Members appointed to Ireland’s first NRECs for Clinical Trials and Medical Devices

Minister for Health, Stephen Donnelly 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 the three NRECs – two in clinical trials and one in medical devices. These 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. As such, the NRECs will play a key role in protecting the safety, dignity and well-being of health research participants in Ireland.

 

The members appointed represent a diverse range of professional backgrounds and life experience, reflecting the importance of having national decisions on the ethics underpinning health research informed by the full range of skills, experience and perspectives reflective of Irish society. The list of all members can be viewed online (for NREC-CT A, NREC-CT B and NREC-MD).

 

National Office to support NRECs’ work

 

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.

 

Commenting on the appointments, Head of the National Office, Dr Jennifer Ralph James remarks:

 

“The launch of these NRECs heralds a new chapter for Irish health research, and supporting the newly appointed members in their important work is integral to the mission of the National Office.”

 

Strengthening the Irish research ethics system

 

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 Clinical Trials Regulation and the EU Medical Device Regulation. And the new Committees are expected to deliver value for the Irish research ethics system as a whole, by streamlining the process of ethics review in the areas under their remit. By strengthening the infrastructure for health research in this way, the NRECs’ work can increase Ireland’s capability to carry out world-class research, and improve access to innovative medicines and services for Irish patients.

 

“It is a huge honour for me to chair the NREC for Medical Devices” comments Professor Barry O’Sullivan, newly appointed Chair of NREC-MD. “A national approach to research ethics will help us create an integrated and supportive environment for the community to deal with the complex ethical and regulatory issues that are coming our way. Ireland is a major research hub for areas that are covered by the upcoming European Medical Device Regulation. It’s important that we work together and create a strong research ethics culture in the relevant areas.”

 

Chair of NREC-CT A, Professor Alistair Nichol remarks on the milestone development: “Clinical trials are necessary to determine the most effective treatments for patients in Ireland. The establishment of a national research ethics committee will increase Irish patients’ ability to participate in these practise-changing trials”.

 

On the clinical trials side, Chair of NREC-CT B, Dr Cliona McGovern notes: “I look forward to leading the NREC-CT Committee B in our goal of ensuring that the interests of research participants are paramount, while maintaining momentum in the conduct of clinical trials in Ireland”.

 

Application process now open for ethics review

 

Applications for ethics reviews are now being accepted to the three new Committees. For details on how to apply, submission dates and procedures, please visit the ‘Apply’ section of the National Office website.

 

Committee meeting schedule

 

The new NRECs are set to meet on a monthly basis, kicking off this month with the first meeting for clinical trials, NREC-CT A, chaired by Professor Nichol. Details of all upcoming meetings, minutes and decisions will be made publicly available on the Committee pages of the National Office website.

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