Hearing the Voices of the Children: the views of children participating in clinical research

It is the responsibility of ethics committees to estimate the risks and discomfort of research procedures, and evaluate whether these are acceptable for the children. Primarily in case of discomfort, IRBs base this evaluation on their intuition and experiences, which may not necessarily give a representative view of children’s experiences. Consequently, this can lead to the rejection of studies when discomfort is expected to be excessive, and vice versa. Preferably, the estimation of discomfort is based on group-level data of children’s discomfort during research procedures, but unfortunately, these data are scarce.

In this thesis we therefore make a start in describing children’s self-reported discomfort during research procedures. These data are an important first step in providing an empirical basis for the evaluation by ethics committees and eventually providing benchmarks for the level of discomfort that might be expected for children with a given procedure.

With input from literature, interviews with children and pediatric health care professionals, we developed a questionnaire for measuring discomfort: Children’s Discomfort during Research Procedures Questionnaire (CDRPQ). The CDRPQ was completed by >350 children undergoing buccal swabs, MRI-scans, pulmonary function tests, skin prick tests, ultrasound imaging or venipunctures.

While the focus of this thesis is on discomfort, positive experiences are addressed as well. Although it was not planned to incorporate these positive experiences at first, children were eager to talk about positive experiences and benefits. These give a more balanced picture of the overall experiences of children in research.