Guidance for IRAS applications

The National Research Ethics Service (NRES) oversees the overall structure and operation of research ethics governance across the UK. Local Research Ethics Committees (LRECs) across the UK serve specific regions and are responsible for reviewing research projects. Multi-Centre Research Ethics Committees (MRECs) review large-scale multi-centre clinical research projects.

Ethical approval from the appropriate NHS REC is required for any research proposal involving NHS resources or any clinical trial of a medicinal product under the Medicines for Human Use (Clinical Trials) Regulations 2004. In the UK, it is against the law, under the Medicines for Human Use (Clinical Trials) Regulations 2004, to start, recruit for or conduct a clinical trial of an investigational medicinal product (CTIMP) until there is a favourable opinion from a recognised REC (and authorisation from the licensing authority–the Medicines and Healthcare Products Regulatory Agency, MHRA).

It is the responsibility of the Chief Investigator (CI) with supervisors/research teams to ascertain whether the study is indeed a clinical trial. If clarification is still required for the category of the study, the PI should contact a research ethics committee. NHS REC ethics approval is needed for clinical trials of investigational medicinal products (CTIMPs), for healthy volunteer studies (CTIMPs) Type 1 REC approval should be sought. For gene therapy trials (GTAC) approval should be obtained. For all other healthcare research within the NHS, you will need to apply for ethics review via the NHS REC system. For overseas projects, you will need to ensure that you are aware of and comply with local ethics approval systems which can vary significantly.

NHS IRAS/REC have developed a fast-track approval process with information about it on this link. The link includes a validation checklist to self-evaluate the completeness of the application before submission.