WP05 - Study monitoring and ethics

 

Workpackage lead and partners:

WP leader:
Prof. Tony Ryan, UCC

WP partners:
CHU

Workpackage objectives: 

  • Setting up an ethics advisory board (EAB) for the study
  • Ensuring that the safety of the newborn infant (both short-term and long-term) is always the main priority of the study
  • Review of all local ethical approval documentation from all participating centres
  • Ensuring that the clinical trial design conforms to ICH-GCP guidelines

Workpackage description:

The goal of this work package will be to supervise the ethics and safety of the clinical trial. This will be carried out through the establishment of an ethics advisory board (EAB) and a data and safety monitoring board (DSMB). The tasks are set out below.

Task 1: Establishment of the ethics advisory board (EAB)

This board will consist of a Chair, Dr Deirdre Madden, University College Cork. The other members of the board will consist of Dr Keelin O Donoghue, an obstetrician with a special interest in Perinatal Medicine, Professor David Smith, an ethicist with RSCI, and Daniel Nuseum, a parent representative.

Task 2: Establishment of the data and safety monitoring board (DSMB)

An independent data and safety monitoring board (DSMB) will be established which will be fully independent from the participant centres and all applicants. Professor Henry Halliday will chair the DSMB, Dr Al Ozonoff is the biostatistician and Professor Jean-Christophe Mercier is experienced in neonatal trials.  

Task 3: Review of clinical trial protocol.

The clinical trial protocol will be reviewed and all ethical concerns will be reported directly to the study coordinator and sponsors (P1, P8). 

Task 4: Review parent information sheet and consent form

Forms will be adapted for local participating centres listing items such as local investigator names and contact information. All forms will be translated in the native country language but every attempt will be made to keep all information uniform across the participating centres.

Task 5: Ensure compliance with all ethical and regulatory guidelines

To ensure compliance with ICH-GCP requirements and European laws regulating the conduct of clinical trial.