By Niamh McKeever & Claire Morrissey

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Published 15 July 2021

Overview

The Minister for Health has appointed the membership of Ireland’s first National Research Ethics Committees (NRECs) in the areas of Clinical Trials of Investigational Medicinal Products (NREC-CT) and Clinical Investigations of Medical Devices (NREC-MD).

In total, 18 members have been appointed to each of three NRECs – two in clinical trials and one in medical devices. The members include eminent experts from legal, academic and medical backgrounds.

The NRECs will review applications submitted through the National Office for Research Ethics Committees, and the National Office will support the new Committees in their work. Established last year, this new office is playing a key role in the reform of the research ethics review framework in Ireland, in partnership with the Department of Health.

The committees will be responsible for reviewing the ethics underpinning research proposals in these important areas of health research, with the aim of providing single national ethics opinions that are respected nationally.

The establishment of these NRECs comes at an important juncture, as Ireland will soon be required to meet new obligations under two upcoming EU Regulations: the EU Medical Device Regulation, which came into force on 26 May 2021 and the EU Clinical Trials Regulation which will come into operation on 26 May 2022.

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