For Trust staff, please visit the Intranet page
Before a project is started, it is important to understand whether it is research, audit or service evaluation.
“Research” implies seeking “new, generalisable knowledge” or testing a hypothesis or question. Service evaluation and clinical audit projects do not require NHS Research Ethics or R&I approval. Some studies require HRA approval but do not require REC approval.
When considering whether a project is research, consulting with the ‘HRA decision tool’ will help clarify this.
Is it research? – http://www.hra-decisiontools.org.uk/research/
Do I need NHS REC review? – http://hra-decisiontools.org.uk/ethics
If the above guides were inconclusive, for further assessment of the project:
To be certain of what is required, please contact R&I for advice because if a project is not research it may still require other permissions or approvals to be undertaken.
Ethical & HRA approvals, IRAS form & study documents
Before research can be started, approvals from a research ethics committee (REC) and the health research authority (HRA) are required.
To apply for REC & HRA approvals, an IRAS form must be completed.
The form must also be reviewed and approved by the research sponsor. At LTHT the sponsor team will provide support on how to complete the IRAS form and the supporting study documents.
The IRAS website also has e-learning and further information on this process:
https://www.myresearchproject.org.uk/Home.aspx
The specific requirements of this process can vary depending on the study type, please contact the LTHT sponsor team at [email protected] for further support. R&I also has a PPIE team that can help with the development of patient facing documents.