health research ethics ireland

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National Office for Research Ethics Committees

The National Office for Research Ethics Committees is an important component of the research environment in Ireland. Our mission is to continue to embed a robust, transparent and cohesive research ethics review system that strengthens the national research infrastructure. We establish National Research Ethics Committees (NRECs) in prescribed areas of health research at the request of the Minister for Health. An essential aspect of the NREC system is the mandate to return ethics decisions that are respected nationally (‘single national ethics opinion’). Working alongside local research ethics committees and supported by the National Office team, the NRECs work in a mixed-model system to support research ethics across the spectrum of health research in Ireland.

The National Office was established in early 2020 as an important component of the reform of the research ethics committee framework in Ireland led by the Department of Health. In partnership with the other regulators of health research, we are implementing a roadmap of transition to a national system of research ethics review for regulated remits, including clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices. We are working closely with local research ethics committees to ensure this transition is as seamless as possible for researchers and research-performing organisations. As a major change to the research environment, this transition requires shared coordination, cooperation and momentum.

Role of the National Office

As an independent office with a statutory function, our role at the National Office for Research Ethics Committees includes the following:

• Establishing NRECs in specific areas of health research
• Managing Expressions of Interest for NREC membership
• Providing operational support to NRECs
• Monitoring and oversight of NRECs
• Issuing guidelines for NREC work
• Education and outreach
• Initial priority areas

The National Office launched the first NREC in March 2020 as part of the national coordinated response to COVID-19. While NRECs will be established in a variety of health research areas over time, the initial priorities of national strategic importance were clinical trials of medicinal products for human use, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices, to ensure Ireland is meeting the obligations as an EU Member State in line with EU Regulations on clinical trials (Regulation EU 536/2014),medical devices (Regulation EU 2017/745) and in vitro diagnostic medical devices (Regulation EU 2017/746). In addition, this ensured Ireland is an attractive place to conduct research in these important areas and maximise the opportunity for Irish patients to participate in forefront research, gaining access to innovative medicines and services. In 2022 the remit of NREC expanded further and now also includes the ethical review of performance studies of in vitro diagnostic medical devices in line with EU regulation on in vitro diagnostic medical devices (Regulation EU 2017/746).

Read more about the NRECs:

• NREC COVID-19

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Research Ethics in Ireland: How do we strengthen and harmonise the system?

HRCI was delighted to host an Irish Health Research Forum event focusing on the research ethics system in Ireland. 

There are many good people working hard to ensure that the highest standards in research ethics are maintained in Ireland. This is often done under difficult circumstances, and many contribute in a purely voluntary capacity. Despite the huge efforts by everyone involved, the systems are fragmented and under-resourced. This results in delayed research which hampers the potential of health and social care research to make a real difference in people’s lives.

The purpose of this event was to consider the current strengths and weakness of the system and to make constructive recommendations. Over 80 people attended and key decision makers in the room included representatives from the HSE, the National Research Ethics Committees, the Department of Health, the Data Protection Commission, HPRA and the HRB. Very importantly the HRCI member charities, patient representatives, researchers and people from industry were strongly represented and had their voices heard. Following robust discussion on the day and guided by the exceptional Irish Health Research Forum Steering Group, we are delighted to produce 7 recommendations to improve the research ethics system in Ireland.

PDF and Word versions of the Report are available through the links below

If you have any difficulty in accessing the report, please contact Linda McGrath, HRCI Events & Communications Coordinator [email protected] 

Legislation

Secretariat.

• Annual report
• Amendments to the Health Research Regulations
• Frequently Asked Questions
• The Consent Declaration Process
• Presentations
• Decision Flow Chart
• Meeting Dates 2024
• Application Process
• Application Forms
• Amendment to a Consent Declaration
• HRCDC Meeting Minutes
• HRCDC Decisions
• Standard Conditions of a Declaration
• Minutes & Decisions
• Appeal Process
• Annual Report

The Health Research Consent Declaration Committee (HRCDC) was established as part of the Health Research Regulations made under the Data Protection Act, 2018.

The purpose of those Regulations is to support health research and promote necessary and desirable public confidence in such research.

The Regulations make explicit consent the default position for processing personal data for health research. In other words, a health researcher planning to use an individual’s information for health research must obtain the explicit consent of the individual to do so. This is about empowering the patient in relation to his or her medical records.

However, it is recognised – as it is in other countries – that sometimes, in limited situations, obtaining consent will not be possible and that the public interest of doing the research significantly outweighs the need for explicit consent. It is in cases like this that HRCDC has a decision making role.

The Regulations provide for a statutory consent declaration process. That enables a data controller carrying out health research using personal data, to apply for a consent declaration which means that the consent of the individual is not required for the obtaining and use of his or her personal information for the health research concerned.

