regulators. All were involved in or knowledgeable about clinical research and were active in one of the European Union Member States or at a pan-European or global level. The framework method was used for data analysis.
Results
Stakeholders underwrote the need for a multi-stakeholder guidance framework addressing practical elements related to eIC. According to the stakeholders, a European guidance framework should describe consistent requirements and procedures for implementing eIC on a pan-European level. Generally, stakeholders agreed with the definitions of eIC issued by the European Medicines Agency and the US Food and Drug Administration. Nevertheless, it was raised that, in a European guidance framework, it should be emphasized that eIC aims to support rather than replace the personal interaction between research participants and the research team. In addition, it was believed that a European guidance framework should include details on the legality of eIC across European Union Member States and the responsibilities of an ethics committee in the eIC assessment process. Although stakeholders supported the idea to include detailed information on the type of eIC-related materials to be submitted to an ethics committee, opinions varied on this regard.
Conclusion
The creation of a European guidance framework is a much needed factor to advance eIC implementation in clinical research. By collecting the views of multiple stakeholder groups, this study advances recommendations that may facilitate the development of such a framework. Particular consideration should go to harmonizing requirements and providing practical details related to eIC implementation on a European Union-wide level.
[Improper informed consent of the patient: legal and expert assessment]
[Improper informed consent of the patient: legal and expert assessment]
Kratenko MV
Sudebno-meditsinskaia Ekspertiza, 1 January 2023; 66(1) pp 59-62
Abstract
The purpose of the study is to draw the attention of the legal and medical community to the problem of insufficient awareness of the patient about the upcoming medical intervention; to identify the scope of interaction between the court and the expert in relation to disputes related to improper information. Despite the fact that the conclusion about improper informing of the patient implies a legal assessment of the circumstances, special medical knowledge is needed to identify some defects of voluntary informed consent. The expert, in particular, can answer the questions of the court about what risks are characteristic of a certain type of medical intervention (perforations, bleeding, etc.) and how high their probability was in relation to a particular patient (taking into account his state of health, anatomical features); whether there were alternative treatment options. Based on the explanations received, the court will be able to assess whether the patient’s attention was focused on the relevant circumstances, whether his consent was conscious, and the complications that occurred were foreseeable.
Editor’s note: This is a Russian language publication.
Principles of Informed Consent for Perinatal and Neonatal Nurses
Principles of Informed Consent for Perinatal and Neonatal Nurses
Rebecca L. Cypher
The Journal of Perinatal & Neonatal Nursing, January-March 2023; 37(1) pp 10-13
Excerpt
An informed consent process includes a patient’s ability to make a decision, a conversation explaining pertinent information to make a choice, and an agreement to receive a definitive type of care. Malpractice disputes are sometimes centered on whether a patient received adequate consent from a clinician prior to a treatment or procedure. In fact, The Joint Commission reported 49 informed consent–related sentinel events over an 11-year period. Consent arguments may arise in perinatal and neonatal allegations when an action results in an adverse event. As an illustration, a family claims that an infant’s death from a subgaleal hemorrhage was caused by an operative vaginal birth. These allegations stem from an accusation that informed consent incorporating maternal and newborn risks was not attained beforehand.
Obtaining informed consent goes beyond a signature on a form. Consent for care is vital for communication and shared decision-making between a clinician (eg, physician or advanced practice nurse) and a patient, a newborn’s parent, or a guardian. This process is designed to provide precise measures that allow patients to have an opportunity to ask questions and make an informed decision. From a liability perspective, when individuals fully comprehend risks and benefits of a treatment, they may cope better with a less than optimal outcome resulting from any care provided. In some circumstances, patients may be less likely to file a malpractice claim. This column offers a primer addressing certain doctrines of informed consent in a perinatal or neonatal setting…
Informed Consent in Dental Practice: A Qualitative Analysis of Awareness and Apprehensions Among Practitioners in South India
Informed Consent in Dental Practice: A Qualitative Analysis of Awareness and Apprehensions Among Practitioners in South India
Dr Baiju R M, Dr Elbe Peter, Dr Vivek Narayan, Dr Roshna E K, Dr Abhilash Babu, Dr Nandimath Omprakash V
International Journal of Social Science And Human Research, 2 February 2023; 6(2)
Open Access
Abstract
Context
The push for autonomy and liberalization has transformed the practice of medicine and dentistry from paternalism to a patient cantered model. Patient’s choice to accept or reject the proposed treatment is central to this new paradigm of health care. Informed consent is an essential tool for an ethical dental practice.
Aim
The objective of the present study was to explore the knowledge, attitudes, perceptions and prevailing practices among dentists regarding the informed consent process.
Materials and methods
A phenomenological approach was undertaken. A semi structured telephonic interview was conducted based on a flexible topic guide and continued until data saturation.
Statistical analysis
The data was transcribed verbatim. Coding and categorisation done. Anonymity was ensured in all steps. The data was subjected to a thematic analysis.
Results
Participants were apprehensive about the influence of social media on the new paradigm of doctor patient relationship and the increasing utility of specialists as a protection from litigation. Lack of clarity regarding the consent method has prevented its routine application.
Conclusions
It can be concluded that a comprehensive understanding regarding informed consent process was lacking among the participants.
Center for Informed Consent Integrity 