What is a Research Ethics Committee?
A Research Ethics Committee (REC) is the acknowledged international best practice structure for overseeing the conduct of ethical standards in healthcare research. A HSE Research Ethics Committee has three main functions:
- Protection: to contribute to safeguarding the dignity, rights, safety and well being of all actual or potential research participants (WHO 2002), to weigh the risks and benefits for research participants, to protect the rights of researchers to carry out legitimate investigation; and the HSE’s reputation for research conducted and sponsored by it.
- Advice: can advise individual researchers on whether a research project requires research ethics review, if it is likely to be harmful or offensive to participants, the broader community or the HSE.
- Research quality: for research to be ethical it must be scientifically sound – poorly planned and conducted research is not ethical.
Details of available RECs
The HSE Research and Development Office advises that, at present, studies involving multiple healthcare sites, require multiple REC approvals with the exception of Clinical Trials for Investigational Medicinal Products (CT-IMPs) and Clinical Investigations with Medical Devices. In these cases, a single approval can be sought from the National Research Ethics Committee (NREC).
Find below details of RECs approving research projects outside the remit of the NREC.
If you need any advice on which Reference REC you should apply to please contact the R&D team (HSE.REC@hse.ie) (Note: for advice on REC requirements and forms please contact the relevant REC).
For more information see https://hseresearch.ie/
Please visit the Department of Health webpage for information about ethics committee approval for clinical trials:
Specific activities requiring Research Ethics Review
- Clinical trials involving human participants
- Testing of new treatment or interventions or medical devices
- Observational clinical research
- Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological fluids
- Testing innovative practices in health and disability services
- Qualitative research involving access to personal information by means of questionnaires, interviews or focus groups
- Research involving the secondary use of data (use of data not collected for that research purpose), if any form of identifier is involved and/or if personal health information pertaining to individuals is involved
- Physiological studies
- Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other procedures which are not recognised as established by virtue of their recent development, discovery or use in a new or unfamiliar way
- Research conducted by students, which include all activities that meet the definition of research with human participants. The Irish Council for Bioethics state that RECs should review research protocols with a view to contributing to the student’s education in scientific and ethical principles governing research
- Case studies, when a series of subject observations allow possible extrapolation or generalisation of the results from the reported cases and when there is an intent to publish or disseminate data
Activities that do not usually require REC review
- Research utilising existing publicly available documents or data
- Observational studies in public places in which the identity of the participant remains anonymous
- Case study of one patient with the proviso that written informed consent has been obtained from the relevant study subject/participant
- Quality assurance studies
- Clinical Audits
- Service Evaluations
Differentiating research, audit and service evaluation
Differentiating research, audit and service evaluation can be difficult. The RCP (UK) provides a comprehensive guide to doing this. This guidance is summarised in Appendix 1a of the RCP (UK) guide.
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