Understanding parents' perspectives on clinical trials
Research type
Research Study
Full title
Understanding parents’ perspectives on clinical trials in children’s heart surgery: a qualitative study
IRAS ID
213964
Contact name
Nigel Drury
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
1 years, 9 months, 31 days
Research summary
The role of parents in decision-making for whether their child participates in a clinical trial is complex, balancing the perceived risks and benefits of the intervention. This decision may be made more difficult by the complexity of the medical information and the uncertainties inherent to clinical trials, including group allocation and potential benefit from the intervention. Indeed, the diagnosis of congenital heart disease and the realisation that their infant or child requires surgery is a particularly stressful time for parents. In other conditions, the seriousness of the child’s disease, the risk of intervention and the urgency of participation in a trial have been identified as important influences on how parents experience recruitment, their sense of vulnerability and the success of communication. However, little is known about the perspectives of the parents of children undergoing heart surgery towards their participation in clinical trials and other research.
We will conduct semi-structured interviews with the parents of infants and young children who had been approached to participate in the Birmingham Remote Ischaemic Conditioning in Children (BRICC) trial, a clinical trial in cardiac surgery which has recently started at Birmingham Children’s Hospital. The topics covered in the interviews will be developed using information obtained from a focus group of parents of children who have previously undergone cardiac surgery. Interviews will be conducted with 20-30 parents, digitally recorded, transcribed & analysed using standard techniques to identify important themes founded on the parents’ unique perspectives.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
17/WM/0088
Date of REC Opinion
28 Apr 2017
REC opinion
Further Information Favourable Opinion