Facilitators and barriers for parental consent to pediatric emergency research

Facilitators and barriers for parental consent to pediatric emergency research
Clinical Research Article
Reagan L. Miller, R. Dawn Comstock, Lauren Pierpoint, Jan Leonard, Lalit Bajaj, Rakesh D. Mistry
Pediatric Research, 4 June 2021
Obtaining informed consent for clinical research in the pediatric emergency department (ED) is challenging. Our objective was to understand the factors that influence parental consent for ED studies.
This was a cross-sectional survey assessing parents’ willingness to enroll their children into an ED research study. Parents reporting a willingness to enroll in ED studies were presented with two hypothetical scenarios, a low-risk and a high-risk study, and then asked about decision influencers affecting consent. Parents expressing a lack of willingness to enroll were asked which decision influencers impacted their consent decision.
Among 118 parents, 90 (76%) stated they would be willing to enroll their child into an ED study; of these, 86 (96%) would consent for a low-risk study and 54 (60%) would consent for a high-risk study. Caucasian parents, and those with previous research exposure, were more likely to report willingness to participate. Those who would consent to the high-risk study cited “benefits that research would provide to future children” most strongly influenced their decision to agree.
ED investigators should highlight the benefits for future children and inquire about parents’ previous exposure to research to enhance ED research enrollment. Barriers to consent in non-Caucasian families should be further investigated.

Late adolescents’ own and assumed parental preferences towards health-care related confidentiality and consent in Belgium

Late adolescents’ own and assumed parental preferences towards health-care related confidentiality and consent in Belgium
David De Coninck, Koen Matthijs, Peter de Winter, Jaan Toelen
PLoS One, 2 June 2021
Health care professionals regularly struggle with issues relating to confidentiality and consent for physical and/or mental health issues among adolescents. We investigate late adolescents’ own and assumed parental preferences towards health-care related confidentiality and consent.
We analyzed online survey data of four vignettes from 463 first-year university students at KU Leuven (Flanders, Belgium). We used paired samples t-tests to assess the (in)consistency between attitudes of late adolescents and their assumed parental attitudes, independent samples t-tests to estimate gender differences, and binomial logistic regressions to analyze the association of assumed parental preferences with late adolescents’ own preferences.
Attitudinal inconsistencies were present in all vignettes. Late adolescents were significantly more in favor of confidentiality and adolescent consent than what they believed their parents were. Gender differences were limited. Binomial logistic regressions indicated that assumed parental preferences were strongly associated with late adolescents’ own preferences.
Findings suggest a clear difference between late adolescents’ preferences and assumed parental preferences: they believe that their parents are less inclined to favor confidentiality and adolescent consent. We also find that this difference depends on the case, indicating that there is no such thing as general ‘confidentiality preferences’. Rather, a decision- and/or context-specific perspective should be adopted.

Soliciting parental consent among adolescent minor mothers: A barrier in adolescent HIV research?

Soliciting parental consent among adolescent minor mothers: A barrier in adolescent HIV research?
L T Gebrekristos
South African Medical Journal, May 2021; 111(6) pp 526-527
Open Access
Adolescents fare worse on the HIV prevention and treatment cascade than adults. This disparity may be particularly acute for adolescent minors (i.e. <18 years of age). Current trends show that adolescents, and especially adolescent minors, are a particularly vulnerable population. The under-representation of adolescent minors (especially unemancipated induviduals) in HIV research negatively affects the development and evaluation of interventions to improve their health. Despite growing consensus regarding the value of conducting HIV research with adolescent minors, concerns about perceived barriers to enrolling them persists. Specifically, researchers and adolescnets minors in studies have voices concerns that requiring parental consent might affect adolescent minors’ autonomy and/or confidentiality…

“Fostering Autonomy” for Adolescents to Access Health Services: A Need for Clarifications

