Implementing new consent procedures for schools-based human papillomavirus vaccination: a qualitative study
Research
Suzanne Audrey, Karen Evans, Michelle Farr, Joanne Ferrie, Julie Yates, Marion Roderick, Harriet Fisher
British Journal of Child Health, 10 April 2021; 2(2)
Abstract
Background
The requirement for written parental consent for school-based human papillomavirus vaccination programme in England can act as a barrier to uptake for some young women, with the potential to exacerbate health inequities.
Aims
To consider the practicalities and implications of implementing new consent procedures, including parental telephone consent and adolescent self-consent, in two local authority areas in the southwest of England.
Methods
Digitally recorded, semi-structured interviews were conducted with 53 participants, including immunisation nurses, school staff, young people, and parents. All interviews were fully transcribed and thematic analysis was undertaken.
Results
Parental telephone consent was welcomed by the immunisation nurses, parents, and young women in the study. Adolescent self-consent was rare. Greater understanding of the barriers to uptake outside of mainstream school-based sessions is needed to further address inequalities in uptake.
Conclusions
The new procedures generally worked well but some important barriers to vaccination uptake remain.

Primary caregivers’ experience with the informed consent process in the paediatric emergency department: An interview-based qualitative study
Adonis Wazir, Ibrahim Sandokji, Morten Greaves, Rasha D Sawaya
Paediatrics & Child Health, 3 April 2021
Abstract
Objective
This study aims to understand primary caregivers’ (PCG) experience with the informed consent (IC) process.
Methods
We conducted in-depth interviews with PCGs of paediatric patients who underwent a procedure requiring IC in the paediatric emergency department (PED) of a tertiary care paediatric centre in the USA, between January and March 2013 and between September 2013 and January 2014. We triangulated the qualitative findings from the PCG interviews with Likert-scale responses from the PCGs and with results from surveyed physicians.
Results
We included 14 PCG–physician dyads. Our results show that PCGs understand the importance of the IC process. They appreciated the calm demeanor of providers, and the clarity of their wording. PCGs felt that IC can add to the stress, and that it could be made simpler and timelier. PCGs also had varying extents of retention of the information provided.
Conclusion
This exploratory study suggests an overall positive IC experience of the PCGs while highlighting areas for improvement including a more thorough discussion of alternatives, a better assessment of knowledge transmission and retention by the PCG, and recognition of the PCG’s discomfort during decision making in a stressful environment.

Forms to capture child consent to surgical procedures: Time to focus on function rather than form
A Strode, C Badul
South African Journal of Bioethics and Law, April 2021; 14(1)
Open Access
Abstract
It is uncontroversial that no form of treatment, including a surgical operation, can be undertaken without the consent of the patient/proxy. The Children’s Act deals expressly with consent to ‘surgical operations’ on children. Section 12 creates a framework based on the principles of child participation and protection. Nevertheless, obtaining consent from children remains complex: firstly, children are legal minors and have limited capacity to act independently. Secondly, there may be risks or longer-term consequences of surgery that distinguish it from medical treatment. Third, a child’s capacity to understand risks is not static: it evolves with age, and limited tools exist to access capacity. Fourth, there are at least three parties to the consent procedure – the child, the parent/guardian and the medical practitioner, all of whom may have different interests. Fifth, in some instances there is the added complication of child parents who need to provide consent for their own child. This article aims to provide guidance to surgeons and other medical practitioners performing surgery on children. It does this through setting out the legal norms relating to child consent to an operation. It critically examines the pro forma consent forms (forms 34 and 35) found in the regulations issued in terms of the Children’s Act that are to be used to document the consent process, and identifies key gaps and weaknesses. It concludes with recommendations for the adaptation of these forms through the use of a checklist to ensure that all the requirements for valid consent are documented, protecting children and medical practitioners.

‘Informed consent’ in consensual child welfare: some reflections on its controversial nature
Rosi Enroos, Johanna Korpinen, Tarja Pösö
European Journal of Social Work, 28 March 2021
Open Access
Abstract
The article examines the nature of consent in the context of Finnish care order decision-making as described by social workers, parents and young people, all personally involved in care order decision-making, albeit in different roles: on the one hand, an authority asking for the view about a child removal, and on the other, a party expressing a view which has huge legal, social and moral implications for their family relations. Based on qualitative data, the analysis examines two criteria for informed consent: adequate information and freedom from undue influence. The findings highlight the messy and blurred nature of consent that is found in other fields of practice as well. There are, however, some distinctive features relevant to consensual services in child welfare which need to be further elaborated. In particular, family relationality shapes the nature of consent through intra-familial power and emotions, differently for parents and children. Critical awareness of the nature of consent is also important for an understanding of service-user participation and self-determination.

Informed Consent From Children
Tim Moore
Sage Research Methods, 17 September 2019
Abstract
Children’s informed consent in participatory research is an essential component to ethical research practice. Although there has been significant attention from researchers about the importance of seeking children’s informed consent prior to their participation in data collection, some commentators see consent as an ongoing process rather than a hurdle to be overcome prior to data collection. After discussing the participation of children in research, this entry presents five steps that may help researchers consider how to embed informed consent in research activities as well as examples to show how researchers can assist children to understand, indicate, utilize, and reflect on their consent.

