The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation [BOOK]

The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation [BOOK]
Fiona Mayne, Christine Howitt
Routledge, 16 November 2021
Abstract
    The Narrative Approach to Informed Consent: Empowering Young Children’s Rights and Meaningful Participation is a practical guide for researchers who want to engage young children in rights-based, participatory research. This book presents the Narrative Approach, an original and innovative method to help children understand their participation in research. This approach moves away from traditional paper-based consent to tailor the informed consent process to the specific needs of young children. Through the Informing Story, which employs a combination of interaction, information and narrative, this method enables children to comprehend concepts through storytelling. Researchers are stepped through the development of an Informing Story so that they can deliver accurate information to young children about what their participation in research is likely to involve. To further inform practice, the book documents the implementation of the Narrative Approach in four case studies demonstrating the variety of settings in which the method can be applied.

The Narrative Approach to Informed Consent addresses the rights of young children to be properly researched, expands opportunities for their active and engaged research participation, and creates a unique conceptual ethical space within which meaningful informed consent can occur. This book will be an invaluable tool for novice and experienced researchers and is applicable to a wide range of education and non-education contexts.

Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review

Transparent reporting of recruitment and informed consent approaches in clinical trials recruiting children with minor parents in sub-Saharan Africa: a secondary analysis based on a systematic review
Research Article
Angela De Pretto-Lazarova, Domnita Oana Brancati-Badarau, Christian Burri
BMC Public Health, 28 July 2021; 21(1473)
Open Access
Abstract
Background
Standardised checklists of items to be addressed in clinical study protocols and publications are promoting transparency in research. However, particular specifications for exceptional cases, such as children with minor parents are missing. This study aimed to examine the level of transparency regarding recruitment and informed consent approaches in publications of clinical trials recruiting children with minor parents in sub-Saharan Africa. We thereby focused particularly on the transparency about consenting persons (i.e. proxy decision-makers) and assessed the need to expand reporting guidelines for such exceptional cases.
Methods
We conducted a secondary analysis of clinical trial publications previously identified through a systematic review. Multiple scientific databases were searched up to March 2019. Clinical trial publications addressing consent and potentially recruiting children with minor parents in sub-Saharan Africa were included. 44 of the in total 4382 screened articles met our inclusion criteria. A descriptive analysis was performed.
Results
None of the included articles provided full evidence on whether any recruited children had minor parents and how consent was obtained for them. Four proxy decision-maker types were identified (parents; parents or guardians; guardians; or caregivers), with further descriptions provided rarely and mostly in referenced clinical trial registrations or protocols. Also, terminology describing proxy decision-makers was often used inconsistently.
Conclusions
Reporting the minimum maternal age alongside maternal data provided in baseline demographics can increase transparency on the recruitment of children with minor mothers. The CONSORT checklist should require clinical trial publications to state or reference exceptional informed consent procedures applied for special population groups. A standardized definition of proxy decision-maker types in international clinical trial guidelines would facilitate correct and transparent informed consent for children and children with minor parents.

Age-of-Consent Policies and HIV Among Adolescents in SubSahara Africa [DISSERTATION]

Age-of-Consent Policies and HIV Among Adolescents in SubSahara Africa [DISSERTATION]
Suzanne Marie King
Walden University, 2021
Open Access
Abstract
Age of consent policies have recently been identified as a barrier to HIV testing among adolescents in HIV endemic Sub-Sahara Africa. Grounded in the modified social ecological model, the purpose of this study was to determine if these policies were related to HIV testing rates and prevalence. In this quantitative research secondary data sets from the Demographic Health Survey were used. This study included all sexually active respondents aged 18 years or below (N=37,015) and then was further limited by respondents that had HIV test results (N=25,107). Binary logistic regression showed that respondents with lower age of consent had higher rates of HIV testing. Compared to respondents with an age of consent of 18 years, respondents with age of consent of 16 were 3 times more likely to have been tested (p<0.001, OR 2.876, 95% CI [2.697, 3.067]), age of consent of 15 were 1.5 times more likely to be tested, age of consent of 14 were 0.5 times less likely to be tested, age of consent of 13 were 5 times more likely to be tested, age of consent of 12 were 3 times more likely to be tested, and age of consent of 11 were 2 times more likely to have been tested. Age of consent was also related to HIV prevalence. For each year decrease in age of consent, odds of being HIV positive increased by 1.2%. The outcomes of this study showed further relationships between HIV testing and age of consent policies. This research can be used to inform updated age of consent policies to ensure that all adolescents can access HIV testing. This research could shed light on the importance of HIV testing for adolescents, their families, and their communities leading to positive social change.

Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process

Can I Share Your Ideas With the World? Young Children’s Consent in the Research Process
Sonya Gaches
Journal of Childhood Studies, July 2021; 46(2)
Open Access
Abstract
Utilizing the four features of informed consent from the guiding document Ethical Research Involving Children, the article illustrates how the informed consent process was carried out with young children from the initial planning stages through the ongoing research’s focused conversations. Specifically, the questions of what would be needed to acquire informed consent from the children and what assurances could there be that young children understood the research and how its results would be disseminated are addressed. The article concludes with suggestions for what other researchers might consider and include in their local contexts.

Editor’s note: The abstract references the 2013 unicef report Ethical Research Involving Children.

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
Abstract
Background
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.
Methods
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.
Results
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.
Conclusions
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
Abstract
Objectives
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.
Methods
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.
Results
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.
Conclusions
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
Excerpt
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
Commentary
Julien Brisson, Vardit Ravitsky, Bryn Williams-Jones
Journal of Adolescent Health, 1 June 2021; 68(6) pp 1038-1039
Excerpt
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
Abstract
Importance
Obtaining voluntary informed consent prior to enrollment in clinical trials is a fundamental ethical requirement.
Objective
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.
Exposures
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.
Results
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
Abstract
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.