“Fostering Autonomy” for Adolescents to Access Health Services: A Need for Clarifications
Julien Brisson, Vardit Ravitsky, Bryn Williams-Jones
Journal of Adolescent Health, 1 June 2021; 68(6) pp 1038-1039
The global health literature studying adolescent health issues has shown that adolescents are among the groups that least use health services despite having serious health-related needs [[1]]. To help promote adolescent health, the World Health Organization’s Global Accelerate Action for the Health of Adolescents advocates implementing measures to “foster the autonomy” of adolescents to access health services ([[2]], p.93). The argument is persuasive: protect the well-being of adolescents. However, there are significant challenges to understanding what is actually meant by “fostering autonomy” and the possible or necessary steps required for adolescents to be able to both choose and have access to health services. For example, fostering autonomy could entail the development of decision-making skills (e.g., knowing how, when, and where to access health services) or the implementation of enabling policies to make health services more accessible for adolescents, such as removing financial or geographic barriers that impede access…

Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials

Assessment of Factors Associated With Parental Perceptions of Voluntary Decisions About Child Participation in Leukemia Clinical Trials
Original Investigation
Paula Aristizabal, Arissa K. Ma, Nikhil V. Kumar
JAMA Network Open, 4 May 2021; 4(5)
Open Access
Obtaining voluntary informed consent prior to enrollment in clinical trials is a fundamental ethical requirement.
To assess whether health literacy, contextual factors, or sociodemographic characteristics are associated with perception of voluntariness among parents who had consented for their child’s participation in a leukemia therapeutic clinical trial.
Design, Setting, and Participants
This cross-sectional study prospectively enrolled 97 parents of children diagnosed as having leukemia at Rady Children’s Hospital San Diego, a large tertiary academic center in California, from 2014 to 2017. Health literacy, contextual factors (acculturation, decisional regret, and satisfaction with informed consent), sociodemographic characteristics, and perception of voluntariness after consenting for a therapeutic clinical trial were measured. Univariable and multivariable regression were used to determine significant associations. The analyses for the present study were conducted from May 2019 to May 2020.
Informed consent for a therapeutic leukemia clinical trial.
Main Outcomes and Measures
The primary outcome of interest was perception of voluntariness and its associations with health literacy and other contextual factors (acculturation, decisional regret, and satisfaction with informed consent) and sociodemographic characteristics, including age, race/ethnicity, parental language, educational level, insurance type, marital status, and socioeconomic status.
Of 97 parents included, the majority were women (65 [67%]), married (71 [73%]), and of self-reported Hispanic ethnicity (50 [52%]). Lower perception of voluntariness was significantly associated with lower health literacy (r = 0.30; 95% CI, 0.11-0.47; P = .004), Spanish language (x̅ = −4.50, P = .05), lower acculturation if of Hispanic ethnicity (r = 0.30; 95% CI, 0.02-0.54; P = .05), greater decisional regret (r = −0.54; 95% CI, −0.67 to −0.38; P < .001), and lower satisfaction with informed consent (r = 0.39; 95% CI, 0.21-0.54; P < .001) in univariable analysis. Lower health literacy remained significantly associated with lower perception of voluntariness in multivariable analysis after adjustment for contextual factors and sociodemographic characteristics (β = 4.06; 95% CI, 1.60-6.53; P = .001). Lower health literacy was significantly associated with Hispanic ethnicity (mean, 4.16; 95% CI, 3.75-4.57; P < .001), Spanish language spoken at home (mean, 3.17; 95% CI, 1.94-4.40; P < .001), high school or less educational level (mean, 3.41; 95% CI, 2.83-3.99; P < .001), public insurance (mean, 4.00; 95% CI, 3.55-4.45; P < .001), and unmarried status (mean, 3.71; 95% CI, 2.91-4.51; P = .03).
Conclusions and Relevance
Among parents of children with newly diagnosed leukemia who had consented for their child’s participation in a therapeutic clinical trial, lower perception of voluntariness was significantly associated with lower health literacy. These results suggest that parents with low health literacy may perceive external influences in their decision for their child’s participation in clinical trials. This finding highlights the potential role of recruitment interventions tailored to the participant’s health literacy level to improve voluntary informed consent in underserved populations.

