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What motivates British parents to consent for research? A questionnaire study
Helen M Sammons1, Maria Atkinson, Imti Choonara
1Academic Division of Child Health, University of Nottingham, The Medical School, Derbyshire Children's Hospital, Uttoxeter Road Derby, DE22 3DT, UK. helen.sammons@nottingham.ac.uk
Insights
Parents primarily consent to pediatric clinical trials to advance medical knowledge for future children. Most parents felt adequately informed and would participate in future research, valuing potential benefits to their own child and society.
Area of Science:
- Pediatric Clinical Trials
- Informed Consent in Research
- Parental Decision-Making
Background:
- Informed consent is crucial in pediatric clinical trials, with parental permission required.
- Limited data exists on UK parents' views regarding infant and young child participation in clinical trials.
- Understanding parental motivations and decision factors is essential for trial recruitment.
Purpose of the Study:
- To explore parental motivations for consenting to randomized clinical trials (RCTs) in children.
- To assess parental perceptions of consent processes and trial participation.
- To identify factors influencing parental decisions for future study involvement.
Main Methods:
- A postal questionnaire was administered to parents following their child's participation in a multi-center, non-blinded RCT (PIVOT Study).
- The study involved children aged 6 months to 16 years with community-acquired pneumonia.
- Statistical analysis included Fisher's Exact Test for categorical data.
Main Results:
- A 59% response rate (136/235) was achieved for the parent questionnaires.
- Most parents recalled consenting (98%), felt adequately informed (96%), and had sufficient time (95%).
- Key motivations included future benefit to children (31%), contribution to science (27%), and benefit to their own child (18%).
Conclusions:
- The primary driver for parental consent in pediatric RCTs is the advancement of future medical knowledge.
- Parents generally perceived advantages to trial participation and did not feel coerced.
- A high percentage of parents (91%) indicated willingness to participate in similar future studies.
Background:
Informed consent is the backbone of a clinical trial. In children this is given by their parents. There have been many studies in the neonatal population but little is known about the views of the parents of infants and young children from within the United Kingdom. The objectives of this study were to assess what motivates parents to consent to a randomised clinical trial (RCT), their feelings on consent and participation and the factors that would influence their decision to take part in a future study.
Methods:
The setting was a multi-centre randomised but non-blinded equivalence trial of oral versus intravenous (IV) treatment for community acquired pneumonia in previously well children aged 6 months to 16 years in the UK (PIVOT Study). Parents were sent a postal questionnaire at the end of the study which included open and closed-ended questions. Fishers Exact Test was used to analyse associations in non parametric categorical data.
Results:
243 children were recruited into the PIVOT study. Of a possible 235, 136 questionnaires were returned (response rate 59%). Of those questionnaires returned; 98% of parents remembered consenting, 95% felt they were given enough time to make their decision and 96% felt they received enough information. Major reasons for participation were benefit to other children in the future 31%, contribution to science 27%, benefit to their own child 18%. Most parents (85%) did not feel obliged to participate. 62% felt there was an advantage to taking part and 18% felt there was a disadvantage. 91% of parents said they would take part in a similar study in the future, stating influences on their decision being benefit to their own child (91%) and benefit to all children (89%).
Conclusion:
The major motivation in parents consenting for their previously well child to participate in an RCT of therapy for an acute medical illness was to increase medical knowledge in the future. Most saw an advantage in taking part in the trial and did not feel obliged to participate.
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