Any health related research project which involves humans, their tissue and/or data must be reviewed by a REC prior to it commencing. This applies whether the project is to be externally or internally funded and/or whether the project is to be conducted in the UK or overseas.

A REC will review the research protocol and other relevant project documentation to provide an assurance that the dignity, rights, safety and well-being of research subjects will be protected in a research study.

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). Research within the NHS requires ethics approval from the National Research Ethics Service this could involve:

  1. NHS patients or service users (including potential participants recruited by the patient or user’s past or present treatment and NHS patients treated under contracts with private sector institutions)
  2. Potential participants identified because of their status as relatives and or carers of patients and users of the NHS
  3. Access to data, organs or other bodily material of past and present NHS patients
  4. Foetal material and IVF involving NHS patients
  5. Recently deceased in NHS premises
  6. Use of or access to NHS premises or facilities
  7. NHS staff recruited due to their professional role
  8. Healthy volunteers where a drug or device is being tested within the NHS

Similar local regulations and requirements are in place in other countries across the world.

If you are unsure whether your project requires ethical approval you are strongly advised to contact the JRCO or a relevant Ethics Committee in order to cover yourself.

Responsibilities

It is the responsibility of the Principal Investigator to ensure that a health-related research project has been reviewed by a REC. If a project is to occur in the UK the Principal Investigator must be professionally based in the UK.

Project specific

Ethics approval is project-specific. A research project which has separate protocols governing one or more sub-studies in addition to the main study should have a separate ethics review for each protocol.

Routes to ethics approval

The route for applying for ethics approval for your project will differ depending on where your research is to be conducted and the specific nature of your study; whether it is a clinical trial of an investigational medicinal product (CTIMP), involves gene therapy or is a human tissue/epidemiological study.

The information below is primarily focused on research occurring within the UK and therefore governed by UK law. For international studies an ethics application must always be made to a REC in each country in which the study is to be conducted, whether or not the project already has a favourable ethical opinion from another REC outside a particular country.

UK based projects

CTIMPs in patients

Any phase

Ethics approval should be sought via the HRA REC system. 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 - which must be submitted  with your  ethics application.

CTIMPs in healthy volunteers

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. A Type 1 REC local to Imperial College is Riverside Ethics Committee. You also need to register your project with the JRCO.

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 - which must be submitted  with your  ethics application.

Gene Therapy

Ethics approval should be sought from the Gene Therapy Advisory Committee (GTAC) instead of an NHS REC.

However, you will still need to seek a favourable Site-Specific Assessment (SSA) from the local NHS REC for each site where the research is to take place using Part C of the NHS REC application form (once GTAC have acknowledged your valid application).

Health-related NHS projects

within the NHS (non-CTIMP)

Ethics approval must be sought for all healthcare research within the NHS. You will need to apply for ethics review via the IRAS system. Further information can be found under ethics approval in the SOPs section.

Health related non NHS projects

For those projects which fall outside the remit of the IRAS system, 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 the project will have no UK component e.g. if their regulatory environment is not well-developed.  

ethics approval

Non CE/ CE marked medical device

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

Human embryonic stem cell

You will need to apply for a licence from the HFEA (Human Fertilisation and Embryology Authority). This should usually be after ethics approval has been received.

Identifiable Patient Information

(Without consent)

You will need to apply to the Confidentiality Advisory Group (CAG) for approval for your project. You should usually submit this after you have received a favourable opinion from an NHS REC.

Overseas projects (including EU)

The process of ethical review 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 the ICREC can be approached.

For further information please contact one of our Research Governance Managers who can provide you with specific advice.