Guidance for CLAHRC EoE researchers
It is important to establish from the outset whether a project is likely to be research or not, as projects NOT classed as research do NOT require ethical approval to be granted by a REC (Research and Ethics Committee). Guidance from the Health Research Authority (HRA) on ‘what is research?’ can be found here, and this document Defining Research, provides further guidance on distinguishing research from clinical audit and service evaluation, and indicates whether review by a REC is required.
If you think your project is research, then you should register on IRAS, (the Integrated Research Application System) which is a ‘one-stop shop’ for applying to multiple agencies such as the REC, R&D, MHRA etc. If your research involves NHS patients, staff and/or facilities, your research cannot proceed without formal approval from the R&D Office(s) at each of the NHS Trusts in which your research is to take place.
If the project is audit, service evaluation, public health surveillance, practice development, quality or service improvement, action research, service design or development, a case study or satisfaction survey, then this is not classed as research, but we still require you to complete the Governance data input tab on the CLAHRC EoE KPI tool.
You should also check with the clinical governance office for the NHS organisation where you will be conducting the study what other review arrangements or sources of advice apply to the project. For example, there may be standard guidelines on the conduct of clinical audit.
If your project is research, contact the Lead Organisation’s Research & Development Department.
If your project is non-research, contact the Lead Organisation’s Clinical Audit or Service Evaluation/Development Department.
Managing the research governance requirements:
- Guidance on research, audit, service development and Ethics Committees from CPFT can be found here.
- Information on the research passport system from the NIHR can be found here.
- Guidance from the University of Cambridge School of Clinical Medicine on research governance can be found here.
The process can be daunting as this flowchart demonstrates, so please ensure that all steps are taken and if in doubt, contact the CLAHRC manager for assistance.
Research Strategy Office Guidance: Concordate to Supporting Research Integrity (University of Cambridge)
The guidance provides a link to the Universities UK ‘Concordat to Support Research Integrity’, compliance to which is a requirement for Higher Education Funding Council for England (HEFCE) and Research Councils UK (RCUK). Also included are links to University policies and statements (good research practice guidelines; misconduct in research; and ethics for human participation (and use of animals) in research), and recommendations for compliance to the concordate.
To see the guidance document, please click here.
Health Research Authority toolkits
Two online toolkits by the HRA are available:
The first is a way of deciding whether or not your project is categorized as research rather than audit or service evaluation, and the second is for deciding whether or not NRES ethics approval is required. The links to the toolkits are below:
- Toolkit – Is my study research?
- Tookit – Do I need NHS REC approval?