When does the University's Research Governance Procedure apply?
The University's Research Governance Procedure applies when a project, which is classified as research by the NHS/Health Research Authority (HRA):
- involves* the NHS/services provided by the UK Health Departments; AND/OR
- involves* social care services provided by a local authority (including organisations providing services under contract with a local authority) or prison health services; AND/OR
- requires review by an NHS research ethics committee
- when a project not necessarily classified as research by the HRA, and not falling into one of the above categories, has been flagged by the University ethics reviewers as a medium/high risk human-interventional study.
*Involvement refers to where the service has a duty of care to the research participants, either as patients/service users or staff/volunteers. References to participants include people whose data or tissue is involved in a research project.
Definition of research
The NHS/HRA have a decision tool and a definitions table available to help you decide if your project is classified as research according to the NHS/HRA:
Decision tool: http://www.hra-decisiontools.org.uk/research/
These aim to help researchers differentiate between research, audit, service evaluation and investigations of usual practice. However, please be aware that for the purposes of ethical review for research involving human participants, the University's definition of research is broader than that of the NHS/HRA, and hence work not classed as research by the NHS/HRA may still require University ethics review. The University's definition of research for the purposes of ethics review can be found in the ‘General Principles and Statements’ Section of the Research Ethics Policy.
Review by an NHS research ethics committee
There is a straightforward tool which will help you to establish whether NHS research ethics committee review is required available from the HRA website:
Ethics decision tool: http://www.hra-decisiontools.org.uk/ethics/