Here at the National Office, our role is to support innovative health research while ensuring the safety, dignity and well-being of research participants are safeguarded – and we do that by contributing to the system that ensures research ethics is an integral part of how health research is carried out in Ireland. But what exactly […]
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
Restructuring the NRECs to create a sustainable model for review of clinical trials Read More »
How can researchers judge the ‘right’ course of action where different value systems are in play? Do we subconsciously see some groups as more ‘deserving’ than others when it comes to inclusion in research? And as we move towards an increasingly digital and data-driven future, do we need to take a fresh look at fundamental
Effective as of 1 January 2024, the National Office for Research Ethics Committees will no longer charge fees for applications to National Research Ethics Committees (NRECs) submitted after that date by non-commercial sponsors; that is, where the sponsor funding the study is an academic or not-for-profit organisation. All other fees will remain unchanged. This pragmatic
Update to application fees for non-commercial sponsors Read More »
As the end of the year approaches, the National Office team would like to inform our stakeholders of some important dates to bear in mind. If you are applying for approval from a National Research Ethics Committee (NREC) and you wish to have your application reviewed in January 2024, please take note of the following
The National Office for Research Ethics Committees is pleased to announce the appointment of 22 new National Research Ethics Committee (NREC) members. The new members were appointed by the Minister for Health Mr Stephen Donnelly following an expression of interest campaign which ran during August and September 2023. The NRECs for Clinical Trials (NREC-CT) have
On 31 January 2022, the new EU Clinical Trial Regulation (CTR) entered into force, replacing the previous Clinical Trial Directive (CTD). The new regulation requires that all clinical trial applications and assessments be managed through a new, unified online portal known as the Clinical Trial Information System (CTIS). Since January 2023, all new applications for clinical
EMA advice on transition of clinical trials from CTD to CTR Read More »
The National Office for Research Ethics Committees has published its Annual Report for 2022, providing an overview of a productive year for the office team and the NRECs it supports. The report demonstrates the breadth of work achieved by the National Office and NRECs, reflecting the vibrant health research landscape in Ireland. In addition to
2022 in review: National Office publishes Annual Report Read More »
As of Tuesday 31 January 2023, all applications for clinical trials in Ireland must be submitted through the one-stop online portal known as the Clinical Trials Information System (CTIS). In line with implementation of the EU Clinical Trial Regulation (CTR), this is now the mandatory system for the regulatory submission, authorisation and supervision of all
Clinical trial applications must now be submitted through CTIS Read More »
The National Irish COVID-19 Biobank (NICB) is a health research infrastructure that collects and stores biological samples and associated health data, with the aim of supporting Ireland’s research response to COVID-19. To ensure its operation is underpinned by robust ethical standards, the Department of Health has tasked the National Office for Research Ethics Committees with