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NOTE: The Public consultation period has now closed. Start date of consultation: 7 October 2024 Closing date of consultation: 25 October 2024 The National Office for Research Ethics Committees invites comments on proposed ethics application fees for 2025 for: clinical trials on medicinal products, conducted under the Clinical Trials Regulation There are no fee changes […]

The latest Annual Report provides an overview of the achievements and milestones of the National Research Ethics Committees (NRECs) and the National Office, which worked closely throughout 2023 to advance and strengthen the national research ethics system in Ireland and to drive ethical health research practices aimed at safeguarding the rights, dignity, and welfare of

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

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

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

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

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