title: Parental attitudes towards and perceptions of their children's participation in clinical research: a developing-country perspective.
abstract: BACKGROUND
  Paediatric clinical research faces unique challenges that compromise optimal recruitment of children into clinical trials. A main barrier to enrolment of children is parental misconceptions about the research process. In developing countries, there is a knowledge gap regarding parental perceptions of and attitudes towards their children's participation in clinical trials.
  
  
  OBJECTIVE
  To explore such perceptions and attitudes in Lebanese parents.
  
  
  METHODS
  33 in-depth interviews were conducted with parents with and without previous research experience. Interviews were tape-recorded, transcribed in colloquial Arabic, and later subjected to thematic analysis.
  
  
  RESULTS
  Benefit/risk ratio assessment was a major determinant of parental consent. Fear of adverse events or painful procedures in research was a recurring theme in most interviews. Whereas perception of direct benefit to the child, trust in the physician or institution, financial gains or having a positive previous experience in research facilitated consent, a complex informed consent form and misunderstanding of the term 'randomisation' hindered parental approval of participation.
  
  
  CONCLUSIONS
  Lebanese parents have perceptions of and attitudes towards children's participation in clinical trials that are similar to those reported from the industrialised world. Improving communication with parents and building trust between researchers and parents is important for successful recruitment. Investigators planning to conduct paediatric trials in developing countries need to simplify consent forms and devise new ways to explain randomisation.
authors: Department of Pediatrics and Adolescent Medicine, American University of Beirut Medical Center, Beirut, Lebanon. mn04@aub.edu.lb
authors: Mona
authors: M
authors: Nabulsi
authors: Yvette
authors: Y
authors: Khalil
authors: Jihad
authors: J
authors: Makhoul
mesh_terms: D000293:Adolescent; D001294:Attitude to Health; D002648:Child; D002675:Child, Preschool; D003906:Developing Countries; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007861:Lebanon; D010287:Parent-Child Relations; D010290:Parents / Q000523:psychology*; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D012107:Research Design / Q000592:standards*; D035842:Research Subjects / Q000523:psychology*; D018570:Risk Assessment; D055815:Young Adult