“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
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
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.