title: Why do children decide not to participate in clinical research: a quantitative and qualitative study.
abstract: BACKGROUND
  More pediatric drug trials are needed, but although specific pediatric regulations warrant safety, recruitment of children for these trials remains one of the main difficulties. Therefore, we investigated potential determining factors of nonparticipation in clinical research, in order to optimize research participation of children by recommending improved recruitment strategies.
  
  
  METHODS
  Between 1 January 2012 and 1 January 2014, we performed a prospective study among161 pediatric patients, aged 6 to 18 y, who were eligible for clinical research. We quantitatively analyzed the association of potential explanatory variables (e.g., age, cognitive development, experience, ethnicity) with nonparticipation and qualitatively analyzed interviews on reasons for nonparticipation.
  
  
  RESULTS
  Sixty percent of the children did not participate in the research project on offer (39% decided not to participate, 21% were indecisive). Lower age, less disease experience, and less complex research with lower risk were predictive for not participating. Time constraint and extra burden were expressed as decisive reasons for not participating.
  
  
  CONCLUSIONS
  Strategies to optimize research participation should be aimed at younger children and their families, who are logistically challenged and unfamiliar with health care and research. Recommendations include informing pediatric patients and their families of the value of research; minimizing logistic burdens; and improving accessibility.
authors: Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.
authors: Irma M
authors: IM
authors: Hein
authors: Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.
authors: Pieter W
authors: PW
authors: Troost
authors: Department of Medical Ethics and Health Law, Leiden University Medical Center, Leiden, The Netherlands.
authors: Martine C
authors: MC
authors: de Vries
authors: Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein, The Netherlands.
authors: Catherijne A J
authors: CA
authors: Knibbe
authors: 1] Department of Pediatrics, Emma Children's Hospital, Academic Medical Center, Amsterdam, The Netherlands [2] Department of Pediatrics, VU University Medical Center, Amsterdam, The Netherlands.
authors: Johannes B
authors: JB
authors: van Goudoever
authors: Department of Child and Adolescent Psychiatry, Academic Medical Center, Amsterdam, The Netherlands.
authors: Ramón J L
authors: RJ
authors: Lindauer
mesh_terms: D000293:Adolescent; D000533:Altruism; D035843:Biomedical Research / Q000458:organization & administration*; D002648:Child; D002755:Choice Behavior; D003657:Decision Making; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D009426:Netherlands; D010290:Parents; D010358:Patient Participation; D018579:Patient Selection; D010372:Pediatrics / Q000379:methods; D012372:ROC Curve; D012107:Research Design; D012306:Risk; D011795:Surveys and Questionnaires