Clinical Audit, Service Evaluation and Research

There are many definitions of research, audit and service evaluation and it can be confusing for researchers to establish into which category a project falls.

Projects involving human participants will need to be registered on a trial database and might also require ethical approval by the lead organisation’s ethics committee and an external ethics committee. For further guidance on ethical approval, please check Appendix C in the quick guide on how to set up a clinical trial.

For some help establishing category a project falls into, see links below.

NIHR – Research, service evaluation or audit?

KCL – Is my project research, service evaluation or audit?

HRA – Decision tool table: activities in healthcare

HRA – Is my study research?

Research

Definition

Research activities are defined by the conventions set out in the Frascati Manual (2015).

Research and experimental development (R&D) comprise creative and systematic work undertaken in order to increase knowledge - including knowledge of humankind, culture, and society - and to devise new applications of economic, cultural, or social value of available knowledge.

Basic research is experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena, observable facts, and behaviours, without any particular application or use in view.

Applied research is an original investigation undertaken in order to acquire new knowledge. It is, however, directed primarily towards a specific intended aim or objective.

Experimental development is systematic work, drawing on knowledge gained from research and practical experience and producing additional knowledge, which aims to produce new products, experiences or processes, or to improve existing products, experiences or processes.

Registration and ethical approval

King’s College London (KCL)

Some research projects involving human participants may require registration and ethical approval. This can be done via the Research Ethics Management Application System (REMAS) portal by a KCL staff or student. Staff will need to establish the risk level of their project using the risk checklist and follow the adequate registration process. For more information see KCL Research Ethic Committee (REC) website and registration processes.

For guidance on ethical approval requirements external to KCL, see the KCL REC website.