Frequently Asked Questions

Any research study (and this includes research that is done by students and those in training programmes) that involves HSE patients (or their data or samples), HSE staff (or their data or samples) or HSE premises MUST HAVE a favourable opinion from a HSE REC prior to starting. There are some circumstances where REC approval may not be needed, including:

• Research utilising existing anonymised publicly available data*(*when the publicly available data has already been anonymised)
• Case study of one patient with the proviso that the written informed consent has been obtained from the relevant subject and according to the HSE Consent for Research Policy
• Advanced health analytics carried out by employees of the HSE and its funded organisations for discharging their legal obligations for the planning and delivery of health and social care services using routinely collected data
• Public Health Practice
• Infectious disease investigation and control practice

If in any doubt about whether your study needs REC approval, it is advisable to check with your local REC as retrospective approval cannot be given. More information about what is research can be found at: https://hseresearch.ie/what-is-research-2/

Research Ethics Committee approval is not needed for service evaluations unless it includes an element of research. If you are in doubt about whether your project is service evaluation or research, you can seek the view of a REC. More information about what is defined as research can be found at: https://hseresearch.ie/what-is-research-2/

Research taking place in the HSE, that involves the participation of health service users, their personal data and/or their biological samples, health and social care staff, or the use of HSE healthcare services, premises or infrastructure, either directly or indirectly, must be reviewed by a HSE Reference REC, with the exception of those research studies under the remit of the NRECs. Our website includes links to individual RECs and other information about seeking ethical review. https://hseresearch.ie/

Generally speaking there are some types of projects that do not need ethical approval including audit and service evaluation. However, there may still be ethical implications and, if they do have an element of research, they may need to be considered by a REC. Other projects that do not generally require ethical approval include:

• Research utilising existing anonymised publicly available data
• Case study of one patient if written informed consent has been obtained from the relevant subject and according to the HSE Consent for Research Policy
• Advanced health analytics carried out by employees of the HSE and its funded organisations for discharging their legal obligations for the planning and delivery of health and social care services using routinely collected data
• Public Health Practice
• Infectious disease investigation and control practice
• Quality Assurance and Quality Improvement Activities

More information about what is defined as research can be found at: https://hseresearch.ie/what-is-research-2/

All applications for ethical approval have to complete the standard application form. You can access the form from the research ethics committee that you will be applying to. A checklist of the documentation you will need to submit can also be obtained from the REC or from this website: https://hseresearch.ie/ or by contacting: HSE.REC@hse.ie You can find a list of the various RECs on our website at https://hseresearch.ie/researchers/

REC approval must be granted before starting a research study. You will need to prepare all the required documentation before submitting your application for REC approval. A checklist of the documentation you will need to submit can also be obtained from the REC or from this website: https://hseresearch.ie/ or by contacting: HSE.REC@hse.ie

Research taking place in the HSE, that involves the participation of health service users, their personal data and/or their biological samples, health and social care staff, or the use of HSE healthcare services, premises, or infrastructure, either directly or indirectly, must be reviewed by a HSE Reference REC. Currently, under both the HSE Research Governance and Management Framework and the Standard Code of Management for HSE Reference RECs you need dual ethical approval.

You will need to apply to the REC for the area(s) in which you are undertaking your research. If you are undertaking research in HSE corporate or national services, you should apply to Reference REC RHA B. You can find a list of available RECs and their coverage area on our website at https://hseresearch.ie/researchers/

The National Research Ethics Committee or NREC considers all applications for clinical trials of medical products and medical devices.

You can find a list of available RECs for the CHOs on our website at https://hseresearch.ie/research-ethics/research-ethics-committees-cho-based-research/

If this study includes dealing with HSE patients/ staff (or their data) in different sites or different community health organisations, at present you will need to obtain Ethics approval from each Research Ethics Committees (REC) for those sites or areas. You can find a list of the various RECs on our website at https://hseresearch.ie/researchers/

The first HSE Reference REC has been established for the RHA B Midlands Area and Corporate Division. It opened for applications in March 2022.

Research applications for research being carried out in the corporate and national division of HSE go to the newly formed HSE Reference REC RHA B, Midlands Area and Corporate Division.

We are establishing 6 HSE Reference RECs which will be aligned to the Sláintecare Regional Health Areas. Please email HSE.REC@hse.ie if you are interested in becoming a REC member and we will keep your name on file and notify you of opportunities as they become available. You should also look out for notifications as they appear on the website. When opportunities come up, we ask people to submit an Expression of Interest and they are then asked to attend a short skills match interview before appointment. Appointment is usually for a period of three years. https://hseresearch.ie/research-ethics/ For more information on becoming a REC member and what it involves visit our webpages and read the Standard Code of Management and Practice for HSE Reference RECs.

REC members can have different roles including lay, patient and public involvement representative (PPI), expert, deputy chair and chair. Expert members need to have relevant experience of any of the following: • A practising or retired health practitioner. • Have qualifications or experience relating to the conduct of health research (outside being a member of a Research Ethics Committee). • Have qualifications or experience in the area of ethics. • Have qualifications or experience in research methodology/ epidemiology/ statistics. Lay and PPI representatives do not need any previous experience but should have an enthusiasm for research and ethical research. To be a chair or deputy chair you need to have served on a REC as a member. Please email HSE.REC@hse.ie if you are interested in becoming a REC member.