Negotiating the practicalities of informed consent in the field with children and young people: learning from social science researchers

Negotiating the practicalities of informed consent in the field with children and young people: learning from social science researchers
Gina Sherwood, Sarah Parsons
Research Ethics, 12 April 2021
Open Access
The real-world navigation of ethics-in-practice versus the bureaucracy of institutional ethics remains challenging. This is especially true for research with children and young people who may be considered vulnerable by the policies and procedures of ethics committees but agentic by researchers. Greater transparency is needed about how this tension is navigated in practice to provide confidence and effective strategies for social researchers, including those new to the field, for negotiating informed consent. Twenty-three social science researchers with a range of experience were interviewed about their practices for gaining informed consent from children and young people in social research and the development of their ‘ethics in practice’ over time. Main themes focused on navigating ethics protocols within institutions, practices to prepare for data collection, and a critical evaluation of the resources that can be applied to gaining consent and managing relationships. A range of methods and concrete steps that address ethical challenges are outlined to illustrate what can be done in practice to achieve authentic consent and appropriate participation.

Implementing new consent procedures for the schools-based HPV vaccination programme: a qualitative study

Implementing new consent procedures for the schools-based HPV vaccination programme: a qualitative study
Suzanne Audrey, Karen Evans, Michelle C Farr, Joanne Ferrie, Julie Yates, Marion R Roderick, Harri Fisher
British Journal of Child Health, 22 February 2021
The English schools-based human papillomavirus (HPV) programme was offered to young women aged 12-13 years. High coverage was achieved, but variations in uptake across local authorities were apparent. The requirement for written parental consent acted as a barrier to some young women with the potential to exacerbate health inequities.
To consider the practicalities and implications of implementing new consent procedures for the schools-based HPV vaccination programme.
Qualitative study.
Two local authority areas in the south-west of England with relatively lower uptake of the HPV vaccination programme.
The 53 participants included: the immunisation programme manager, three immunisation nurses, three members of staff in mainstream schools, five members of staff in alternative education provider settings, 19 young women, and 22 parents.
Digitally recorded, semi-structured interviews were undertaken. All transcripts were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management.
The new consent processes for the HPV vaccination generally worked well. Telephoning parents on the day of the vaccination session was viewed as an acceptable and effective way to reach parents. Adolescent self-consent was rarely undertaken. This can be explained partially by the relative success in gaining parental verbal consent but concerns about disrupting relationships – between healthcare professionals, parents and school staff, or within families – made professionals reluctant to administer the vaccine without some form of parental consent. For young women with special educational needs and disabilities the consent process relied upon close communication between school staff and parents. Other young women whose access to the vaccine, or consent options, were unclear or problematic included: those who were registered with a school but attended an alternative setting for part of their timetable; those educated at home; those in the care of the local authority or living with a foster family, and; young people with gender dysphoria.
Expanding the consent procedures for the schools-based HPV vaccination programme to include parental telephone consent was broadly welcomed by the immunisation nurses, parents, and young women in our study. The requirement for young women to confirm that they had discussed vaccination with their parents, and that vaccination would not cause difficulties at home, meant adolescent self-consent was rare in this age-group. Greater understanding of the barriers to uptake outside of the mainstream school-based sessions is needed to further address inequalities in uptake.

Consent, refusal of care, and shared decision-making for pediatric patients in emergency settings

Consent, refusal of care, and shared decision-making for pediatric patients in emergency settings
Morrison SN, Sigman L
Pediatric Emergency Medicine Practice, 2 May 2021, 18(5) pp 1-20
Involving patients or their surrogate decision-makers in their care is an important element of modern medical practice. General consent, informed consent, treatment refusal, and shared decision-making are concepts that are used regularly but can be more complex in pediatric emergency settings. This issue summarizes these concepts and provides case examples that may be encountered. It explains the essential elements of informed consent, the distinction between the informed consent process and the document, how to approach treatment refusal, and approaches to involving patients and their surrogates in shared decision-making. Special circumstances include treatment for sexual and mental health conditions, emancipated minors, mature minors, and situations when custody is unclear. Implementation of these concepts can increase patient satisfaction, resolve conflict, and reduce risk.

[The consent of adolescents in an outpatient setting].

[The consent of adolescents in an outpatient setting].
Desmarets-Malik V
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

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)
Open Access
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.