Apply to NREC-CT

New study applications under the Clinical Trials Directive (CTD) are no longer accepted by the National Office for Research Ethics Committees and must be submitted under the Clinical Trials Regulation (CTR) using the Clinical Trials Information System (CTIS).

The NREC-CT reviews applications related to Clinical Trials of Investigational Medicinal Products. This includes interventional and low-interventional studies that include medicines for human use.

Accessibility of documentation

Any documentation submitted for NREC review must be presented in an accessible and searchable format (Word or original PDF). We are unable to accept scanned documents as these documents are composed of images, rather than searchable text, and cannot be optimised for use with assistive software. If it’s not possible to submit an accessible document due to a scanned wet ink signature, an unsigned accessible version must also be included as part of the submission. Submissions that are not in an accessible format may be deemed invalid or may delay the assessment process.

Submit under the Clinical Trials Regulation

  • As of 31 January 2023, all new clinical trial applications to be submitted under the Clinical Trials Regulation.
  • All submissions and notifications related to trials that fall under the Clinical Trials Regulation must be made through the Clinical Trials Information System.
  • All trials that come under the Clinical Trials Regulation where Ireland is a Member State concerned will fall within the remit of the NREC-CTs with the support from the National Office. This includes ongoing trials that have now transitioned to the Regulation.
  • Please see the NREC Operational Framework for further information.

Submission under the Clinical Trial Directive

  • The Clinical Trials Directive was transposed into national law under the S.I. No. 190/2004.
  • New applications under the Clinical Trials Directive (CTD) are no longer accepted by the National Office for Research Ethics Committees.
  • Substantial amendments to trials authorised under the CTD are permitted until 30 January 2025.
  • All trials authorised under the CTD must end or transition to the CTR by 30 January 2025.
  • Trials that continue to fall under the CTD can transition to the NREC system through the submission of a substantial modification.
  • Trials that have not yet transitioned to the CTR or the NREC-CT through the submission of a substantial modification must continue to report to the relevant recognised local research ethics committee where they initially received approval.

Aligning your study with the Health Research Regulations

All applications submitted to the NRECs for ethics assessment must demonstrate compliance with the requirements under the Health Research Regulations 2018, as well as any other national or European legislation relevant to the study. Below are some examples of the key safeguards from the HRR 2018 that all studies must comply with:

  1. Ethics review

Any processing or further processing of personal data for the purposes of health research requires ethics approval by a research ethics committee. This includes the re-use of study data for secondary research purposes when identifiable or pseudonymised data is used.

  1. ‘Broad’ or ‘explicit’ consent for future use

The legislation allows for the use of ‘broad’ or ‘explicit’ consent in the processing or further processing of personal data for the purposes of health research. This legislation does not allow for blanket consent. Consent for future use of data must be limited to a particular disease area or more generally in that area or a related area of health research and must be clearly described in the Participant Information Leaflet. An example would be limiting future use of study data to the disease and / or medicinal product / device being studied.

  1. Consent declarations

If your study involves participants that may lack decision making capacity, or you are unable to obtain explicit consent for the personal data being processed in the study, then an application for a consent declaration may be necessary.  The NRECs must be notified if a study requires a consent declaration as part of the application. This can be included in the Cover Letter or the Recruitment and Informed Consent Procedure. It is advisable to engage with the Secretariat of the HRCDC with any queries on this as early as possible in your project, in order to prevent potential delays.  secretariat@hrcdc.ie, www.hrcdc.ie

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