In order that such applications are carefully considered from a range of perspectives, the Health Research Regulations provide for an independent and representative committee to make decisions on those applications – that is the role of the HRCDC.

In everything that we do, our objective will be to seek to build Transparency, Confidence and Trust.

The Standard Operating Procedures for the Secretariat and HRCDC can be accessed using the link below:

HRCDC Standard Operating Procedures

Regarding explicit consent, the Health Research Regulations 2018 maintain the existing situation in law, where explicit consent is the default position for all processing and further processing of personal data for health research purposes (unless the personal data is wholly anonymised or there is specific legal provision authorising the health research in question).

The Health Research Regulations 2018 provide for a 1 year period of transition (Amendment No. 1 – S.I.188) to allow for current health research projects that commenced on or before 7 August 2018, to reach the consent standard laid down by the GDPR or else to obtain a consent declaration where it can be demonstrated that this consent standard cannot be achieved.

It is important that health researchers engage fully with their Data Protection Officers to understand the law in this area as it affects the processing of personal data for health research in Ireland.

Committee Members

Ms. brigid mcmanus.

Chairperson

Brigid McManus is a former Secretary – General of the Department of Education and Skills with extensive senior management experience in the Departments of Education, Finance, and Arts, Culture and the Gaeltacht. During this time and in more recent non-executive roles she has worked on a wide range of economic and social public policy issues involving diverse stakeholders. Currently she is a Board member of Children’s Health Ireland and a member of the Board of Governors of the National College of Ireland.

Emeritus Professor Evelyn Mahon

Deputy Chairperson

Prof. Evelyn Mahon (M.Sc., London School of Economics; Ph.D. University of London), Fellow Emeritus of Trinity College, Dublin, retired as an Associate Professor in the School of Social Work and Social Policy. A sociologist, she successfully led a number of funded research projects on sensitive health and social research issues. These included Women and Crisis Pregnancy (1998), Post-Separation Parenting (2011), and Assisted Reproductive Technology – IVF Treatment in Ireland (2014). Recognising the importance of empirical research in policy formation, and the need to develop research capabilities, she founded and directed the master’s programme (M.Sc.) in Applied Social Research at Trinity College, in 1997. Directing the M.Ss. as well as the dissertations of her Ph.D. students led her to establish and chair the first Research Ethics Committee in the School. She has served on several committees including the Epidemiology, Heath of the Population and Primary Care Committee of the Health Research Board.

Dr. Aideen Hartney

Dr Aideen Hartney has almost 20 years experience in conducting or managing research for the public good and is now the Director of the National Disability Authority (NDA). The NDA is a statutory body with a role to provide evidence-informed policy advice to government on matters concerning disability. The NDA conducts and commissions research on a range of subjects, including provision and evaluation of health and social care supports and services for persons with disabilities. This can include conducting research with individuals with disabilities, including those who may have complex or profound disabilities. The NDA is committed to ensuring that their experiences and perspectives are included in research in a manner that is compliant with all relevant legislation. Aideen will bring this valuable perspective, as well as her broader knowledge of the funded research landscape, to the deliberations of the Health Research Consent Declaration Committee.

Ms. Alyson Bailey

Alyson Bailey qualified as an Interior Designer, but her career was punctuated by many years of being a stay-at-home mum and carer. Alyson returned to full-time education graduating from UCD in 2008 with a double first in English & Philosophy, and in 2009 with a MA (first) in Anglo-Irish Literature & Drama. As a mother, daughter, patient and carer, she has extensive experience of a wide range of hospital and community services. She has participated on the Health Research Board Public Review Panel since its inception, and has provided input to the review of research grant applications from a pubic representative perspective. Alyson has attended both HRB Patient & Public Involvement (PPI) workshops and in 2018 acted as a peer mentor sharing her experience with future public reviewers. In 2019 she was a guest speaker at the DCU PPI Ignite seminar where she spoke on the topic of PPI in grant applications.

Ms. Kathy Brickell

Kathy Brickell is the Lead Intensive Care Unit Research Coordinator at St Vincent’s University Hospital. She qualified as registered nurse from St Vincent’s Hospital and completed her ICU training in the Mater Misericordiae University Hospital. She has over 30 years’ experience in nursing including over 15 years of ICU experience and 4 years of retrieval medicine. In her current role she coordinates and runs clinical research projects and trials in the ICU. She actively participates and supports the work of the Irish Critical Care Clinical Trials Groups (ICC-CTG), a collaboration involving three quarters of the Irish intensive care units. The ICC-CTG brings together doctors, nurses and researchers to test new treatments that can improve outcomes for these patients.

