The UK Health Research Governance Framework defines research as:
‘the attempt to derive generalizable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods ‘
Research is often confused with other activities requiring a rigorous approach to methodology in terms of design, procedure, analysis and interpretation of data, such as clinical audit, health service evaluation and some other forms usual practice. However, they are not the same.
The Health Research Board (HRB) has published guidance to help differentiate research from clinical audit, evaluation and usual practice. Read more details from the HRB
As articulated in the Health Research Regulations 2018, Health Research includes:
- research with the goal of understanding normal and abnormal functioning, at the 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 effectiveness of health professionals and the health care system
- research with the goal of improving the health of the population as a whole or any part of the population through a better understanding of the ways in which social, cultural, environmental, occupational and economic factors determine health status
Why is it important to determine whether your activity is research or not?
If your activity is Research, your project may require the approval of a Research Ethics committee and must also comply with the Health Research Regulations 2018.
If your activity is not Research you don’t require approval from a Research Ethics Committee, you are not required to comply with the Health Research Regulations 2018, but the general GDPR legislation still applies. However, if you are planning to publish your clinical audit or service evaluation results some journals have a policy that requires you to go through a research ethics committee. Therefore it is worth checking with the journal that you hope to publish with before commencing your audit or you may prefer other journals that do not have this as a requirement.
For further clinical audit related guidance, see the NOCA GDPR Guidance.