NHS Research Ethics Committees form part of the Health Research Authority.
NHS Research Ethics Committees review research studies that involve NHS patients, their identifiable data or tissue.
NHS RECs also review studies that fall under the Mental Capacity Act.
Research studies that involve the NHS, but fall outside the remit of a NHS REC will require ethical review by BSREC/HSSREC, and HRA approval. These projects include:
- Research involving NHS staff recruited as research participants by virtue of their professional role
- Research limited to use of or access to a care organisation's premises or facilities e.g. research undertaken by a university department on NHS premises, involving healthy volunteers not recruited as NHS patients and not subject to any legal requirements
- Research involving analysis of anonymised NHS patient data, previously collected in the course of routine clinical care (i.e. not intitally collected for research purposes).
- Research involving anonymised human tissue samples, collected with consent for use in research. (Anonymised samples colllected without consent for use in research must be reviewed by a NHS REC).
You may not commence your study until you have received written approval from the NHS REC (or BSREC), written approval from the HRA and have recieved confirmation of capacbility and capacity from the sites involved in the research, as outlined in the HRA approval letter.
Please note that studies which involve the NHS in whole or in part and that, do not fall within the exclusions above must be approved by an NHS REC. In these cases the NHS REC will review the whole study and not just the part that involves the NHS.
All research in the NHS requires a research sponsor. For information on how to apply for the University to be research sponsor of your study please visit here, and contact the Research Governance team in Research and Impact Services sponsorship at warwick dot ac dot uk.
Who signs off the Sponsorship Declaration?
The Sponsorship Declaration cannot be signed by the Chief Investigator or any other member of the study team. It can only be signed by Carole Harris (firstname.lastname@example.org), Assistant Director and Head of Research Governance, Research & Impact Services (or designate) once the study documentation has been submitted to and approved by the Sponsorship & Oversight Committee.
Applications to the Ethics Committees and all Patient/Participant Information Sheets used in a study, should state contact details for the person at the University, individuals can contact should they wish to raise a complaint about any aspect of the study.
Please Do Not put the Chief Investigator, research team member, Head of Department or anyone else involved in the study, as the person to contact for complaints.