Article Text
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.
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
- perceptions
- attitudes
- qualitative research
- scientific research
- informed consent
- newborns and minors
Statistics from Altmetric.com
Read the full text or download the PDF:
Other content recommended for you
- Understanding parents’ decision-making on participation in clinical trials in children’s heart surgery: a qualitative study
- Return of participant-level clinical trial results to participants: pilot of a simplified centralised approach
- Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study
- Children’s views on research without prior consent in emergency situations: a UK qualitative study
- How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study
- Perspectives of adult offspring of participants recruited to a randomised trial in pregnancy: a qualitative study
- Split views among parents regarding children’s right to decide about participation in research: a questionnaire survey
- Phase I oncology trials: why the therapeutic misconception will not go away
- Why do parents enrol their children in research: a narrative synthesis
- Assent for children's participation in research is incoherent and wrong