Caregiver Perspectives on Informed Consent for a Pediatric Learning Healthcare System Model of Care
Research Article
E. Pritchard, T. A. Zabel, L. A. Jacobson, E. Jones, C. Holingue, L. G. Kalb
AJOB Empirical Bioethics, 26 October 2020
Abstract
Background
Data is needed to provide insight into the issue of preference around consent for use of pediatric clinical data for research. This study evaluated caregivers’ preferences concerning use of their child’s clinical information.
Methods
Caregivers of children (n = 101; response rate 81.5% of n = 124) presenting for psychological evaluation at an urban medical center viewed a video regarding how the information contained in their child’s medical record could be used for research.
Results
An anonymous survey following the video indicated that: 1) >90% of caregivers felt comfortable with their child’s information being used; 2) >90% of caregivers felt their child’s privacy would be adequately protected; 3) 98% of caregivers reported themselves to be as or more likely to return to the institution after viewing the video; 4) 60% of caregivers felt no additional consent procedures beyond viewing the video were needed, while 20% preferred an opt-out and 20% preferred a traditional consent procedure. Caregiver demographic variables were largely unrelated to consent preferences.
Discussion
Overall, caregivers reported strong support for use of their child’s clinical data for research purposes.

Issues of consent and assent in pediatric neurosurgery
Review Article
Rajeev D. Sen, Amy Lee, Samuel R. Browd, Richard G. Ellenbogen, Jason S. Hauptman
Child’s Nervous System, 17 October 2020
Abstract
Background
Consent and assent are important concepts to understand in the care of pediatric neurosurgery patients. Recently it has been recommended that although pediatric patients generally do not have the legal capacity to make medical decisions, they be encouraged to be involved in their own care. Given the paucity of information on this topic in the neurosurgery community, the objective is to provide pediatric neurosurgeons with recommendations on how to involve their patients in medical decision-making.
Methods
We review the essential elements and current guidelines of consent and assent for pediatric patients using illustrative neurosurgical case vignettes.
Results
The pediatric population ranges widely in cognitive and psychological development making the process of consent and assent quite complex. The role of the child or adolescent in medical decision-making, issues associated with obtaining assent or dissent, and informed refusal of treatment are considered.
Conclusion
The process of obtaining consent and assent represents a critical yet often overlooked aspect to care of pediatric neurosurgical patients. The pediatric neurosurgeon must be able to distill immensely complex and high-risk procedures into simple, understandable terms. Furthermore, they must recognize when the child’s dissent or refusal to treatment is acceptable. In general, allowing children to be involved in their neurosurgical care is empowering and gives them both identity and agency, which is the vital first step to a successful neurosurgical intervention.

Who Are We Missing? The Impact of Requiring Parental or Guardian Consent on Research With Lesbian, Gay, Bisexual, Trans, Two-Spirit, Queer/Questioning Youth
Adolescent Health Brief
Eli Cwinn, Courtney Cadieux, Claire V. Crooks
Journal of Adolescent Health, 13 October 2020
Open Access
Abstract
Purpose
The purpose was to examine whether a requirement for parental or guardian consent systematically limits which lesbian, gay, bisexual, trans, two-spirit, queer/questioning (LGBT2Q+) youth participate in research.
Methods
A total of 60 LGBT2Q+ youth (aged 14–18 years) completed measures assessing gender and sexual minority identity, depression and anxiety, help-seeking intentions, and social support.
Results
A substantial proportion (37.6%) of youth reported that they would not have participated in the research if parental or guardian consent was required. Those who would not have participated had more negative attitudes about their sexual and gender identity, less family support, lower levels of help-seeking intentions, and higher levels of negative affect.
Conclusions
The results suggest that requiring parental or guardian consent may exclude the most at-risk youth. Policy and practice decisions regarding the health and mental health outcomes of LGBT2Q+ youth might be based on incomplete and unrepresentative data.

How acceptable is adolescent self-consent for the HPV vaccination: Findings from a qualitative study in south-west England
Suzanne Audrey, Michelle Farr, Marion Roderick, Karen Evans, Harriet Fisher
Vaccine, 9 October 2020
Open Access
Abstract
Background
Human Papillomavirus (HPV) vaccination programmes have the potential to reduce the incidence of cervical cancer. The preferred age for HPV vaccination is 12–13 years for optimal benefit. The legal framework in England allows adolescents to be vaccinated without parental consent if they are assessed as competent. A ‘South West Template Pathway on Self Consent for School Aged Immunisations’ was developed to improve uptake of immunisations in south-west England.
Study aim
To examine how acceptable the new procedures are to the young women, parents and carers, school staff and immunisation nurses involved.
Methods
The research was undertaken in two local authorities in south-west England during the 2017/18 and 2018/19 programme years. Semi-structured digitally recorded interviews were undertaken with 53 participants: one health service manager, three immunisation nurses, five staff at alternative education providers, three staff at mainstream schools, 19 young women and 22 parents. All recordings were transcribed verbatim and thematic analysis was undertaken, assisted by NVivo software.
Results
Most participants were not fully aware of the legal framework that enables a young person to self-consent to vaccination. There was a strong presumption that parents should make decisions affecting the health of their children. The preferred age at which the HPV vaccination is administered (12–13 years) contributed to reluctance in endorsing self-consent which was thought to have the potential to break down trust between parents and school staff, and within families. In practice, formal self-consent was rare.
Conclusion
Unresolved issues in relation to adolescent self-consent include public and professional perceptions of young people’s rights and abilities to take responsibility for decisions affecting their health, and concerns about the impact of self-consent on relationships both within families and between professionals and the families they serve.

Adolescent Barriers to HIV Prevention Research: Are Parental Consent Requirements the Biggest Obstacle?
Original Article
Seema K. Shah, Zaynab Essack, Katherine Byron, Catherine Slack, Daniel Reirden, Heidi van Rooyen, Nathan R. Jones, David S. Wendler
Journal of Adolescent Health, 1 October 2020; 67(4) pp 495-501
Abstract
Purpose
One third of people newly living with HIV/AIDS are adolescents. Research on adolescent HIV prevention is critical owing to differences between adolescents and adults. Parental permission requirements are often considered a barrier to adolescent enrollment in research, but whether adolescents view this barrier as the most important one is unclear.
Methods
Adolescents were approached in schools in KwaZulu-Natal, South Africa, and at a sexually transmitted infection clinic at the Children’s Hospital of Aurora, Colorado. Surveys with a hypothetical vignette about participation in a pre-exposure prophylaxis trial were conducted on smartphones or tablets with 75 adolescents at each site. We calculated descriptive statistics for all variables, using 2-sample tests for equality of proportions with continuity correction. Statistical significance was calculated at p < 0.05. Multivariate analyses were also conducted.
Results
Most adolescents thought side effects (77%) and parental consent requirements (69%) were very important barriers to research participation. When asked to rank barriers, adolescents did not agree on a single barrier as most important, but the largest group of adolescents ranked parental consent requirements as most important (29.5%). Parental consent was seen as more of a barrier for adolescents in South Africa than in the United States. Concerns about being experimented on or researchers’ mandatory reporting to authorities were ranked much lower. Finally, most (71%, n = 106) adolescents said they would want to extra support from another adult if parental permission was not required.
Conclusion
Adolescents consider both parental permission requirements and side effects important barriers to their enrollment in HIV prevention research. Legal reform and better communication strategies may help address these barriers.