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.
Study design 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.
Conclusion 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.
- Clinical trials
- qualitative research
- scientific research
- informed consent
- newborns and minors
- Received 4 February 2010
- Revised 29 March 2010
- Accepted 13 June 2010
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Funding The study was funded by the Medical Practice Plan and University Research Board of the American University of Beirut (Grant number DCU114170.034120).
Competing interests None.
Patient consent Obtained.
Ethics approval This study was conducted with the approval of the institutional review board of the American University of Beirut.
Provenance and peer review Not commissioned; externally peer reviewed.
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