Optimising informed consent in school-based adolescent vaccination programmes in England: A multiple methods analysis
Tracey Chantler, Louise Letley, Pauline Paterson, Joanne Yarwood, Vanessa Saliba, Sandra Mounier-Jack
Vaccine, 24 July 2019
Open Access
Abstract
The process of obtaining informed consent for school-based adolescent immunisation provides an opportunity to engage families. However, the fact that parental consent needs to be obtained remotely adds complexity to the process and can have a detrimental effect on vaccine uptake. We conducted a multiple methods analysis to examine the practice of obtaining informed consent in adolescent immunisation programmes. This involved a thematic analysis of consent related data from 39 interviews with immunisation managers and providers collected as part of a 2017 service evaluation of the English adolescent girls’ HPV vaccine programme and a descriptive statistical analysis of data from questions related to consent included in a 2017 survey of parents’ and adolescents’ attitudes to adolescent vaccination. The findings indicated that the non-return of consent forms was a significant logistical challenge for immunisation teams, and some were piloting opt-out consent mechanisms, increasing the proportion of adolescents consenting for their own immunisations, and introducing electronic consent. Communicating vaccine related information to parents and schools and managing uncertainties about obtaining adolescent self-consent for vaccination were the main practical challenges encountered. Survey data showed that parents and adolescents generally agreed on vaccine decisions although only 32% of parents discussed vaccination with their teenager. Parental awareness about the option for adolescents to self-consent for vaccination was limited and adolescents favoured leaving the decision-making to parents. From the interviews and variability of consent forms it was evident that health professionals were not always clear about the best way to manage the consent process. Some were also unfamiliar with self-consent processes and lacked confidence in assessing for ‘Gillick competency’. Developing pathways and related interventions to improve the logistics and practice of consent in school-based adolescent immunisation programmes could help improve uptake.

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?
Perspective
Ross D. Silverman, Douglas J. Opel, Saad B. Omer
New England Journal of Medicine, 11 July 2019; 381(2)
Excerpt
…Such cases raise the question of whether adolescent minors should be able to consent to vaccinations without parental permission. For minors to be able to choose to be vaccinated over parental objections, most states would need to make substantive changes to laws governing medical consent. Since children are generally considered nonautonomous under U.S. law, treatment of a child in a medical setting requires parental permission, typically until a child reaches 18 years of age. Parents are generally given broad discretion in making decisions on behalf of their children, in part because they know their child best, are positioned to weigh competing family interests, and are permitted to raise their child as they choose. Such discretion doesn’t mean that adolescents have no role in decisions that affect them, however. Out of respect for adolescents’ developing autonomy, clinicians routinely explore their understanding of health-related issues, solicit their agreement on care plans, navigate discordance between parental and adolescent preferences, and protect adolescents’ confidentiality interests.

Both ethical principles and state laws also support independent decision making by adolescents in cases in which failing to grant adolescents autonomy could foreseeably result in substantial risk to the minor or to public health. For instance, all states have laws permitting minors to make independent, confidential clinical decisions regarding certain sensitive or stigmatized health care services, such as those related to sexual health, reproduction, mental health, and substance use disorders. Roughly 20% of jurisdictions require adolescents to be at least 12 or 14 years of age to make such decisions; others don’t designate a minimum age of consent.3 A court may also grant an older adolescent (typically 16 years or older) legal emancipation or deem the adolescent to be a “mature minor” who is able to make certain decisions independently.

Most states, however, don’t authorize adolescents to independently consent to vaccination…

Facilitating Informed Permission/Assent/Consent in Pediatric Clinical Trials
Susan M. Abdel-Rahman
Pediatric Drugs, 17 July 2019; pp 1-10
Abstract
Individuals approached to participate in human subjects research, irrespective of age, must be completely apprised of the study, and researchers must ensure that the information is understood to the fullest extent possible, prior to decision making. However, evolving regulatory and institutional requirements have led to permission/assent/consent (PAC) forms that are unnecessarily complex, serving only to exacerbate the challenges associated with communicating this important information to prospective participants. At greatest risk are children and other individuals with low literacy, limited English proficiency, and diminished mental capacity, populations all too often neglected in clinical research. This paper examines various strategies that have been evaluated to facilitate informed PAC, drawing on experiences across a broad array of populations whose needs overlap with those of children. These strategies range from simplifying PAC forms for readability and creating multimedia PAC delivery tools to actively engaging participants on their understanding of PAC elements by leveraging testing, rewards, and third-party communications. Notably, the findings from strategies that have been explored in more than one setting are uniformly mixed with respect to their ability to improve comprehension, underscoring the challenges that persist in designing, implementing, and objectively examining strategies intended to facilitate informed PAC. However, these studies do serve to highlight efforts that may reduce anxiety around, and increase the satisfaction of participants with, the PAC process. Ultimately, accommodating a diverse participant pool will require the consideration, and continual refinement, of various PAC strategies along with the engagement of team members who are intimately familiar with these populations.

Consent in paediatric neurosurgery: adequacy of documentation and parental perspectives
Adikarige H. D. Silva, Haren Wijesinghe, Nilesh Mundil, William Lo, A. Richard Walsh, Guirish A. Solanki, Desiderio Rodrigues
Child’s Nervous System, 9 July 2019; pp 1–7
Original Article
Abstract
Introduction
Consenting paediatric patients for surgical procedures remains inherently unique in that it is underpinned by principles such as parental responsibility, assessment of the child’s capacity to consent, and adherence to national/legal guidelines. Quality record keeping is an important objective evidence to demonstrate the highest standards of medical care provided to our patients. The consent form is a crucial medical record encapsulating the attainment of informed consent from a parent/guardian for performing a procedure on their child. We aimed to prospectively evaluate the consenting process in our department to assess adequacy of documentation and parental perspectives.
Methods
A prospective study using qualitative descriptive design was conducted with parents of 50 children requiring neurosurgical procedures over a 3-month period.
Results
All patients understood the primary diagnosis and type of surgery. Procedure-specific risks were understood by 98% and 84% could remember the mentioning of general risks of surgery. Only a minority of parents (24%) could recollect that alternative options of management including no treatment were discussed. In cases where relevant, laterality was only documented in 56% of consent forms. All patients felt that an informed decision regarding consent to surgery was made. However, 12% suggested areas where further improvement could be made in the timing of consent and the way information could be better provided.
Discussion
Consent is more than a signature on a form. It provides objective evidence of a shared decision-making process between the surgeon, patient, and their parent/guardian. Our initial study highlights multiple areas for improvement.