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It is widely agreed that an effective response to the coronavirus disease 2019 pandemic needs to include a vaccine that is safe and effective for minors. However, many current vaccine trials have no plans for when to enroll minors. Others have recently proposed enrolling minors as young as 12 years old. This lack of a systematic approach raises 2 concerns. Waiting too long to enroll minors could unjustly deny minors and their families the benefits of a vaccine and has the potential to delay an effective response to the pandemic by a year or longer. At the same time, enrolling minors too soon runs the risk of exposing them to excessive risks. With these concerns in mind, in the present article, we propose recommendations for when and how to enroll minors in vaccine trials for the coronavirus disease 2019.

Shared decision-making (SDM) has emerged as the preferred decision-making model in the clinician-patient relationship. Through collaboration, SDM helps to facilitate evidence-based medical decisions that are closely aligned with patient or surrogate preferences, values, and goals. How to implement SDM in clinical pediatric practice, however, remains elusive, in part because SDM in pediatrics is complicated by the involvement of parents as a special class of surrogate decision-maker. A provisional framework for the process of SDM in pediatrics was recently proposed by Opel to help facilitate its implementation. To identify aspects of the framework that require refinement, we applied it across a diverse range of clinical cases from multiple pediatric specialties. In doing so, several questions surfaced that deserve further scrutiny: (1) For which medical decisions is consideration of SDM required? (2) What is considered medically reasonable when there is variability in standard practice? (3) Can an option that is not consistent with standard practice still be medically reasonable? (4) How should public health implications be factored into SDM? (5) How should variability in preference sensitivity be approached? (6) How should the developing autonomy of adolescents be integrated into SDM?; and (7) How should SDM address parental decisional burden for emotionally charged decisions? We conduct a brief analysis of each question raised to illustrate key areas for future research.

Objective. To assess how Institutional Review Boards (IRBs) implement the assent requirement for research with children. Methods. Telephone interviews were conducted with 188 chairpersons of IRBs from a range of institutions nationwide. Respondents were queried on 4 topics: 1) which children are considered capable of assent, 2) which information investigators must provide pediatric research subjects, 3) whether IRBs favor the enrollment of children who are capable of assent, and 4) how chairpersons view payment for children’s research participation. Results. Half of IRBs have a method that they require investigators to follow when determining which children are capable of assent, most commonly an age cutoff. Half of IRBs do not have a method, and the majority rely on investigators’ clinical judgment. IRBs largely follow the adult research regulations when determining which information should be provided to an assenting child. A total of 58% of IRBs would enroll a child who is incapable of assent in a nonbeneficial study, even if children who are capable of assent could be enrolled instead. Almost half (46%) of chairpersons believe that it sometimes or always acceptable to offer incentive payments to children, and more than one third (35%) thought it acceptable to offer payment to the parents. Conclusion. When possible, IRBs follow the federal regulations for research with adults when implementing the assent requirement. For considerations that do not have analogs in the adult regulations, IRB practices vary widely. These data suggest that IRBs need guidance on how to implement the assent requirement in a way that provides appropriate protections for pediatric research subjects.