Introduction
There is an increasing attention for participation of minors in matters that affect them in general, and more specifically to involve them in healthcare decision making.1–4 In spite of this attention, true implementation of participation in clinical practice, let alone research participation, is poor.5 Minors are often not heard, nor consulted about decisions that concern them.3 6–10 The discrepancy between the voiced awareness towards participation of minors and current practice is caused by (A) a lack of evidence-based insights guiding participation in practice,5 and (B) a lack of adequate age-adjusted information supporting healthcare decisions.11
Recent research suggests that minors from around the age of 12 are capable of being involved in decision making, but that this competence depends on facilitating situational factors.12–14 An essential situational factor is the attitude of healthcare professionals and parents or caretakers, but it is not yet clear which attitude is most facilitating and how to achieve optimal dynamics between involved adults and minors.15 16
In addition, the minor also plays an important role in these dynamics. However, studies on the role of adolescents in decision making often consult parents instead of minors, whereas parents are unreliable proxy reporters.17 Research consulting the people at stake—minors—is scarce. More evidence is needed to understand how they experience the decision-making process, to what extent they prefer to be involved and how they view their own role.4 17 18
A prerequisite for making an informed decision about clinical research participation is to understand what is at stake.11 19 Various studies demonstrate that research information material for minors is not written at a comprehensible level.20–22 In addition, verbal information supply fails as doctor–patient conversations are commonly directed at parents or caretakers, rather than addressing the minor.10 23 Without adequate information, a minor can impossibly use its full potential to participate nor to play a meaningful role in the decision-making process.9 24–28
In order to advance the involvement of minors in decisions about clinical research participation, it is vital that they are empowered by comprehensible information, and that evidence-based insights are gained to guide participation practice. In this paper, a pilot study is presented in which we provide adolescents participating in a biobank study with previously developed novel information material, and study their perspectives on the decision-making process with the use of a ‘decision assessment tool.’ Our aim in this pilot study is (1) to gain insight in the experiences of adolescents involved in the decision-making process about research participation; (2) to perform an initial examination of the feasibility of a short interview tool on decision-making perspectives, which could be used in further research on perspectives of minors; and (3) to perform an initial assessment of the novel information material in clinical practice, and compare this material to the standard material.