Clinical Trials

The remit of the National Research Ethics Committees for Clinical Trials (NREC-CTs) is to provide ethical reviews of applications to conduct Clinical Trials of Investigational Medicinal Products (CTIMPs). This includes interventional studies and low-interventional studies involving medicinal products for human use.

The National Research Ethics Committees for Clinical Trials are recognised by the Department of Health under S.I. No. 41/2022, the European Union (Clinical Trials on Medicinal Products For Human Use) (National Research Ethics Committees) Regulations 2022. Members of the committees are appointed by the Minister for Health.

For further information related to the NREC-CTs, please contact the National Office at clinicaltrials@nrec.ie or visit the website at https://www.nrecoffice.ie/

If you plan to submit a CTIMP application for ethics review, please visit Apply NREC-CT.

If you are interested in the underlying processes and management of the NREC-CT, please download the Operational Framework.

Details of all upcoming meetings, minutes and decisions are published on the NREC website along with a full list of committee members.

New European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. The Regulation aims to ensure that the EU offers an attractive and favourable environment for carrying out clinical trials of medicines on a large scale, with high standards of public transparency, and safety for clinical trial participants.

On 31 January 2022, the EU Regulation repealed the Clinical Trials Directive (EC) No. 2001/20/EC, which regulated clinical trials in the EU until the Regulation's entry into application. However, a defined transition period still applies to clinical trials submitted under the Directive.

The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU and has been transposed into national legislation through S.I. No. 41/2022 and S.I. No. 99/2022 – the European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022.

The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries.

Prior to 31 January 2022, clinical trial sponsors had to submit applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The new Regulation enables sponsors to submit one application via a single online platform known as the Clinical Trials Information System (CTIS) for approval to run a clinical trial in several European countries.

The Regulation also makes it more efficient for EU Member States to evaluate and authorise such applications together, while communicating via the Clinical Trials Information System. The purpose is to foster innovation and research in the EU, facilitating the conduct of larger clinical trials in multiple EU Member States/EEA countries.

Other key benefits of the Regulation include:

• improved information-sharing and collective decision-making on clinical trials;

• increased transparency of information on clinical trials;

• high standards of safety for all participants in EU clinical trials.

Under the Clinical Trials Regulation, national regulators in the EU Member States and EEA countries will use CTIS to carry out their legal responsibilities in evaluating and overseeing clinical trials from 31 January 2022. However:

• until 30 January 2023, clinical trial sponsors may use CTIS to apply to run a clinical trial under the Clinical Trials Regulation or may choose to apply to run a trial under the Clinical Trials Directive;

• from 31 January 2025, any trials approved under the Clinical Trials Directive that continue running will need to comply fully with the Clinical Trials Regulation.

The European Medicines Agency has encouraged trial sponsors to use the transition period to ensure that information on their clinical trials is recorded in CTIS in a timely manner.

For more information on regulatory aspects, please visit the HPRA clinical trials webpage here.

The following Ethics Committees have been recognised under Regulation 7 of the above regulations to act for the whole State.

These committees are also recognised to provide ethical approval for clinical trials of investigational medicinal products which fall within the scope of the Ionising Radiation Regulations (SI No. 256 of 2018).