Dr. Sheelah Connolly

Sheelah Connolly is a senior research officer at the Economic and Social Research Institute (ESRI). Sheelah brings to the committee extensive training and experience in applied health research in Ireland and the United Kingdom. For the past 15 years, Sheelah has contributed to and led on a variety of research projects in a number of areas including the social and economic determinants of health, the economics of ageing, neurodegenerative disorders and health services reform. This research has involved the use of a variety of data types including survey data, administrative data and patient health records. Through her research, Sheelah has become very familiar with issues around research ethics, data protection, patient consent.

Dr. Simon Furney

Dr Simon Furney is a Research Lecturer in Genomic Medicine and Principal Investigator of the Genomic Oncology Research Group at the Royal College of Surgeons in Ireland. My background is in bioinformatics and biomedical genomics, primarily in cancer but has also worked in Alzheimer’s disease in the past. Simon’s expertise is in the analysis of genomic data from patients to try to identify disease-causing mutations. He have analysed thousands of genomes from patients using genotyping arrays and next generation sequencing technologies including whole genome and whole exome sequencing. Simon is a member of the Global Alliance for Genomics and Health (https://www.ga4gh.org/), the Genomics England Clinical Interpretation Partnership (GeCIP; https://www.genomicsengland.co.uk/about-gecip/) and the Irish Centre for High End Computing Science Council (ICHEC; https://www.ichec.ie/).

Dr. Zubair Kabir

Zubair trained both in public health medicine and epidemiology, is actively involved in applied public health research involving large secondary datasets both locally and internationally. His expertise in Tobacco Control research and in population health epidemiological modelling studies are policy-related. He chairs the School of Public Health Ethics Committee in University College Cork (UCC). He is also the Course Director of the Master of Public Health (MPH) Program in UCC whereby he oversees students’ research ethics applications and Dissertations. He is the lead researcher from Ireland on the high-profile Global Burden of Disease (GBD) Study, and has published widely in the Lancet. He sits on the UCC Social Research Ethics Committee (SREC) reviewing social research ethics applications university-wide. Dr Kabir is a Senior Lecturer at the School of Public Health, UCC since 2012 (https://research.ucc.ie/profiles/C010/zkabir). He also holds a Research Associate position at the TobaccoFree Research Institute Ireland (https://www.tri.ie/personnel.html).

Mr. Dan Rea

Dan Rea brings almost four decades of experience from high tech manufacturing within the private sector. He has worked with various organizations across Europe, The USA and Asia, and has gained large and varied experience in Management roles incorporating production, product research and development, resource optimization and systems. He retired from his role as Manufacturing Operation Manager in 2014, to pursue personal business interests. He has served as a council member and officer for a number of years on An Comairle na Mumhan, which is the Munster council affiliated to An Coimisiún le Rincí Gaelacha.In recent years Dan has been involved in patient advocacy, particularly with those on journeys through Cancer and Mental Health. His other interests include biodiversity, climate change and environmental conservation.

Dr. Cornelius Cooney

Cornelius 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.

He graduated with a B.Sc. and M.Sc. from University College Cork (UCC), obtained a Ph.D. from the University of Minnesota and completed his Post-Doctoral research fellowship in UCC.

After graduating from Medicine at UCC in 1982, he held a number of Senior House Officer/Registrar positions at the Cork University Hospital, followed by anaesthesia training. He completed an advanced Clinical Fellowship at Massachusetts General Hospital. He lectured at Harvard University. He worked at the Shriners Hospital for Children and the Brigham and Women’s Hospital Boston.

Cornelius, now retired from clinical practice, has is a fellow of The College of Anaesthetists of Ireland and remains a life member of the American Society of Anaesthesiology and is registered with the Irish Medical Council.

Dr. Barry Lyons

Dr. Barry Lyons graduated in medicine from University College Dublin in 1989, has a BA in philosophy & history (2007), and a PhD in Bioethics & Medical Jurisprudence (University of Manchester, 2011). He practices as a consultant in the Department of Anaesthesia and Critical Care Medicine at Children’s Health Ireland, Crumlin, where he is Clinical Lead in Patient Safety, and Chair of the Research Ethics Committee. He is also Director of Patient Safety at the College of Anaesthesiologists of Ireland. He is involved in a number of advisory groups examining consent in clinical and research practice and is a member the HSE Research Ethics Committee Reform Working Group. His research interests relate to the role of negative emotions in medicine and, more generally, the interface between law and medicine.

Dr. Mary Tumelty

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) by the Minister for Health. She is an external examiner for the Health Law and Ethics LLM at Nottingham Trent University, and a member of the Management Committee for EU COST Action “The European Researchers’ Network Working on Second Victims”.

Mr. John Woods

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. John 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 holds CIPP/E and CIPM certifications.

John’s areas of interest include data protection, privacy by design, and information governance. John sits on the Hospital’s Health Research Ethics Committee and is a member of the Information Governance Framework Hospital Committee. John served on the first National Research Ethics Committee (NREC) that was established by the Minister of Health to deliver an expedited process for review of COVID-19-related health research.

