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The Minister for Health, Stephen Donnelly TD, today made significant amendments to the Health Research Regulation 2018. Those Regulations provide the legal framework that governs the collection, use and sharing of an individual’s personal information for health research purposes.  

The amendments deal with the following main areas: pre-screening to establish suitability or eligibility for inclusion in health research; carrying out low risk retrospective chart reviews; deferred consent in exceptional medical situations and new rules on consent generally. 

The Minister said: “Ultimately, the success of health research in Ireland as in any country is dependent upon public support for research.  Any person using our health services rightly feels that his or her medical information is respected and safeguarded.  That is why the purpose of the amendments is to facilitate health research and at the same time enhance public confidence in such research by protecting the rights of individuals in relation to the use of their personal health information”. 

The Minister added: “The value of health research has never been more apparent than in the race to find an effective vaccine for COVID-19. That research means we can all realistically look forward to a safer and better future. Ireland can be justly proud of the contribution that researchers in this country have made to the fight against the pandemic.

“Innovations in health care and treatment inevitably start out as ideas that need to be tried and tested through rigorous research. The Government for its part is committed to supporting health research through funding and developing improved research and regulatory frameworks.  All of this is designed to support domestic health research and make Ireland a more attractive location for international health research.  These amendments are an important part of that process.” 

The Department in collaboration with the HSE, Health Research Board and Health Research Consent Declaration Committee and in consultation with the Data Protection Commission has produced detailed guidance on the amendments which is available on the Department’s website: www.gov.ie/en/publication/b46c2-amendments-to-health-research-regulations/

The Minister also announced the appointment of four new members to the Health Research Consent Declaration Committee. They are:

• Dr Mary Tumelty (Lecturer in the School of Law, UCC)
• Dr Barry Lyons (Consultant in the Dept. of Anaesthesia and Critical Care Medicine at Children’s Health Ireland, Crumlin)
• Dr Cornelius Cooney (over 30 years of experience in the areas of anaesthesiology, and intensive care medicine).
• Mr John Woods, Data Protection Officer, St Patrick’s Mental Health Services.

NOTE TO EDITORS

Bios of persons proposed for appointment to Health Research Consent Declaration Committee

1. Dr Mary Tumelty is a lecturer at the School of Law, UCC. She holds an LLB and a PhD (UL), and her research interests include medical law, patient safety, and alternative dispute resolution. Mary has a strong record in interdisciplinary and empirical research. She has presented and published her research nationally and internationally. Her work has also been funded by the Irish Research Council and the National Forum for the Enhancement of Teaching and Learning in Higher Education.  In 2019, Mary was appointed to the Health and Social Care Professionals Council (CORU).
2. Dr Barry Lyons graduated in medicine from University College Dublin in 1989, has a BA in philosophy & history (DCU, 2007), and a PhD in Bioethics & Medical Jurisprudence (University of Manchester, 2011). Barry practices as a consultant in the Dept. of Anaesthesia and Critical Care Medicine at Children’s Health Ireland, Crumlin, where he is also Clinical Lead in Patient Safety, and Chair of the Research Ethics Committee. He is Director of Patient Safety at the College of Anaesthesiologists of Ireland. He is also a member of the HSE National Consent Policy Advisory Group, and the HSE Research Ethics Committee Reform Working Group.
3. Dr Cornelius (Con) Cooney has over 30 years of experience in the area of anaesthesiology, intensive care medicine, with a major focus in operative and perioperative care of patients. He worked at Tallaght University Hospital until 2012, where he was head of Department for two years. Following this time, he continued patient care in Clane General Hospital, The Hermitage Medical Centre, Blackrock Clinic, the Beacon Hospital and St. Patrick’s Hospital. During his time in the US, Con lectured at Harvard University and worked at the Shriners Hospital for Children and the Brigham and Women’s Hospital Boston.
4. Mr John Woods is the Data Protection Officer at St Patrick’s Mental Health Services. John has had an extensive career in information systems and data protection. He has a degree in Business with Information Systems Management from the Institute of Public Administration and an MSc in Information Technology Management from the Institute of Technology, Tallaght.  John also sits on the Hospital’s Health Research Ethics Committee and is a member of the Information Governance Framework Hospital Committee.