Obtaining ethics approval

Any health-related research project which involves humans, their tissue and/or data must be reviewed and approved by a Research Ethics Committee prior to the start of the study (including any advertising for study recruitment). Please note that only certain student projects below PhD level are able to gain approvals via the HRA and NHS REC approval, please see the HRA student research website for further details.

This section details which projects require ethics approval, and the bodies and committees you need to apply to.

• For research that involves NHS staff, premises, patients and or their data, including

• 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)
• Potential participants identified because of their status as relatives and or carers of patients and users of the NHS
• Access to data, organs or other bodily material of past and present NHS patients
• Foetal material and IVF involving NHS patients
• Recently deceased in NHS premises
• Use of or access to NHS premises or facilities
• NHS staff recruited due to their professional role
• Healthy volunteers where a drug or device is being tested within the NHS

You should apply for Health Research Authority (HRA) Research Ethics Committee (REC) approval through the Integrated Research Application System (IRAS). These types of study would include:

• a Clinical Trial of an Investigational Medicinal Product (CTIMP) (with the exception of Phase 1 trials in healthy volunteers taking place outside the NHS)
• 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 guidance can be found on the HRA REC approval process page.

• Non-NHS health research involving human participants and or their data (aside from that which falls under the remit of HRA REC) with the primary aim of answering a human health related question is the responsibility of Imperial College Research Ethics Committee (ICREC)
• Research involving human participants and or their data (aside from that which falls under the remit of HRA REC) with the primary aim of answering a science, engineering or technology related question should be submitted to the Science, Engineering and Technology Research Ethics Committee (SETREC)

• 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. 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.

It should be noted that additional licences and/or approvals are required for some types of study and these are detailed on the Routes to ethics approval page. If you are unsure whether your project requires ethical approval you are strongly advised to contact the RGIT (previously JRCO) or a relevant Ethics Committee.

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 be conducted 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.

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