Research ethics committee members’ perspectives on paediatric research: a qualitative interview study
Kajsa Norberg Wieslander, Anna T Höglund, Sara Frygner-Holm, Tove Godskesen
Research Ethics, 2023
Abstract
Research ethics committees (RECs) have a crucial role in protecting children in research. However, studies on REC members’ perspectives on paediatric research are scarce. We conducted a qualitative study to explore Swedish scientific REC members’ perspectives on ethical aspects in applications involving children with severe health conditions. The REC members considered promoting participation, protecting children and regulatory adherence to be central aspects. The results underscored the importance of not neglecting ill children’s rights to adapted information and participation. REC members supported a contextual and holistic approach to vulnerability and risk, which considers the child’s and parents’ psychological wellbeing and the child’s integrity, both short and long term. The ethical complexity of paediatric research requires continuous ethical competence development within RECs.

The psychoanalytic frame and the consent situation: the child patient’s position in the publication dilemma
Research Article
Michael Garcia
Journal of Child Psychotherapy, 12 May 2023
Abstract
The author explores the current dilemma regarding consent standards for the publication of child patient clinical material, and the psychic impact on the child when seeking permission to publish. It is proposed that a psychoanalytic view creates an additional dimension to the more universal ethic of ‘do no harm’, requiring clinicians to consider the unconscious experience of the patient as the core of the matter. The term consent situation is introduced to describe the way in which providing a draft of the clinician’s writing about the patient’s experience in treatment, and then asking the patient and family for permission to publish it, subjects them to external realities of an oedipal nature, compromising the frame around the treatment, and the vital cycle of the containing function in the treatment. The frame could potentially be compromised from the beginning in the form of a leaky container, during the treatment as a betrayal of the frame, or after the treatment has ended as an intrusion into the containing object. The author shows how this is a burden to all young patients that could be collectively carried by the professional community, by using creative modifications to systems of professional development and publishing.

Medical staff’s sense of awareness of informed consent for adolescent cancer patients and the need for decision-making support practiced from the perspective of trauma-informed approach
Research
Kyoko Tanaka, Maoko Hayakawa, Makiko Mori, Naoko Maeda, Masako Nagata, Keizo Horibe
BMC Medical Ethics, 6 May 2023; 24(28)
Open Access
Abstract
It has not been established how to assess children’s and adolescents’ decision-making capacity (DMC) and there has been little discussion on the way their decision-making (DM). The purpose of this study was to examine actual situation and factors related to difficulties in explaining their disease to adolescent cancer patients or obtaining informed consent (IC). The cross-sectional questionnaire survey was conducted. Physicians who have been treating adolescent cancer patients for at least five years answered a self-administered questionnaire uniquely developed about clinical difficulties in explaining, IC and factors related patient’s refusal of medical treatment (RMT). Descriptive statistics for each item and a polychoric correlation analysis of the problems and factors related to the explanation were conducted. As a result, fifty-six physicians were participated (rate of return: 39%). Explaining the disease and treatment to patients (83.9%), IC to patients (80.4%), and explaining the disease and treatment to parents (78.6%) was particularly problematic. Difficulties to provide support related with patient’s refusal of medical treatment and to explain disease and treatment for patient and parents were related to difficulties obtaining IC for the patient. Conclusion: There are clinically difficult to explain for the patient or parents and to obtain IC for the patient. It is necessary to establish a disease acceptance assessment tool for the adolescent generation so that it can be applied in the field.

Editor’s note: We acknowledge the grammatical inconsistencies in this abstract.

Parental Engagement in Consent Processes for Enrollment in Biomedical HIV Prevention Trials: Implications for Minor Adolescents’ Willingness to Participate
Original Article
Amelia Knopf, Claire Burke Draucker, J. Dennis Fortenberry, Mary A. Ott, Renata Arrington-Sanders, Daniel Reirden, John Schneider, Diane Straub, Susan Ofner, Giorgos Bakoyannis, Gregory Zimet
Journal of Adolescent Health, May 2023; 72(5) pp 703-711
Abstract
Purpose
Minor adolescents are often excluded from HIV prevention clinical trials due to unresolved ethical issues. Their under-representation in research leads to delayed access to new HIV prevention approaches. We examine the relationship between consent procedures, trial features, demographic and social characteristics, and minor adolescents’ willingness to participate (WTP) in biomedical HIV prevention research.
Methods
We recruited 14–17-year-olds at risk of HIV for this quasi-experimental study. Adolescents were randomly assigned to (1) self-consent, (2) adult permission required, or (3) parental permission required and underwent simulated consent procedures for two types of HIV prevention trials. They rated likelihood of participating in each study if offered the opportunity and completed a survey with demographic, social, and behavioral measures.
Results
One hundred and twenty nine adolescents with diverse identities and socioeconomic status enrolled. Among the 58% of participants who identified as lesbian, gay, bisexual, transgender, or queer (LGBTQ), 76% were out to at least one parent/guardian (outness). Mean WTP was 3.6 (of 5; 5 = definitely would participate) across all participants and both trial types. We found no evidence of an association between WTP and consent condition, LGBTQ identity, or outness. However, medical mistrust, communication with parents, and concern about HIV were associated with WTP.
Discussion
Our results suggest adolescents are willing to participate in HIV prevention trials and parental involvement in the consent process may not be the most important deciding factor. However, variation in WTP within consent groups, and variation in other significant variables, underscores the need for individualized approaches to recruitment and consent for these trials.

Editor’s note: This is a US based publication.

