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 »
Ireland’s National Research Ethics Committee for COVID-19-related health research (NREC COVID-19) is pleased to endorse the Manifesto for EU COVID-19 Research. The Manifesto emphasises the imperative to make scientific results publicly accessible without delay and encourages, where possible and for a limited time, non-exclusive royalty free licences on the intellectual property resulting from EU-funded research.
NREC COVID-19 endorses the Manifesto for EU COVID-19 Research Read More »
The Irish experience of establishing a national approach to research ethics during a global pandemic is described in a publication from the National Office for Research Ethics Committees and Prof. Mary Horgan, Chair of NREC COVID-19. This Open Letter published in HRB Open Research (https://hrbopenresearch.org/articles/3-63/v1) is currently under peer-review and open for commentary. Established by
The National Office for Research Ethics Committees publishes peer-reviewed paper Read More »