About the study
CONNECT was the first UK study to explore parent and practitioner perceptions and experiences of deferred consent in children’s clinical trials. The aim of CONNECT was to provide new evidence to inform how consent should be sought for children’s critical care trials. Between 2011 and 2015, 354 people took part, including 292 parents, 39, nurses, 19 doctors and 4 clinical trials unit practitioners. Surveys, interviews and focus groups were used to explore their views and experiences on approaches to consent in emergency and urgent care settings. CONNECT findings (please see the publications section) have been integrated with wider research and ethical theory to produce guidance to inform approaches to recruitment and consent in paediatric and neonatal critical care trials.
This guidance has been developed to assist the design, review, and conduct of clinical trials investigating the emergency treatment of children (under 16 years of age1) and young people (16-18 years) with life-threatening conditions.
Who is this guidance for?
The guidance is for all those who have a direct or indirect role in the funding, design, conduct and ethical review of paediatric or neonatal trials that involve critically ill children. This includes: doctors, nurses, paramedics, researchers, patient and public involvement (PPI) representatives, members of research ethics committees, funding committees, peer reviewers and Clinical Trial Unit (CTU) staff. The guidance will also be of interest to children and young people, trial sponsors, NHS Research and Development (R&D) staff, parents and other members of the public and to organisations that represent the interests of patients and the public.
CONNECT was funded by Wellcome Trust (WT095874MF) and supported by the MRC Network of Hubs for Trials Methodology Research (MR/L004933/1- R/N42).
CONNECT guidance will be reviewed and updated as further research evidence on the recruitment process and stakeholder perspectives becomes available.
To access further details or follow the CONNECT study please go to our Facebook page.
1 Where Clinical Trial Regulations apply, a child is defined as someone under the age of 16