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Hearing the voices of children: self-reported information on children's experiences during research procedures: a
Mira S Staphorst1, Joke A M Hunfeld1, Reinier Timman1
1Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, Rotterdam, The Netherlands.
Insights
This study protocol outlines a two-phase approach to understand children's experiences in clinical research. Findings will inform ethical review and improve pediatric research practices.
Area of Science:
- Pediatric Clinical Research
- Child Psychology
- Research Ethics
Background:
- Balancing the needs of pediatric research with child welfare is challenging due to limited data on children's perspectives.
- Empirical data on children's self-reported experiences during research procedures are scarce.
- This study addresses the need for understanding children's lived experiences in research settings.
Purpose of the Study:
- To develop and validate a questionnaire measuring children's experiences during research procedures.
- To gather empirical data on children's self-reported experiences from their own perspective.
- To inform ethical review processes and improve the design of pediatric clinical trials.
Main Methods:
- A two-phase study involving qualitative interviews with children (6-18 years) followed by quantitative questionnaire development.
- Interviews with approximately 40 children will inform questionnaire design.
- The developed questionnaire will assess experiences across seven research procedures, with a one-month follow-up for emotional impact.
Main Results:
- The study protocol is described for a two-phase investigation.
- Interviews will guide the creation of a quantitative instrument.
- The questionnaire will be used to measure children's experiences in various research procedures.
Conclusions:
- This research aims to provide crucial data on children's experiences in clinical research.
- Findings will assist Institutional Review Boards and researchers in evaluating and designing pediatric studies.
- Informed decision-making for children and parents regarding research participation will be facilitated.
Introduction:
In paediatric research, there is a tension between what you can ask from a child and what is needed for the development of evidence-based treatments. To find an optimal balance in conducting clinical research and protecting the child, it is necessary to have empirical data on children's experiences. Until now, there are scarce empirical data on the experiences from the perspective of the child. In this manuscript, we describe the protocol of a two-phase study measuring children's self-reported experiences during research procedures.
Methods And Analysis:
In the first phase of our study, we aim to interview approximately 40 children (6-18 years) about their self-reported experiences during research procedures. In the second phase, we will develop a questionnaire to measure children's experiences during research procedures in a quantitative way. We will use the interview outcomes for the development of this questionnaire. Next, we will measure the experiences of children during seven research procedures with this questionnaire. A one-month follow-up is conducted to investigate the emotional impact of the research procedures on the children. Children will be recruited from different research studies in three academic children's hospitals in the Netherlands.
Ethics And Dissemination:
The ethics committee of the VU University medical center evaluated both studies and indicated that there was no risk/discomfort associated, stating that both phases are exempt from getting approval under the Dutch Law. Dissemination of results will occur by conference presentations and peer-reviewed publications. The findings of our project can help Institutional Review Boards and paediatric researchers when evaluating the discomforts of research procedures described in study protocols or when designing a study. Information on experiences of children involved in previous studies may also help children and parents in future research with their decision-making about participation in clinical research, or parts thereof.
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