Restructuring the NRECs to create a sustainable model for review of clinical trials

2024 will be the final year in which clinical trials can run under the Clinical Trial Directive (CTD). By January 2025, all ongoing trials must have transitioned to Clinical Trials Regulation (CTR). To meet the demands of this final transition phase and to ensure that Ireland is ready to fully embrace the CTR, the operational structures of the National Research Ethics Committees for Clinical Trials (NREC-CTs) have been significantly revised. The restructure of the NREC-CTs will further build capacity and enable a sustainable national research ethics system in anticpiation of growth in clinical trial activity in Ireland. 

Some of the key changes include:

  • Moving from a two-committee structure to a four-committee structure
  • Increasing the number of meetings to 40 per year
  • Appointment of new Chairpersons, Deputy Chairpersons and committee members
  • Utilising the knowledge and expertise of the National Office staff to better support the Committees.

Prof. Mary Donnelly and Prof. David Brayden have been appointed as Chairs of the newly established NREC-CT C and NREC-CT D respectively.

We are also delighted that the following NREC-CT members have accepted the additional Deputy Chairperson roles:

  • Prof. David Smith
  • Ms Caoimhe Gleeson
  • Dr Christina Skourou
  • Dr John Hayden
  • Prof. Gene Dempsey
  • Prof. Colm O’Donnell

We request that all Sponsors consider transitioning clinical trials to the CTR as soon as possible to avoid any unnecessary delays. Please see guidance from the European Commission for further information. Trials that have not commenced the transitioned process by October 2024 will likely result in delays in authorisation under the CTR in advance of the January 2025 deadline.

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