Ms. Patricia O’Beirne

Patricia O’Beirne has a primary degree in engineering and has worked in two medical device companies in Galway, namely Medtronic and most recently Aerogen (2019-2022), in both R&D and manufacturing. Patricia also attended the University of Galway, initially part-time, where she undertook a Diploma in English Literature, and then full-time to complete a Masters in Theatre and Drama and in 2019 was awarded a PhD (Doctoral Thesis in Arts and Humanities) from the university of Galway. Recently Patricia has begun working as a postdoctoral researcher on an IRC funded project examining the economics of working as a theatre practitioner in Ireland over the last two decades.

Patricia has personal experience with caring for a family member, of parenting, and of advocating for family members in the health system. Patricia has been involved with the Health Research Board (HRB) Public Review Panel since 2017, reviewing research grant applications from a wide variety of disciplines in her role as a public reviewer and providing feedback to the HRB from a Patient & Public Involvement (PPI) perspective.

Prof. Susan Smith

Susan Smith is Professor of General Practice at Trinity College Dublin and works as a General Practitioner at Inchicore Family Doctors in Dublin 8. Her research interests include improving outcomes for patients with multimorbidity and related clinical issues such as medicines management, including access to medicines.

She has been the PI or Co-PI on eight randomised controlled trials of interventions for chronic disease management in Irish primary care settings and is associate Director of the HRB Primary Care Clinical Trials Network in Ireland. She is an editor and author with the Cochrane Collaboration and is an advocate for Evidence Based Medicine and Shared Decision Making. She has extensive experience in Evidence Synthesis and is Clinical Lead for the HRB Collaboration in Ireland for Clinical Effectiveness Reviews and she is a member of the HIQA COVID19 Expert Advisory Group, which provides evidence based reviews to inform public policy and guidance.

She also has an interest in health equity and coordinates the Deep End Ireland Group, which advocates for appropriate primary care services for socioeconomically disadvantaged groups.

Prof. Paul Stynes

Prof. Paul Stynes (M. Eng University of Limerick; PhD in Artificial Intelligence, Trinity College Dublin), Dean of the School of Computing at the National College of Ireland. An experienced academic leader with a history of working in both higher education and industry. Skilled in leading educational programme development, research, knowledge transfer and international collaborations. A highly motivated, action and process-oriented individual with a strong track record of attracting Government funding and is the principal investigator for the Science Foundation Ireland-funded STEM Family Learning Programme. Demonstrated research and scholarship with over 43 scientific publications in Artificial Intelligence/Machine Learning and Educational Management. Research in the medical domain relates to the use of Machine Learning to classify the brain age from MRI images.

The Committee

The Health Research Consent Declaration Committee (HRCDC) is appointed by and reports to the Minister for Health. The HRCDC comprises a broad base of individuals that are representative of the health research community, including patient and public representatives.

The HRCDC will consider whether or not a consent declaration should be made on the basis of applications made to it. There is provision for an appeal from the decision of the HRCDC to an independent appeal panel appointed by the Minister.

From time to time, the HRCDC may have vacancies on the committee.  If you have an interest in joining the committee,  please email the HRCDC Secretariat; [email protected]

The Committee may:

• Make a consent declaration
• Make a consent declaration subject to conditions attached
• Not make a consent declaration
• Revoke a consent declaration

Applications for a consent declaration will be assessed by a minimum of seven members of the HRCDC, at least one of whom will be the Chairperson or Deputy Chairperson and one of whom is a data subject representative.

Additional information and consultation:

• The HRCDC may request additional information – this information must be provided by the Applicant within 15 working days of the request being made or the application will be refused.
• The HRCDC may consult with any person who it believes can assist it in its deliberations.

The Secretariat supports the HRCDC in all aspects of its work. The Secretariat is responsible for the application process which shall to enable researchers seek a consent declaration from the HRCDC.

This Secretariat shall: –

• Act as the central point of contact and help desk for the health research community;
• Support the HRCDC’s activities;
• Facilitate and manage the process for applying for a consent declaration;
• Monitor declarations made;
• Oversee the standard operating procedures of the HRCDC;
• Coordinate training and professional development activities for the HRCDC

The Secretariat staff; 

For general queries on the HRCDC Application process please contact [email protected]

Bríd Burke, Programme Manager | [email protected]

Jonathan Barrett, Programme Officer | [email protected]

Caroline Byrne, Administrative Assistant | [email protected]

Annual activities report

The HRCDC Annual activities report for 2023 can be viewed here: HRCDC Annual activities report 2023

The HRCDC Annual activities report for 2022 can be viewed here: HRCDC Annual activities report 2022

The HRCDC Annual activities report for 2021 can be viewed here: HRCDC Annual activities report 2021

The HRCDC Annual activities report for 2020 can be viewed here: HRCDC Annual activities report 2020

The HRCDC Annual activities report for 2019 can be viewed here: HRCDC Annual activities report 2019

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Public Health Agency - Research & Development in Northern Ireland

Research in the hsc.