Minors’ consent: a case study on organ donation from living minors
Gunpirom Wisadsing
Public Health Policy & Laws Journal, January – April 2021; 7(1)
Open Access
Abstract
The primary objective of this article is to study the criteria for organ donation consent from living minors, which includes the conditions and methods of minors’ consent, the roles of parents’ consent with minors, and the responsibility of relevant organizations to consider minors’ consent for organ transplant donation. This article covers the comparative study of foreign laws in order to reflect an appropriate application of the laws to the Thai context.

Parental decision making regarding consent to randomization on Children’s Oncology Group AALL0932
Kellee Parker, Erika Cottrell, Linda Stork, Susan Lindemulder
Pediatric Blood & Cancer, 26 January 2021
Abstract
Background
Within pediatric oncology, parental decision making regarding participation in clinical trials that aim to reduce therapy to mitigate side effects is not well studied. The recently completed Children’s Oncology Group trial for standard‐risk acute lymphoblastic leukemia (AALL0932) included a reduction in maintenance therapy, and required consent for randomization immediately prior to starting maintenance. At our institution, 40% of children enrolled on AALL0932 were withdrawn from protocol therapy prior to randomization due to parental choice. This study sought to identify factors that impacted parental decision making regarding randomization on AALL0932.
Procedure
Parents of children enrolled on AALL0932 at our institution were eligible if their child met criteria for the average‐risk randomization. Parents were invited to participate in a 30‐50‐minute phone interview. Questions focused on factors that shaped parental decision making about randomization, as well as their perspectives about the clinical trial experience more generally.
Results
Fear of receiving less therapy and subsequent relapse was the predominant reason to decline randomization. Reasons given for consenting to randomization included trust in the physician, altruism, hope for less therapy, and potential for fewer side effects. Parents also reflected on ways to support future families making decisions about clinical trial participation.
Conclusion
While many parents recognize the importance of clinical trials aiming to mitigate side effects, the fear of their own child relapsing with less than standard therapy may dissuade them from study participation. Recognizing and addressing these concerns will be important for enrollment and retention in future clinical trials.

Adolescent Consent for HPV Vaccine: Ethical, Legal, and Practical Considerations
Gregory D. Zimet, Ross D. Silverman, Robert A. Bednarczyk, Abigail English
The Journal of Pediatrics, 20 January 2021
Abstract
Healthy People 2020 set a goal of 80% series completion for HPV vaccine.  The 2019 National Immunization Survey-Teen shows that 54.2% of adolescents aged 13-17 years were up-to-date with the vaccine series. Although this coverage level represents an incremental increase over 2018, it remains well-below the Healthy People goal. Furthermore, HPV vaccine ordering and administration have dropped dramatically during the COVID-19 pandemic.

Preoperative Education and Informed Consent in Young Adults Undergoing Bariatric Surgery: Patients’ Perspectives on Current Practice
Wouter K.G. Leclercq, Daniëlle S. Bonouvrie, Charlotte E.J.M. Dohmen, Martine Uittenbogaart, Johan Legemaate, Laurents P.S. Stassen, and François M.H. van Dielen
Bariatric Surgical Practice and Patient Care, 31 December 2020
Abstract
Background
Preoperative education is part of the informed consent process and should enable patients to make an informed decision. Aim of this study was to gain a more detailed insight in the perceptions and experiences of the informed consent process of young adults undergoing bariatric surgery.
Methods
Fifty-five young adults, aged 18–25 years, who underwent bariatric surgery, were invited to participate in a semistructured interview. The interview covered three main topics: education of specific informed consent domains, perioperative expectations and experiences, and personal (un)certainties related to undergoing bariatric surgery.
Results
Twenty-seven patients participated in a semistructured interview. Mean age was 23.1 ± 1.6 years. All consent domains were remembered by the patients, but 24/27 patients could not recall one or more complications. Inadequate weight loss was not recalled by 6/27 patients. Common remarks were that the preoperative education focused mainly on the positive results. Negative effects were inadequately educated.
Conclusions
Physicians should educate patients more about the negative effects of a treatment and should focus more on specific age-related problems and social interactions. Improved preoperative education, including possible outcome scenarios to assess risks and lifetime consequences, should be developed to improve informed consent in these patients.

Digital Age of Consent and Age Verification: Can They Protect Children?
Liliana Pasquale, Paola Zippo, Cliona Curley, Brian O’Neill, Marina Mongiello
IEEE Software, 15 December 2020
Abstract
Children are increasingly accessing social media content through mobile devices. Existing data protection regulations have focused on defining the digital age of consent, in order to limit collection of children’s personal data by organizations. However, children can easily bypass the mechanisms adopted by apps to verify their age, and thereby be exposed to privacy and safety threats. We conducted a study to identify how the top 10 social and communication apps among underage users apply age limits in their Terms of Use. We also assess the robustness of the mechanisms these apps put in place to verify the age of their users. Moreover, we discuss how automated age recognition techniques can be adopted to increase the effectiveness of the age verification process. Finally, we provide recommendations to app providers and developers to specify the Terms of Use and implement robust age verification mechanisms.

Editor’s note: IEEE Software delivers software development information. The articles in this journal are peer reviewed in accordance with the requirements set forth in the IEEE PSPB Operations Manual.