[The consent of adolescents in an outpatient setting].
Soins Psychiatrie, 23 March 2021; 42(333) pp 23-25
The part-time therapeutic reception center (CATTP) presented in this article has modified its organization in order to retain the adolescents who attend it. Clinical work on indications and the implementation of a reception protocol mobilized the team in view of admissions. The CATTP, in its current functioning, brings together the adolescent and his family, in search of a double consent.
Editor’s note: This is a French language publication
Social Media Terms and Conditions and Informed Consent From Children: Ethical Analysis
Christophe Olivier Schneble, Maddalena Favaretto, Bernice Simonne Elger, David Martin Shaw
JMIR Pediatrics and Parenting, 22 April 2021; 4(2)
Terms and conditions define the relationship between social media companies and users. However, these legal agreements are long and written in a complex language. It remains questionable whether users understand the terms and conditions and are aware of the consequences of joining such a network. With children from a young age interacting with social media, companies are acquiring large amounts of data, resulting in longitudinal data sets that most researchers can only dream of. The use of social media by children is highly relevant to their mental and physical health for 2 reasons: their health can be adversely affected by social media and their data can be used to conduct health research.
The aim of this paper is to offer an ethical analysis of how the most common social media apps and services inform users and obtain their consent regarding privacy and other issues and to discuss how lessons from research ethics can lead to trusted partnerships between users and social media companies. Our paper focuses on children, who represent a sensitive group among users of social media platforms.
A thematic analysis of the terms and conditions of the 20 most popular social media platforms and the 2 predominant mobile phone ecosystems (Android and iOS) was conducted. The results of this analysis served as the basis for scoring these platforms.
The analysis showed that most platforms comply with the age requirements issued by legislators. However, the consent process during sign-up was not taken seriously. Terms and conditions are often too long and difficult to understand, especially for younger users. The same applies to age verification, which is not realized proactively but instead relies on other users who report underaged users.
This study reveals that social media networks are still lacking in many respects regarding the adequate protection of children. Consent procedures are flawed because they are too complex, and in some cases, children can create social media accounts without sufficient age verification or parental oversight. Adopting measures based on key ethical principles will safeguard the health and well-being of children. This could mean standardizing the registration process in accordance with modern research ethics procedures: give users the key facts that they need in a format that can be read easily and quickly, rather than forcing them to wade through chapters of legal language that they cannot understand. Improving these processes would help safeguard the mental health of children and other social media users.
Implementing new consent procedures for schools-based human papillomavirus vaccination: a qualitative study
Suzanne Audrey, Karen Evans, Michelle Farr, Joanne Ferrie, Julie Yates, Marion Roderick, Harriet Fisher
British Journal of Child Health, 10 April 2021; 2(2)
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.
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.
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.
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.
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
This study aims to understand primary caregivers’ (PCG) experience with the informed consent (IC) process.
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.
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.
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)
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
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
Sage Research Methods, 17 September 2019
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.
Beyond Montgomery – decision making, consent and the GMC
Anastasia Georgiou, Helen Bolton
Obstetrics, Gynaecology & Reproductive Medicine, 17 April 2021
In November 2020 the General Medical Council (GMC) updated its guidance on decision making and consent. This new document reflects significant legal and ethical developments that have occurred in recent years. It is helpful to understand the context from which this guidance has arisen, and imperative to understand the implications it will have on clinical practice. As such, this article will (i) outline the evolution of consent (ii) briefly explain the landmark case of Montgomery and (iii) highlight the key updates in the GMC’s 2020 guidance.
Changing FDA Approval Standards: Ethical Implications for Patient Consent
Jonathan J. Darrow, Sanket S. Dhruva, Rita F. Redberg
Journal of General Internal Medicine, 8 April 2021
The pace of new drug and medical device introductions has accelerated in recent years. In 2018, 59 novel drugs were approved in the USA, the most since 1996. A rising proportion of drugs and devices qualify for one of the US Food and Drug Administration’s (FDA) expedited programs, which allow approval based on less rigorous clinical trials. Expanded access and emergency use authorization allow access to products—such as remdesivir (Veklury) and COVID-19 vaccines—even before they are approved.
The growing array of products made available with limited evidence poses important challenges for patients and physicians. Ethical principles require that patients consent to treatment after being informed of the benefits and harms of each alternative. In routine practice, however, the consent process is often truncated, with limited presentation of alternatives, risks, and outcome data. As regulatory processes have evolved, the consent process—already criticized by some as inadequate—has changed little. We review the evolution of drug and device evidence requirements and consider the implications for informed consent…
Knowledge and practices of seeking informed consent for medical examinations and procedures by health workers in the Democratic Republic of Congo
Doudou Nzaumvila, Patrick Ntotolo, Indiran Govender, Philip lukanu, JD Landu Niati, Didier Sanduku, Tombo Bongongo
African Journals Online, 16 April 2021; 21(1)
Informed consent (IC) is linked to the ethical principle of respecting patient autonomy, respect for human rights and ethical practice, while in many countries it is a standard procedure. Anecdotally, it should be noted that in the Democratic Republic of Congo (DRC) in many instances ICs are not obtained systematically. To date, no research appears to have been conducted on this matter. This study aimed to assess the knowledge and practice of obtaining IC from patients among health care providers (HCP) in the DRC.
This was a cross-sectional study, with a convenient sampling of 422 participants. Data from the questions were collected on an imported Microsoft Excel spreadsheet for review at INSTAT.TM The authors set IC’s accurate knowledge and practice at 80% or higher. The Fisher Exact test was used to compare categorical association results, and a p-value < 0.05 was considered statistically significant.
Results showed that giving information in detail to patients on their medical condition was associated with formal training on medical ethics and IC (p: 0.0028; OR: 1.894; CI: 1.246 to 2.881), which was also associated with answering the patient’s questions in detail (p: 0.0035; OR: 1.852; CI: 1.236 to 2.774). About 127(30.09 %) of participants scored 80% or higher. Extracurricular training was associated with withholding information from patients, up to 27 times more than other factors (p< 0.0001; OR: 27.042; CI: 13.628 to 53.657). when it comes to get IC, HCP with many years of practice scored better than others, in one of the question the odd ratio was closer to 7 ( p< 0.0001; OR: 6.713; CI: 4.352 to 10.356). Only 47(11.14%) of the participants scored 80% or more of the questions about practice of IC.
For a variety of reasons, knowledge and practice of IC among HCPs was very low. A common programme for the country as part of formal training might lead to an improvement. In addition, patients’ education on IC should be displayed in waiting areas at all medical centres.