In accordance with the  UK Policy Framework for Health & Social Care  Research (2017) , Research Governance compliance is required before a research study can commence in Health and Social Care Trusts (HSC) in Northern Ireland.

All research applications must be submitted using the web-based  Integrated Research Application System (IRAS).

Before submission you should consider :

• Make contact with the appropriate HSC Trust Research Office(s) at an early stage
• Consider feasibility including patient/client population and input from HSC support services (Pharmacy, Laboratory, Radiology etc)
• Evidence of funding (attribution of research costs)
• Sponsorship

Full guidance is available on the  Integrated Research Application System (IRAS)  Website

Researchers working with NHS/HSC organisations across England, Northern Ireland, Scotland and Wales now benefit from a consistent package to support study set-up and delivery across the UK.

Part of submission includes a  Local Information Pack (LIP)  for commercial and non-commercial research. This contains an  Organisation Information Document (OID)  (which replaces the  Site Specific Information form , used previously in Northern Ireland). For more information and guidance on the UK Local Information Pack please visit  IRAS Help . A slideshow presentation which explains the procedure is also available to download if you  click here .

Examples of completed SoECAT and OID templates are also now available on the Four Nations NHS/HSC Compatibility website on the  UK Local Information Pack: Questions and Answers  page. 

HSC Trust Research Application Guidance (v7.0)

Click here to  download the uk framework for health & social care research.

The Health Research Authority and the health departments in Northern Ireland, Scotland and Wales have developed a policy framework, which sets out principles of good practice in the management and conduct of health and social care research in the UK. This applies to health and social care research involving patients, service users or their relatives or carers, including research involving them indirectly e.g. using information that the NHS or social care services have collected about them. It is for organisations and individuals that have responsibilities for health and social care research including funders, sponsors, researchers and their employers, research sites and care providers. Click here to watch a short animation about what the framework is about (please note that this will open "youtube"):  https://youtu.be/hV_ccr5p2XU

Determine whether your study is research

For the purposes of research governance, ‘research’ means the attempt to derive generalisable new knowledge by addressing clearly defined questions with systematic and rigorous methods. Although some research projects include evaluation, where a project is considered to be solely audit or service/therapy evaluation, it will not be managed as research within the NHS/HSC or social care. Such projects do not require ethical review by a NHS/HSC or Social Care Research Ethics Committee or management permission through the NHS/HSC R&D office.

To help you decide whether your project is classified as research, the  Health Research Authority (HRA)  provide guidance  (HRA website)  and a  Decision Tool

R&D Application Gateway

The R&D Application Gateway acts as the national co-ordinating function for Northern Ireland, that co-ordinates the study-documentation, and subsequent amendments. The Gateway’s role is to facilitate and support the application process by working in partnership with the  HSC Trust R&D Offices  and Sponsors/applicants, to ensure that all research applications, including amendments, are managed in a timely and efficient manner.

Please download a set of  Frequently Asked Questions  if you want to learn more about how the Gateway works.

Contact details Tel:  (028) 7161 1126      Email:  [email protected]

How long will approval take? 

The documents below contain combined metrics for the 5 HSC Trusts in NI relating to the time for research governance approvals. These reports are issued by the Trust Research Office Managers.

Jan-Mar 2016       Apr-Jun 2016       Jul-Sep 2016        Oct-Dec 2016

Jan-Mar 2017       Apr-Jun 2017       Jul-Sep 2017        Oct-Dec 2017

Jan-Mar 2018       Apr-Jun 2018       Jul-Sep 2018        Oct-Dec 2018

Jan-Mar 2019

Governance Arrangements for Research Ethics Committees (GAfREC)

The Health Research Authority and the UK health departments in Northern Ireland, Scotland and Wales have published revised  Governance Arrangements for Research Ethics Committees . 

Health and social care research can sometimes involve an element of risk, but it’s essential that this doesn’t compromise the dignity, rights, safety and well-being of the people who take part. To make sure that this is the case, Research Ethics Committees scrutinise research proposals before approving them to go ahead. This policy document sets out when review by a Research Ethics Committee (REC) is required and what’s expected from committees reviewing health and social care research proposals. These governance arrangements cover the principles and standards for RECs, including their composition, management and accountability. Click here to download the new edition of the governance arrangements,  GAfREC 2018 , issued on 18 June 2018.

