The definition of research adopted in the HSE Action Plan for Health Research 2019–2029, is that of “the attempt to derive generalizable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods.”
Health and social care research is defined in the Health Research Regulations 2018 as follows:
- Research with the goal of understanding normal and abnormal functioning, at molecular, cellular, organ system and whole body levels;
- Research that is specifically concerned with innovative strategies, devices, products or services for the diagnosis, treatment or prevention of human disease or injury;
- Research with the goal of improving the diagnosis and treatment (including the rehabilitation and palliation) of human disease and injury and of improving the health and quality of life of individuals;
- Research with the goal of improving the efficiency and effective-ness of health professionals and the health care system;
- Research with the goal of improving the health of the populations a whole or any part of the population through a better under-standing of the ways in which social, cultural, environmental, occupational and economic factors determine health status.
- Health Research may also include action taken to establish whether an individual may be suitable for inclusion in the research.
Differentiating Research from Other Activities
Research is often confused with other activities requiring a rigorous approach to methodology in terms of design, procedure, analysis and interpretation of data. Research is a separate activity however, from clinical audits, standard service evaluations, or public health or advanced health analytics work carried out by the HSE for the purpose of carrying out its legal obligations for the planning and delivery of health and social care services.
Table – Differentiating research from other processes (as per the National Review of Clinical Audit 2019)
|Theme||Research||Clinical Audit||Registry||Service Evaluation|
|Definition||Research is designed and conducted to generate new generalisable or transferrable knowledge. It includes both quantitative and qualitative studies that aim to generate new hypotheses as well as studies that aim to test existing or new hypotheses.||Clinical audit is a clinically led quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and acting to improve care when standards are not met.||Registries are systems which collect a defined minimum dataset from patients with a particular disease, undergoing a particular procedure or therapy, or using a healthcare resource.||Service evaluation seeks to access how well a service is achieving its attended aims. It is undertaken to benefit the people using a particular healthcare service and is designed and conducted with the sole purpose of defining or judging the current service.|
|Research demonstrates what should be done.||Clinical audit demonstrates whether a predetermined standard is being met.||Registries show the details of certain patient groups. They can be used to answer both clinical audit and research questions.||Service evaluation tells how well a service is working.|
|Purpose||To generate new knowledge and find out what treatments, interventions or practices are the most effective.||To find out if best practice is being practiced for quality assurance and improvement purposes.||To monitor a patient population or healthcare process. A registry may have an improvement aim, a cost focus or form an epidemiological database used for research.||To evaluate current practices for information purposes. The information can inform management decisions.|
|Context||Local or national level.||Local or national level.||National level only.||Local level only.|
|Method||Has a systematic, quantitative or qualitative approach to investigation.||Measures practice against evidence-based clinical standards.||Carries out data collection and analysis.||Measures current service without comparison against standards.|
|Requirement for REC Review||Yes.||No, but ethical considerations should be considered.||Yes, if for the purposes of research.||No, but ethical considerations should be considered.|
When in doubt, you should contact your local Research Office, Research Ethics Committee Manager, or Audit Office for advice.
Why is it important to determine whether your activity is research or not?
If your activity is a form of Research, and depending on the nature of it, it will most likely require compliance with the Health Research Regulations 2018 and amendments, including Research Ethics Committee approval and explicit consent from participants.
If your activity is not Research the general GDPR legislation still applies.