title: Hearing the voices of children: self-reported information on children's experiences during research procedures: a study protocol.
abstract: BACKGROUND
  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
  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.
  
  
  BACKGROUND
  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.
authors.affiliation: Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Mira S
authors.initials: MS
authors.lastname: Staphorst
authors.affiliation: Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Joke A M
authors.initials: JA
authors.lastname: Hunfeld
authors.affiliation: Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Reinier
authors.initials: R
authors.lastname: Timman
authors.affiliation: Department of Clinical Psychology/EMGO+, VU University, Amsterdam, The Netherlands.
authors.forename: Jan
authors.initials: J
authors.lastname: Passchier
authors.affiliation: Department of Pediatrics, VU University Medical Center (VUmc), Amsterdam, The Netherlands Department of Pediatrics, Academic Medical Center (AMC), Amsterdam, The Netherlands.
authors.forename: Johannes B
authors.identifier: http://orcid.org/0000-0003-3960-1703
authors.initials: JB
authors.lastname: van Goudoever
mesh_terms: D000293:Adolescent; D001007:Anxiety / Q000523:psychology*; D035843:Biomedical Research / Q000379:methods*; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D009426:Netherlands; D011569:Psychiatric Status Rating Scales; D012107:Research Design; D057566:Self Report; D013315:Stress, Psychological
keywords: ETHICS (see Medical Ethics); MEDICAL ETHICS; PAEDIATRICS; QUALITATIVE RESEARCH