Trinity College Dublin, The University of Dublin

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You are here Research > Research Ethics Committee

Faculty of Health Sciences Research Ethics Committee

Faculty of Health Sciences Ethics Committee, Level 3 are not using REAMs. Please download the application in (Apply to FEC) and submit to ethicscomm [email protected] .

DPO review of your documents will also be required and your study should not commence until you receive DPO approval. Revised PIL's and consents forms following DPO approval MUST be sent to the faculty ethics office prior to study commencement.

• Choosing the Right Committee
• Schedule of Faculty REC
• Apply to Faculty REC

Stephen Chanock Recognized at Joint Euro-American Forum on Cancer

May 1, 2024 , by Jennifer K. Loukissas, M.P.P.

In April 2024, the All-Island Cancer Research Institute and Ireland’s Department of Health, in collaboration with major cancer organizations including the National Cancer Institute, hosted the Joint Euro-American Forum on Cancer in Dublin, Ireland. The Forum marked the 25 th anniversary of the Ireland-Northern Ireland-US NCI Cancer Consortium tripartite initiative, the major health dividend of the Good Friday Agreement, and featured scientific talks from experts in a range of disciplines.  

DCEG Director Stephen J. Chanock, M.D. , participated virtually and gave a scientific talk which began with a celebration of the 25-year partnership and emphasized the critical importance of large-scale collaborations for research efforts, including his work on mapping genetic susceptibility to cancer. He gave a brief overview of investigations into kidney cancer and an overview of the Confluence Project on breast cancer, which includes data from Ireland. Dr. Chanock ended his remarks by highlighting the many Irish scientists who have trained or worked in DCEG over the past three decades, including current fellows and Associate Director for Biological Resources, Amanda Black, Ph.D., M.P.H. 

Later in the program, Dr. Chanock was recognized for his support for the tripartite initiative which aims to reduce cancer incidence and mortality on the island of Ireland through cross-border and transatlantic collaborations in cancer research and education. The award was presented virtually by Her Excellency Geraldine Byrne Nason, Irish Ambassador to the US. Ms. Nason thanked Dr. Chanock for his dedication, leadership, and efforts to improve cancer research on the island of Ireland and unwavering support of the consortium.  

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Data Protection and Research in Health and Social Care

NOTE: The content of this page is new. Please give us your feedback to help us improve it.

All research conducted by the HSE and its funded organisations must comply with relevant Data Protection legislation . This includes obtaining consent from the prospective participants for the processing of their personal data for research purposes as part of the overall process of obtaining consent .

Read the Health Research Data Protection Network (HRDPN) Guide document for health researchers to understand what personal data refers to, and the principles of data protection before commencing the research.

Steps to follow before starting a research project that involves the use of personal data

Sharing of personal data arising from research.

• Access to personal data to select suitable candidates for research

Research involving the review of existing healthcare records (Retrospective Chart Reviews)

Consent for the processing of personal data for research purposes, contact details for the health service data protection officers.

• Easy access to Templates and Tools Related To research and Data Protection

Practical Guidance On Data Protection For Health Researchers

• Understanding GDPR,  the Health Research Regulations 2018, and subsequent amendments

Further Information

The steps on this page will help researchers to comply with data protection requirements.

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Data sharing of personal data arising from the research study may be required within the HSE or with a third party. Note that All HSE healthcare sites are considered a single legal entity for the purpose of data sharing. S38 and S39 organisations, although funded by the HSE, are independent legal entities and are therefore a third party for data sharing.

• Sharing personal data arising from research within the HSE : This can be done without needing a data-sharing agreement.
• The entity that intends to share its data (the data exporter) must enter into a Data Sharing Agreement (DSA) with the entity that will receive the data (the data importer).
• If the research project requires the transfer of personal data outside the EEA or with a Country with no Adequacy Decision ( EC Adequacy Decision ) then the HSE Transfer Impact Assessment is also required
• For guidance see the HSE R&D webinar on Research Data Transfers on HSE Land or download the webinar slides. and visit the HSE Data Protection pages

Access to personal data to find suitable candidates for research study

Healthcare professionals, or other employees of the data controller (i.e a healthcare records clerk), who normally have access to personal data for healthcare, can access such records to determine eligible research participants (pre-screening) . This does not require the explicit consent of the data subject, not REC approval, provided that measures are in place to appropriately inform service users that these activities are taking place. Privacy statements and transparency notices must be appropriately displayed.

However, access to such records for the same purpose by research personnel under the direction of HSE staff but employed by an academic institution can only be done if:

• The individual has been formally authorized. A formal pre-screening agreement must exist between the HSE/Hospital and the employer of the individual. The individual must be appointed as an Authorised person by the HSE and his/her Appointment must be activated for specific projects.
• Be formally seconded to the HSE/Hospital. A secondment agreement can be put in place for a single individual or fully for the organisation. To access a secondment agreement template for this purpose, please get in touch with National HSE R&D .

