NHS Ethics

Any research on human participants needs a favourable ethics committee opinion

If your project needs an ethical review by a NHS Research Ethics Committee (REC) under the UK Health Departments, you should apply via the IRAS online system. This encompasses the legal requirements of review under the UK legislation.  For PhD student projects, application can only be submitted by the CI who would be the academic supervisor.

The Chief Investigator (CI)  is the person responsible for the conduct of the whole project in the UK. They must be able to supervise the research effectively; also be readily available to communicate with the Research Ethics Committee (REC) and other review bodies during the application process, and where necessary, during the conduct of the research.

SU Organisational Sponsorship will be required for Health and Social Care Research Projects that fall under the UK Policy Framework for Health and Social Care Research (2017). The Sponsor is normally the employer of the CI and takes on overall responsibility for legal, insurance, regulatory arrangements and safeguarding being in place to set up, run and report a research project.

The Sponsorship Authorised Signature is Dean of Academic Leadership Research Integrity and Ethics who is authorised to sign and act on behalf of the University with regard to SU Organisational sponsorship and governance matters.

The IRAS online system also enables HRA permissions and NHS R&D Capacity and Capability pathways to approvals needed for most NHS or social care research projects.

Whether you are following the HRA Approval or REC-only route, the following steps apply:

1. Complete a research application form on the Integrated Research Application System (IRAS).
2. Prepare your study documents
3. Book your application in through the Central Booking Service
4. E-submit your applications in IRAS

IRAS (Integrated Research Application System)

We would recommend you undertake the quick IRAS e-learning which will facilitate your application being accepted through Sponsorship, NHS REC, HRA, NHS C&C and dealing with any amendments, reports and the online project application management.  The training assistance will enable you to be familiar with the:

1. System
2. Authorisation
3. Submission
4. Document version control
5. Amendments 
6. Approvals
7. Help and FAQ

Do I need NHS REC approval?

The HRA decision tool will help you work out whether your study needs approval from an NHS REC.

Planning and Approval Pathways

Some helpful guides are available from the following websites:

1. www.healthandcareresearch.gov.wales/research-route-map/
2. www.hra.nhs.uk/planning-and-improving-research/
3. www.hra.nhs.uk/approvals-amendments/

Booking an NHS REC

Once SU Sponsorship in principle is authorised the next stage is to contact the Central Booking Service (CBS) to book your study into an NHS REC meeting. If you change anything after sponsorship authorisation,  this will invalidate the application and you will need to re-apply for sponsorship again. Therefore, it is best to ask for authorisation once you have all the correct document version controlled and ready to book the ethics committee. Collaborators signatures will not invalidate the application.