May 10 2021 Posted: 08:00 IST

Professor Abhay Pandit (NUI Galway) and Professor David Brayden (UCD), Scientific Director and Co-Director of CÚRAM, the SFI Research Centre for Medical Devices, have been appointed to Ireland’s first National Research Ethics Committees in the areas of Clinical Trials of Investigational Medicinal Products (NREC-CT) by Minister for Health, Stephen Donnelly.

Ireland’s first NREC was established in March 2020 as part of the national coordinated response to COVID-19. The new NRECs announced this week will address the important area of clinical trials of medicinal products for human use and clinical investigations of medical devices.

The establishments of these NRECs will create a national system for research ethics review, which will cultivate the benefits of health research for patients and the public and build a transparent and cohesive research ethics review system that strengthens the national research infrastructure.

Professor Abhay Pandit is Scientific Director of CÚRAM at NUI Galway. His research integrates material science and biological paradigms in developing solutions for chronic diseases. “I am delighted to be appointed to this critical committee and to have the opportunity to help shape the research ethics framework that will support more clinical trial work in Ireland that prioritises patient interests.” he commented.

Prof Pandit has received numerous awards and distinctions, being inducted as an International Fellow in Biomaterials Science and Engineering by the International Union of Societies for Biomaterials Science and Engineering and elected as a Fellow of the Tissue Engineering and Regenerative International Society. He was also elected to the American Institute of Medical and Biological Engineering (AIMBE) College of Fellows in recognition of his outstanding contributions to establishing a national centre which will develop transformative device-based solutions to treat global chronic diseases.  He is the first Ireland-based academic to be bestowed with these honors. He has also been an elected member on the Council for both the Tissue Engineering and Regenerative Medicine International Society and European Society for Biomaterials Society.

Professor David Brayden is Co-Director of CÚRAM and a Full Professor of Advanced Drug Delivery at the University College Dublin (UCD) School of Veterinary Medicine and a Senior Fellow of the UCD Conway Institute. He has established a critical mass of drug delivery expertise in Ireland and led the SFI Irish Drug Delivery network from 2008-2013. His major research interests are in oral, buccal, and intra-articular peptide delivery using permeation enhancers, nanotechnology, and drug-device combinations.

“I’m honoured to be appointed to the NREC, it’s a wonderful opportunity to contribute to and support Irish health research and have a role to play in ensuing that the interests Irish patients and contributors to clinical trials are protected. Ireland is a global hub for MedTech R&D and it’s vital that we have a strong clear ethical framework in place to support further growth” he said.

Prof Brayden has also received numerous awards for his work including a Distinguished Service Award from the Controlled Release Society for services to its Board of Scientific Advisors. In 2012, he was the first Irish academic to be inducted into the College of Fellows of the Controlled Release Society. In 2014, he received an award for service to research from the UCD School of Veterinary Medicine. In 2017, he became the first Irish academic to be elected as a Fellow of the American Association of Pharmaceutical Scientists and received a Lifetime Achievement Award from Marquis Who’s Who®.

In total, 18 members have been appointed to three NRECs – two in clinical trials and one in medical devices. These Committees will be responsible for reviewing the ethics underpinning research proposals in the area of health research. These committees will be tasked with providing expert ethical guidance for the research process that will protect the safety, dignity and well-being of health research and clinical trial participants in Ireland.

The remit of the NREC-CTs is to review the submission of ethics applications related to Clinical Trials of Investigational Medicinal Products (CTIMP). This includes interventional studies and low-interventional studies involving medicinal products for human use. The NREC-CTs will initially run concurrently with many local recognised RECs to review CTIMP ethics applications for a defined transition period. This approach will collectively support this important area of research and ensure a smooth transition ahead of the EU Clinical Trial Regulation.

The full announcement with details of all 18 nominees is available at https://www.nrecoffice.ie/members-appointed-to-irelands-first-nrecs-for-clinical-trials-and-medical-devices/

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