Always ensure that appropriate transparency measures are in place to keep the patients and the public appropriately informed about how their data may be used for research.

For further guidance visit:

• The Department of Health website
• Download explanatory slides
• HSE National Policy for Consent in Health and Social Care

What is a retrospective chart review (RCR):

• The retrospective chart review (RCR), also known as a medical record review, is a type of analysis that involves the use of pre-recorded, patient-centered data to answer one or more questions.
• The data used in such reviews exist in many forms and it is a popular methodology widely applied in many healthcare-based disciplines such as epidemiology, quality assessment, professional education and residency training, inpatient care, and clinical research, and valuable information may be gathered from study results to direct subsequent prospective studies ( Vassar & Holzmann, J Educ Eval Health Prof. 2013)

The importance of defining the purpose of a retrospective chart review upfront.

• While retrospective Chart Reviews (RCR) can be used for several purposes, i.e  research, clinical audit, service evaluations, etc;  the governance route is different depending on the purpose of the review
• RCR conducted for research purposes must be submitted to a HSE or Hospital Research Ethics committee, while those conducted for audit or evaluation purposes should follow the clinical governance path as outlined by their organisation.
• Hence it is very important to try and define the purpose of the RCR as early as possible during the study design to ensure the appropriate governance path is followed.

Consent and Data protection considerations for retrospective chart reviews for research purposes.

From a data protection perspective, a retrospective chart review for research purposes is a research study involving the analysis of personal data already collected for the provision of healthcare by the data controller, which is carried out by a staff member of the data controller of such data..

• In all cases, a RCR carried out for research purposes must be approved by an appropriate Research Ethics Committee.
• By law, a retrospective chart review done for research purposes that involve the use of personal data without the explicit consent of the data subject can only be carried out if the risk to the data subject is low. To determine the risk, the risk scoring tool can be used.
• If the risk is not deemed low, the research can only be carried out if a Consent Declaration from the Health Research Consent Declaration Committee is obtained. Submission to the HRCDC for a consent declaration must be accompanied by a Data Protection Impact Assessment annotated by the DPO and approved by an appropriate REC.
• If the data has been collected with explicit consent from the data subject for use for research purposes, the above is not required.
• In all cases, the data controller organisation displays posters and privacy notices to inform the service users of data processing matters related to RCRs.

Who can carry out a retrospective chart review for research purposes?

Only certain classes of persons are permitted under law to conduct a retrospective chart review study for research purposes without ‘explicit consent’ or a ‘consent declaration’

RCR for research purposes on identifiable personal healthcare data can only be carried out by:

• Employees who ordinarily have access to records e.g. healthcare professionals, medical records clerks
• Students on placement who are in training to become a ‘healthcare practitioner’ (All students, including student nurses and doctors, must be “under the direction and control” of the HSE service or Hospital at all times.)

Can personal data collected during a retrospective chart review study be shared or published?

The personal data accessed under these conditions and used for a research retrospective chart review cannot be used for other purposes. The data used for a research retrospective chart review by the above authorised individuals cannot be shared with others (third parties) unless it is fully anonymised. Any published results must not be identifiable.

For further information visit:

• S.I. No. 18/2021 – Data Protection Act 2018 (Section 36(2)) (Health Research) (Amendment) Regulations 2021
• HSE National Policy for Consent in Health and Social Care Research.

The Health Research Regulations 2018 place additional consent requirements for the  processing of personal data for research  in Ireland. The HSE National Consent Policy for Health and Social Care Research explains how to comply with data protection requirements in common scenarios. It also explains how to obtain valid consent for the use of personal data for future research purposes. Such consent, while it may be broader it needs to be as informed as possible. In addition, the choices made by the participant have to be appropriately recorded and documented (explicit).

In certain circumstances, when the explicit consent of the individual for the processing of personal data for research purposes cannot be obtained, researchers can apply to the Health Research Consent Declaration Committee HRCDC for a consent declaration. The application needs to be accompanied by a research ethics committee approval and a DPIA annotated by the data controller DPO. The HRCDC will evaluate the merit of the research proposal and ultimately decide whether the public interest outweighs the rights to privacy of the data subjects concerned.

