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 4.1 of The National Review of Clinical Audit (November 2019) differentiates between a variety of activities as follows:
Understanding the Difference between Research and Other Activities
|Theme||Clinical Audit||Service Evaluation||Research|
|Definition||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||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 is designed and conducted to generate new generalisable or transferrable knowledge. It includes both qualitative and quantitative studies that aim to generate new hypothesis as well as studies that aim to test existing or new hypothesis.|
|Answers Question||Clinical audit demonstrates whether a predetermined standard is being met.||Service evaluation tells how well a service is working.||Research demonstrates what should be done.|
|Purpose||To find out if best practice is being practised for quality assurance and improvement purposes.||To evaluate current practices for information purposes. The information can inform management decisions.||To generate new knowledge and find out what treatments, interventions or practices are the most effective.|
|Context||Carried out at local or national level.||Carried out at local level only.||Carried out at local or national level.|
|Methods||Measures practice against evidence-based clinical standards.||Measures current service without comparison against standards.||Has a systematic, quantitative or qualitative approach to investigation.|
|REC Review||No, but ethical considerations should still be considered.||No, but ethical considerations should still be considered.||Yes|
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.