Testing vaccines in pediatric research subjects

Abstract

Past difficulties encountered in pediatric vaccine research have positively influenced the development of modern regulations of human subjects' research. These regulations permit pediatric research but impose special restrictions on the types of studies to which children may participate, and these restrictions have important implications for modern vaccine trials. These ethical issues pose real but surmountable concerns. Considerations also include the use of placebos, critical for trial design but an impediment to parental permission. Recent pediatric vaccine studies illustrate practical alternatives to placebos that preserve allocation concealment and blinding yet obtain parental support. Vaccine researchers must consider the role parents play, not just in giving formal permission for their children's participation, but also for their roles in active recruitment, successful retention, and data acquisition. Studies of parents' attitudes do identify consistencies among motivating forces that drive parents to participate or refuse their children's participation. These studies should influence how we design and execute pediatric vaccine trials. Finally, ethical considerations and current regulations raise certain issues concerning the remuneration of the research volunteer when that volunteer is a child. The published literature illustrates wide variation in practice. Better understanding of the restrictions in pediatric research, the use of placebos, the attitude of parents, and the concerns with remuneration can better equip the vaccine researcher in pursuing successful studies in children.

Ethics of Vaccination in Childhood—A Framework Based on the Four Principles of Biomedical Ethics

“…The principle of nonmaleficence needs to be applied also for a process of vaccine development and registration. Because this process is accompanied by uncertainties about possible adverse effects, a special attention needs to be paid in order to prevent harm to test subjects and future vaccine recipients [ 23 , 24 , 77 , 78 ]. Because children have limited capacity of understanding and may be subject to coercion, they are considered a vulnerable population [ 79 ].…”

“…Because children have limited capacity of understanding and may be subject to coercion, they are considered a vulnerable population [ 79 ]. Therefore, special attention and certain restrictions in trial design are needed in order to protect them [ 77 , 79 ]. On the other hand, children are owed optimal and novel treatment options, which makes clinical trials in the paediatric population unavoidable and essential [ 79 , 80 ].…”