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.

Consent to Trainee Involvement in Pediatric Care
Emily A. Largent
New England Journal of Medicine, 17 September 2020
Audio Interview
Interview with Dr. Michael Greene on considerations regarding the consent process for procedures performed by medical students and residents. [09:09]
Excerpt
…Consent to the involvement of students, interns, and residents in the care of children has received scant attention as compared with consent for either care or research. But there are compelling reasons for routinely obtaining children’s assent to trainee involvement…

Enrolment of children in clinical research: Understanding Ghanaian caregivers’ perspectives on consent/assent procedures, and their attitudes towards storage of biological samples for future use
Research Article
George O Adjei, Amos Laar, Jorgen AL Kurtzhals, Bamenla Q Goka
Clinical Ethics, 13 September 2020
Abstract
Child assent is recommended in addition to parental consent when enrolling children in clinical research; however, appreciation and relevance ascribed to these concepts vary in different contexts, and information on attitudes towards storage of biological samples for future research is limited, especially in developing countries. We assessed caregivers’ understanding and appreciation of consent and assent procedures, and their attitudes towards use of stored blood samples for future research prior to enrolling a child in clinical research. A total of 17 in-depth interviews were conducted with primary caregivers of children (fathers [n = 3], mothers [n = 12], and grandmothers [n = 2]) at enrolment or on the immediate follow-up date. All caregivers recalled significant amount information from the study information sheet and were able to appropriately link such information to the consent process. While all participants confirmed information received prior to blood sampling as adequate, a few noted that the purpose was not sufficiently well communicated. Caregivers felt children were cognitively vulnerable, and prone to decisions that were not necessarily in their best interest. Nearly all caregivers felt it was their right and responsibility to overrule objections from their ward’s regarding enrolment into specific study or receipt of a therapeutic procedure. There were no objections or concerns regarding use of stored biological samples for future research purposes. There is thus, a need to improve understanding of caregivers on the information provided during the informed consent process. Context-specific studies on the age of assent in specific populations are needed.

A Consent Support Resource with Benefits and Harms of Vaccination Does Not Increase Hesitancy in Parents—An Acceptability Study
Ciara McDonald, Julie Leask, Nina Chad, Margie Danchin, Judith Fethney, Lyndal Trevena
Vaccines, 2 September 2020; 8(500)
Open Access
Abstract
It is unclear whether information given about the benefits and risks of routine childhood vaccination during consent may cue parental vaccine hesitancy. Parents were surveyed before and after reading vaccine consent information at a public expo event in Sydney, Australia. We measured vaccine hesitancy with Parent Attitudes about Childhood Vaccine Short Scale (PACV-SS), informed decision-making with Informed Subscale of the Decisional Conflict Scale (DCS-IS), items from Stage of Decision Making, Positive Attitude Assessment, Vaccine Safety and Side Effect Concern, and Vaccine Communication Framework (VCF) tools. Overall, 416 parents showed no change in vaccine hesitancy (mean PACV-SS score pre = 1.97, post = 1.94; diff = −0.02 95% CI −0.10 to 0.15) but were more informed (mean DCS-IS score pre = 29.05, post = 7.41; diff = −21.63 95% CI −24.17 to −18.56), were more positive towards vaccination (pre = 43.8% post = 50.4%; diff = 6.5% 95% CI 3.0% to 10.0%), less concerned about vaccine safety (pre = 28.5%, post = 23.0%, diff = −5.6% 95% CI −2.3% to −8.8%) and side effects (pre = 37.0%, post = 29.0%, diff = −8.0% 95% CI −4.0% to −12.0%) with no change in stage of decision-making or intention to vaccinate. Providing information about the benefits and risks of routine childhood vaccination increases parents’ informed decision-making without increasing vaccine hesitancy.

Article 5: The Role of Parents in the Proxy Informed Consent Process in Medical Research involving Children
Research Article
Sheila Varadan
The International Journal of Children’s Rights 24 August 2020; 28(3) pp 521-546
Open Access
Abstract
Medical research involving child subjects has led to advances in medicine that have dramatically improved the lives, health and well-being of children. Yet, determining when and under what conditions a child should be enrolled in medical research remains an ethically vexing question in research ethics. At the crux of the issue is the free and informed consent of the child participant. A child, who is presumed legally incompetent, or lacks sufficient understanding to exercise autonomous decision-making, will not be able to express free and informed consent in the research setting. Rather than exclude all such children from medical research, a parent (or legal guardian) is designated as a proxy to consent on the child’s behalf. However, the concept of proxy informed consent and the framework for its implementation present practical and ethical challenges for researchers, particularly in navigating the relationship between proxy decision-makers and child subjects in the medical research setting. Article 5 of the uncrc may offer guidance on this point: (1) it places boundaries around how parental authority should be exercised; (2) it offers a model for parent-child decision-making that is participatory, collaborative and linked to the child’s enjoyment of rights under the uncrc; (3) it respects and supports the autonomy of child participants by recognising their evolving capacities to give informed consent. This paper concludes that greater consideration should be given to Article 5 as a complementary framework for researchers engaged in medical research involving children.

Assessing Children’s Capacity: Reconceptualising our Understanding through the UN Convention on the Rights of the Child
Research Article
Aoife Daly
The International Journal of Children’s Rights, 24 August 2020; 28(3) pp 471-499
Open Access
Abstract
This article seeks to reconceptualise approaches to assessing children’s capacity, particularly in light of Article 5 of the crc, which enshrines the principle of the evolving capacities of the child. Professionals regularly assess children’s capacity, for example when doctors treat children, or when lawyers represent child clients. They usually do this assessment intuitively however, as there is little guidance on how assessment should work in practice. Medical law in England and Wales serves as a case study to examine law and practice as well as challenges in the area. It is concluded that it may not necessarily be possible objectively to measure children’s capacity, and it may need to be done intuitively. Yet it should be done via a process which is rights-based. An approach to children’s capacity is proposed through four concepts based on the UN Convention on the Rights of the Child: Autonomy, Evidence, Support and Protection.

Challenges in obtaining consent for caesarean delivery in minors in South Africa
N C Ngene, T Bodiba
South African Journal of Obstetrics and Gynaecology, June 2020; 26(1)
Open Access
Abstract
A 16-year-old primigravida at term developed fetal compromise in the second stage of labour and had a delayed caesarean delivery (CD) because she declined the procedure after the medical manager had consented on her behalf following the unavailability of her parents. The baby that was delivered suffered neonatal encephalopathy. This report provides a recommendation on how to improve the process of obtaining consent for CD in minors in South Africa.