Dr Jennifer Ralph James, Head of the National Office for Research Ethics Committees, reflects on one-year in office during a global health emergency, and shares the vision for the National Office going forward. The National Office was established in March 2020 as a fundamental component of the transition to a national system of research …
Welcome to our inaugural Annual Report. It reflects a year in which the National Office for Research Ethics Committees was first established, and played a pivotal role in the national research response effort during one of the most significant and unpredictable health challenges in decades. Our response to the pandemic is testament to our …
A €6-million investment by our colleagues at the Health Research Board (HRB) in Clinical Trial Networks will create new opportunities for people on the island of Ireland to contribute to cutting-edge clinical research and help advance patient care. People with dementia, diabetes, and infectious diseases, as well as patients of paediatrics, primary care and …
Minister for Health, Stephen Donnelly has appointed the membership of Ireland’s first National Research Ethics Committees (NRECs) in the areas of Clinical Trials of Investigational Medicinal Products (NREC-CT) and Clinical Investigations of Medical Devices (NREC-MD). In total, 18 members have been appointed to each of the three NRECs – two in clinical trials and …
Members appointed to Ireland’s first NRECs for Clinical Trials and Medical Devices Read More »
In May 2021, the National Office and the Health Products Regulatory Authority (HPRA) will launch the CTR-National Collaboration Project. This jointly run project will test and appraise the national preparedness for a new piece of legislation due to be implemented at an EU-level in early 2022. This new legislation, known as the EU Clinical …
Collaboration Project between the National Office and the HPRA Read More »
Clinical Trial Regulation The way clinical trials are conducted across the European Union will undergo major changes under the Clinical Trials Regulation (CTR) – due to be applied in early 2022. The CTR will harmonise the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). This in …
The National Office for Research Ethics Committees will launch Ireland’s first National Research Ethics Committees (NRECs) in the areas of clinical trials of investigational medical products (NREC-CT) and clinical investigations of medical devices (NREC-MD) in May this year. In the 12 months since the National Office was established, our team has been working closely …
As we continue to expand our activities with the launch of three new National Research Ethics Committees (NRECs) on the horizon, we are looking to grow our National Office team. We are pleased to announce the following three open positions: Programme Manager Project Officer Financial Accountant This is an opportunity to join a highly …
The call for Expressions of Interest for Membership of the National Research Ethics Committees (NRECs) has now closed and we are no longer accepting applications under this call. There was significant interest in NREC membership and we would like to thank all those who submitted an Expression of Interest. These applications are currently under …
The introduction of the Clinical Trials Regulation will also see the introduction of the new Clinical Trial Information System (CTIS) which will act as a single entry point for submitting clinical trial information in the EU and will support the daily business processes of Member States and sponsors throughout the life cycle of a trial. …
Clinical Trial Information System (CTIS) Training & Information Sharing Read More »