Routes to ethics approval

In the UK it is against the law under the Medicines for Human Use (Clinical Trials) Regulations 2004 to start, recruit to 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).

For trials of any phase, ethics approval should be sought via the HRA REC system. REC will communicate internally with HRA if your research involves an Investigational Medicinal Product you need to apply for a Clinical Trial Authorisation (CTA) from the MHRA. This should usually be at the same time as you make your ethics application - although final ethics approval is conditional on receiving MHRA approval.  

You also need to apply for a EudraCT number. The EudraCT number is a unique identifier for your trial and should be on protocol and IRAS form.

In the UK it is against the law under the Medicines for Human Use (Clinical Trials) Regulations 2004 to start, recruit to 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).

Phase 1

Ethics approval should be sought from what is known as a Type 1 REC, which might be an NHS REC or a private committee. There are many committees specialised in Phase 1 healthy volunteer’s trial review. The information can be obtained via HRA website.

 You also need to register your project with the RGI team.

If your research involves an Investigational Medicinal product you will need to apply for a Clinical Trial Authorisation (CTA) from the MHRA. This should usually be at the same time as you make your ethics application - although final ethics approval is conditional on receiving MHRA approval.

You also need to apply for a EudraCT number. The EudraCT number is a unique identifier for your trial and should be on protocol and IRAS form

Ethics approval should be sought from the Gene Therapy Advisory Committee (GTAC). GTAC is the UK national REC for gene therapy clinical research according to regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004. All gene therapy and cell therapy applications for Clinical Trials Authorisation will be assessed by the MHRA and, where appropriate will now be submitted to the MHRA Clinical Trials Expert Advisory Group for review. This review will assure the RECs that appropriate scrutiny of the safety of the application has been carried out. 

The REC will raise any concerns directly with the MHRA.

There are only 4 REC Committee which are specialised in Gene Therapy trial review

• London – West London and GTAC
• South Central – Oxford A
• North East – York
• Scotland A REC

Ethics approval must be sought for all healthcare research within the NHS. This means if you are using NHS staff, premises, equipment, data, you need a REC approval and HRA approval letter.  You will need to apply for ethics review via the IRAS system. This includes the following types of study:

• a Clinical Trial of an Investigational Medicinal Product (CTIMP)
• a Clinical Investigation or other study of a Medical Device
• a combined trial of an Investigational Medicinal Product and an Investigational Medical Device
• a Clinical Trial to study a novel intervention or randomised Clinical Trial to compare interventions in clinical practice
• a basic science study involving procedures with human participants
• a study administering questionnaires/interviews for quantitative analysis, or using mixed qualitative/quantitative methodology
• a study involving qualitative methods only
• a study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
• a study limited to working with data (specific project only)

Further information can be found in the Standard Operating procedures document: SOP/003 NHS REC applications‌

For those projects which fall outside the remit of the IRAS system, i.e. if the  research doesn’t involve NHS staff, premises, patients and or their data, then ethics approval could be sought from the Imperial College Research Ethics Committee (ICREC). Certain countries may require that UK ethics approval is obtained even if the project will have no UK component e.g. if their regulatory environment is not well-developed.

Research unrelated to healthcare, involving human participants or their data will be reviewed by the Science, Engineering and Technology Research Ethics Committee (SETREC). Review of non-healthcare research projects to be carried out by College staff or students (under the supervision of College staff) require ethics approval with the exception of:

• They fall under the remit of ICREC (Health), the NHS, Clinical Trial Regulations on human subjects, tissues or health related databases of personal information. 
• They solely involve animal subjects.
• Are a low risk education project.

You will need to submit a clinical investigation application to the MHRA and receive a ‘notice of no objection’. This should usually be at the same time as you make your ethics application – although final ethics approval will be conditional on receiving MHRA approval. You will need to submit a clinical investigation application to the MHRA and receive a ‘notice of no objection’. This should usually be at the same time as you make your ethics application – although final ethics approval will be conditional on receiving MHRA approval.

A licence must be obtained from the Human Fertilisation and Embryology Authority (HFEA) if your research involves the creation of embryos in vitro and/or storing or using embryos (as stipulated in Human Fertilisation and Embryology Act 2008).

Importantly if your research is of this kind, it must relate to one or more of the following purposes (as stipulated in the Human Fertilisation and Embryology Act 2008).

• To promote advances in the treatment of infertility
• To increase knowledge about the causes of congenital diseases
• To increase knowledge about the cause of miscarriage
• To develop more effective techniques of contraception
• The detection of genetic or chromosomal abnormalities before implantation
• To increase knowledge about the development of embryos
• To increase knowledge about serious disease

The HFEA recommends that you seek ethics approval before applying to the HFEA to ensure the licence covers the approved research activity.  However, you can obviously discuss your licence application with the HFEA at any stage – the JRCO recommend doing so as early as possible as licence approval can take up to 3 months (approx).

You need to contact the HFEA to discuss your licence application and then complete and submit the application form to the HFEA Regulation Department with an administration fee. The HFEA Regulation Department will then initiate peer review of your application and you will receive formal confirmation of the decision.

For more information please visit the HFEA website.

If patient identifiable information will be accessed outside of the direct care team without consent being in place then yYou will need to apply to the Confidentiality Advisory Group (CAG) for approval for your project. You can submit this in parallel with your application for NHS REC approval

Research involving animals falls under the remit of Imperial’s Animal Welfare and Ethical Review Body (AWERB). Further information is available on the Regulation and oversight of animal research page.

If the project is educational research or an educational review/evaluation that you may want to publish - this should be reviewed by (EERP) Education Ethics Review Process  for more information  please visit The EERP process page

The process of ethical review for projects to be conducted overseas is not always straightforward. It is essential that local ethics approval systems are complied with and these can vary.

Certain countries may require that UK ethics approval is obtained even if the project has no UK component particularly countries where their regulatory environment is not well developed. If Imperial is sponsoring your research then ICREC or SETREC can be approached. If unsure please contact the RGIT.