Children must co-design digital health research
Editorial
The Lancet Digital Health, 7 April 2023
Open Access
Excerpt
… A multipronged approach is needed to change prevalent risk behaviours in adolescents. Yet few eHealth studies have assessed whether multiple health behaviour change (MHBC) interventions work, even though risk behaviours commonly co-occur, with more than 80% of adolescents engaging in two or more risk behaviours and more than 33% engaging in three or more. In this issue, Katrina Champion and colleagues describe a cluster randomised trial in Australia of more than 6000 11–13-year-olds enrolled in a 6-week school-based MHBC web-based and app-based intervention (Health4Life) designed to modify six chronic disease risk behaviours. The trial showed that the intervention was not effective in modifying adolescent risk behaviours despite improving knowledge about chronic disease risk factors over 24 months. These results are consistent with a previous meta-analysis by the authors, showing that eHealth MHBC interventions were not effective in reducing alcohol use, smoking, or sugar-sweetened beverage intake among school students. But, why do so many of these digital interventions fail?…

Informed Consent, Assent, and Confidentiality
Book Chapter
Eron Linver
Caring for the Hospitalized Child, May 2023 [American Academy of Pediatrics]
Excerpt
Informed consent is defined as the voluntary agreement of an individual or their authorized representative who has the legal authority to give such agreement. This consent must be exercised within the context of free choice, without any application of inducement or coercion. To give informed consent, an individual must have sufficient knowledge and understanding to be able to make a knowledgeable decision. Health care providers may have a different level of education and understanding than patients and their guardians. This knowledge gap can add complexity and potential misunderstandings to conversations surrounding informed consent…

Consent for the paediatric patient
Andrew Jones, James Hyde, Sharon Lee, Sondos Albadri, Laura Gartshore
Faculty Dental Journal, 1 April 2023; 14(2)
Abstract
Introduction
Obtaining valid consent is a fundamental process in dentistry. Written consent must be obtained where treatment involves conscious sedation or general anaesthesia. For children, consent may be provided by a person with parental responsibility (PR).
Methods
A retrospective evaluation was completed of 160 children over 2 UK hospital sites with paediatric services. Cases involving conscious sedation or general anaesthesia for dental treatment were selected. Data were obtained to establish whether it was documented that the correct person had provided consent for a child and whether all possible individuals with PR for the child were identified at the initial visit. UK national legislation and guidance was reviewed, from which a PR form (to determine PR status for a child) was created and implemented. A second evaluation was subsequently completed, again with 160 children.
Results
Combined data from both sites confirmed documentation of an appropriate person providing consent in 127 cases (79%) in the first evaluation. This improved to 155 cases (97%) following implementation of the PR form. All possible individuals who had PR for the child were identified at the initial visit in 35 cases (22%). This improved to 139 cases (87%) following the introduction of the PR form.
Conclusions
Use of a PR form improved documentation regarding valid consent for children.

Editor’s note: This is a publication from the Royals College of Surgeons England.

Parents’ and child welfare workers’ understandings of consent to emergency placements
Research Article
A.S. Storhaug, M.K. Fylkesnes, E. Langsrud, Ø. Christiansen
Nordic Social Work Research, 22 March 2023
Abstract
Emergency placements of children are often made in haste and experienced as dramatic. This article is based on interviews with 9 parents who have consented to emergency placements and their caseworkers. We explore parents’ reasons for giving their consent to placement and the child welfare workers’ understanding of these consents. This leads to a discussion of what constitutes valid consent from parents in emergency cases. Relational autonomy is applied as a perspective to understand the context and influencing factors of parental consent. The results, derived by thematic analysis, show three main themes regarding parents’ reasons for their consent: (1) The child wanted to move out, (2) the parents couldn’t manage the situation, and (3) parents felt the child welfare service (CWS) gave them no choice. Parents experience a high degree of pressure in the context of giving their consent, either from their child or the CWS. Asymmetrical power dynamics between the CWS and parents were highly present and relevant in parents’ reasons for consent, especially when the CWS communicated that the alternative to consent is coercive placement. Furthermore, it is often unclear to the parents what consent entails. This is especially evident through CWS’s regulation of child-parent contact. In the discussion, we emphasize a high degree of awareness on the part of CW workers with regards to understanding how contextual and relational factors influence parent’s choice to consent; when consent is valid; how far consent extends, and the potential weakening of parents’ legal security when a voluntary placement is conducted.

Perceptions of pediatric deceased donor consent: A survey of organ procurement organizations
Gretchen B Chapman, Alison Butler, Mandy Lanyon, Justin Godown, Daniel J Lebovitz
Pediatric Transplant, 21 March 2023
Abstract
Background
Children awaiting transplantation face a high risk of waitlist mortality due to a shortage of pediatric organ donors. Pediatric donation consent rates vary across Organ Procurement Organizations (OPOs), suggesting that some OPOs might utilize more effective pediatric-focused donor recruitment techniques than others. An online survey of 193 donation requestor staff sheds light on the strategies that OPO staff utilize when approaching potential pediatric deceased organ donors.
Methods
In collaboration with the Association of Organ Procurement Organizations, the research team contacted the executive directors and medical directors of all 57 of the OPOs in the US. Of these, 51 OPOs agreed to participate, and 47 provided contact information for donation requestor staff. Of the 379 staff invited to participate in the survey, 193 provided complete responses.
Results
Respondents indicated more comfort approaching adult donors than pediatric donors, and they endorsed approach techniques that were interpersonal and emotional rather than professional and informative. Respondents were accurate in their perceptions about which donor characteristics are associated with consent. However, respondents from OPOs with high consent rates (according to data from the Scientific Registry of Transplant Recipients), and those from OPOs with low consent rates were very similar in terms of demographics, training, experience, and reported techniques.
Conclusions
Additional research is needed to better determine why some OPOs have higher consent rates than others and whether the factors that lead to high consent rates in high-performing OPOs can be successful when implemented by lower-performing OPOs.