The UK has a range of bodies which have roles in regulating different aspects of health research in humans. The Health Research Authority (HRA) provides Research Ethics Committees and the Confidentiality Advisory Group, which review applications to undertake certain types of research. They also work with other bodies to coordinate the overall system for regulation and governance of research.
Determining whether NHS ethical review is required
This decision tool will help you to determine if your study requires approval from an NHS Research Ethics Committee (REC). If NHS REC approval is required, University of Leeds ethical review is not normally needed in addition.
There is also a decision tool to help you decide whether or not your study is research. You may also find it helpful to refer to the guide for Clinical Audit, Research and Service Review.
More detailed information, including some examples, is available in the document: Does my project require review by a Research Ethics Committee?
Refer to the Governance Arrangements for Research Ethics Committees (GAfREC) guidelines for further information.
Once you have NHS ethical approval in place please inform your Research Ethics Administrator.
HRA Confidentiality Advisory Group (CAG) approval is required for patient identifiable information collected without explicit consent.
Applying for NHS REC review
The Integrated Research Application System (IRAS) is a single online system for applying for permissions and approvals for health and social care/community research in the UK.
In 2015 the HRA introduced a new combined process for applying for the various permissions and approvals called HRA Approval. This new approval process is being rolled out in phases. Some studies taking place solely in England are now eligible to apply for HRA Approval.
Applications for HRA Approval are made via IRAS. Guidance for applicants is available in IRAS and via the HRA website.
- Guidance on using IRAS
- Guidance notes for completing an IRAS form
- Standard sponsor review guidance for IRAS applications (updated July 2021)
- HRA guidance on the design of participant information sheets and consent forms
A Central Booking Service (CBS), has been introduced to cover all bookings for NHS Research Ethics Committees in the UK. This replaces the previous Central Allocation System, Proportionate Review Allocation Systems and Local Allocation Systems.
Information about the Proportionate Review Service – for low-risk research studies.
It’s important to explain to research participants how their personal data will be used, and what their rights are. Privacy Notices need to be concise, easily accessible to participants and easily understandable.
- NHS Health Research Authority recommended transparency wording
- MRC guidance on transparency
- Guidance on producing a privacy notice, including a template for research participants.
- Health Research Authority bite-size eLearning modules aimed at students and their academic supervisors
- HRA runs regular training days for researchers new to the NHS ethical review process.
- OD&PL training courses
- NHS research ethics study day 2015
NHS management permission (R&D approval)
- Research requiring NHS R&D review but not ethical review
The Leeds R&D Office
For enquiries about the R&D approval process, you can contact R&I Coordinators. If you would like someone to review a research proposal and confirm whether it is a research or audit/service evaluation then please contact Anne Gowing, Research Governance Manager.
HRA Guidance on Student Research
A comprehensive guidance document on student research is now available on the HRA website. This collates and updates previous guidance from NRES, as well as relevant guidance developed in consultation with the NHS R&D Forum within the Integrated Research Application System (IRAS).
- Sponsor responsibilities
- HRA expectations of sponsors
- Standard sponsor review guidance for IRAS applications
Social care research
Most social care research needs NHS Social Care REC review. The SCREC only reviews adult social care studies, those involving children can still be reviewed by a University ethics committee. The SCREC can also review research within the NHS that uses social science or qualitative methodology, provided that the research does not involve any clinical interventions or changes to clinical care. Applicants are advised to contact the SCREC for advice on whether SCREC review is required or if University review would be appropriate.
Further information and advice
- Leaflet on GCP training requirements for researchers
- Royal College of Physicians Guidelines on the practice of ethics committees in medical research with human participants
- Understanding Patient Data initiative – new April 2017.
For advice and guidance on applying for NHS ethical review please contact Jean Uniacke, email@example.com.