• Hospital DPOs  (PDF)
• CHO DPOs  (PDF)
• HSE Corporate and National divisions DPO (Email)

Easy access to Templates and Tools Related to research and Data Protection

• Workflow tools to determine the data controller and data processor roles
• Risk Scoring tool to determine the need to complete a DPIA (Download Excel file)
• Data sharing agreement template (Download Word file)
• HSE DPIA Template (Download Word file)
• Companion Guide to Complete Health Research DPIA Template (Download PDF file)
• Pre-screening agreement (Download Word file)
• Authorisation form for Pre-screening (PAS-Vetting Form) (Download Word file)
• Activation Form for Pre-screening Authorised Person (PSAP-Activation Form) (Download Word file)
• HSE Privacy Statement and Privacy Notice (HSE R&D & HSE DPO Office) (Dowload PDF file)
• Transfers of Personal Data outside the EEA TIA Form (Download Word file)
• Download HRDPN Guidance for Researchers on Data Protection (Download PDF file)
• Data Protection in Research Essentials for HSE Researchers (Download PDF file)
• Data Processing Mapping and Data Controllers & Data Processors Determination (Download PDF file)
• HSE International Transfer of Personal Data: Special Rules, FAQs, Glossary
• EDPB Guidelines on Data Controllers and Data Processors
• Link to HSE Research R&D Seminars page
• GDPR training (HSE only)

Understanding GDPR, the Health Research Regulations 2018, and subsequent amendments

The GDPR  ( General Data Protection Regulation (EU) 2016/679 ) came into force across all of Europe on 25th May 2018 replacing the Data Protection Directive (95/46/EC). 

The GDPR provides a single set of rules for all EEA organisations to ensure that data protection underlying concepts and principles remain the same in all Member States.  

If you collect, use or store personal data, digital, manual, handwritten, or any type of record, then GDPR affects you.

The DPA 2018 ( Data Protection Act 2018)  gives effect to certain aspects of the GDPR in Irish Law. Section 36(2) of the DPA 2018 the “Health Research Regulation” ( HRR ) addresses specific health research requirements.  HRR S.I No. 314 of 2018

The Health Research Regulations were amended in 2021 to address  five substantive areas , 

• Processing of personal data to establish suitability or eligibility for inclusion in health research ( Pre-screening )
• Carrying out  low-risk retrospective chart reviews
• Deferred consent   for the processing of personal data for health research in exceptional situations
• Informed consent for health research obtained during the time of the EU Data Protection Directive
• Explicit co n sent for processing personal data in a health research context
• Suitable and Specific Measures (Source: HRB)
• Consent (Source: HRB)
• Consent Declaration (Source: HRB)
• Privacy Notice (Source: HRB)
• Data Protection Commission: GDPR Basics
• Understanding the GPR in a wider Legal Framework  (Youtube video; source: HRB)
• HRR FAQ  (Source: HRB)
• European Commission EU data protection rules  (source: European Commission)

Research Legal Advice Request

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updated 16/04/24

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Research: More People Use Mental Health Benefits When They Hear That Colleagues Use Them Too

• Laura M. Giurge,
• Lauren C. Howe,
• Zsofia Belovai,
• Guusje Lindemann,
• Sharon O’Connor

A study of 2,400 Novartis employees around the world found that simply hearing about others’ struggles can normalize accessing support at work.

Novartis has trained more than 1,000 employees as Mental Health First Aiders to offer peer-to-peer support for their colleagues. While employees were eager for the training, uptake of the program remains low. To understand why, a team of researchers conducted a randomized controlled trial with 2,400 Novartis employees who worked in the UK, Ireland, India, and Malaysia. Employees were shown one of six framings that were designed to overcome two key barriers: privacy concerns and usage concerns. They found that employees who read a story about their colleague using the service were more likely to sign up to learn more about the program, and that emphasizing the anonymity of the program did not seem to have an impact. Their findings suggest that one way to encourage employees to make use of existing mental health resources is by creating a supportive culture that embraces sharing about mental health challenges at work.

“I almost scheduled an appointment about a dozen times. But no, in the end I never went. I just wasn’t sure if my problems were big enough to warrant help and I didn’t want to take up someone else’s time unnecessarily.”

• Laura M. Giurge is an assistant professor at the London School of Economics, and a faculty affiliate at London Business School. Her research focuses on time and boundaries in organizations, workplace well-being, and the future of work. She is also passionate about translating research to the broader public through interactive and creative keynote talks, workshops, and coaching. Follow her on LinkedIn  here .
• Lauren C. Howe is an assistant professor in management at the University of Zurich. As head of research at the Center for Leadership in the Future of Work , she focuses on how human aspects, such as mindsets, socioemotional skills, and leadership, play a role in the changing world of work.
• Zsofia Belovai is a behavioral science lead for the organizational performance research practice at MoreThanNow, focusing on exploring how employee welfare can drive KPIs.
• Guusje Lindemann is a senior behavioral scientist at MoreThanNow, in the social impact and organizational performance practices, working on making the workplace better for all.
• Sharon O’Connor is the global employee wellbeing lead at Novartis. She is a founding member of the Wellbeing Executives Council of The Conference Board, and a guest lecturer on the Workplace Wellness postgraduate certificate at Trinity College Dublin.

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