Ethical considerations
RECRUITMENT
In the UK, ethical approval, MHRA approval (Clinical Trial Authorisation), HRA approval and local capacity and capability assessments will be obtained prior to the start of recruitment. In Austria, CTIS ethical approval and BASG approvals (Clinical Trial Authorisation) has been obtained. The study will be conducted in accordance with the principles of GCP and comply with all legislation. This process will be managed by the BCTU trials management team in conjunction with UCL as sponsor (the sponsor played no part in the study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication). An independent DMC will ensure the safety and dignity of the study participants as well as the reliability of the results obtained. Information will be provided to parents and patients verbally and through parent and participant information sheets. The information sheets will clearly explain that participation in the trial is entirely voluntary with the option of withdrawing from the trial at any stage and that participation or non-participation will not affect the participant’s usual care which, for children who had ever been on GH would include monitoring to FH. Though all trials involving children require careful ethical consideration, we do not anticipate any specific ethical issues beyond those in randomised controlled trials within the paediatric population. There are no major concerns surrounding the withdrawal of GH in study patients with reversed I-GHD.