Advice and guidance on getting ethical approval from a research ethics committee

The role of Research Ethics Committees (RECs) is to ensure that the dignity, rights, safety and well-being of research participants are preserved.

Any study that involves access to past or present medical records of NHS patients, service users, care professionals or volunteers, or data, tissue or NHS facilities, may require ethical approval. Research projects must not start until this approval has been secured from an NHS Research Ethics Committee.

However, if your project falls under the category of audit or service evaluation, you do not require NHS REC approval. A full list of studies which do not require REC approval can be found on the HRA website:

• Research requiring NHS RD review but not ethical review

For case note review projects which involve anonymised data only these generally do not require NHS REC approval. However, these projects still need to be registered with the R&D Office and reviewed for R&D approval. During the review process the researcher will be asked to complete the online HRA tools to confirm the project does not require NHS REC approval.

There are two different types of NHS RECs: recognised and authorised. Recognised RECs are recognised for their review of Clinical Trials of Investigational Medicinal Products (CTIMPs), though they may also review non-CTIMP trials. Authorised RECs can review all applications bar CTIMP trials.

Your study may not need to go to an NHS Research Ethics Committee, but it may require review by the UCL university ethics committee if you are a student researcher or UCL staff. Please contact the Joint GOSH/ICH R&D Office for more information at Research.Governance@gosh.nhs.uk 

For research involving children it is recommended, but not obligatory, that you book your application with a flagged REC. The research governance team can advise you on flagged RECs based in London. The London Bloomsbury REC hold their meetings locally and are flagged to review research involving children and recognised to review type III CTIMPs in patients.

Applications for ethical review by RECs are made using the Integrated Research Application System (IRAS) at https://www.myresearchproject.org.uk  - If you are using IRAS for the first time, you will need to register your details, create your project and then start completing the IRAS project filter form. If you are unsure of anything, please feel to contact the R&D Office for guidance.

All applications to a REC must enclose:

• IRAS checklist
• Signed IRAS application
• Research protocol
• Summary CV for the Chief Investigator
• Participant information sheets and consent forms
• Evidence of insurance or indemnity (for non-NHS sponsors only)

Other documents may also be necessary and will be outlined in the IRAS checklist. The IRAS application and checklist are downloaded from IRAS.

Steps on how to apply and book a meeting with a REC can be found on the HRA website:

• HRA guidance – Applying to a Research Ethics Committee

The REC is required to give an ethical opinion within 60 calendar days of the receipt of a valid application. The REC will issue a formal letter to the CI with their opinion. Only once the REC has approved the study and all other governance checks have been fulfilled will you be able to proceed with your research project.

Guidance on completing the IRAS application form and supporting documentation is available on the IRAS website – when completing IRAS forms online there are green ‘i’ symbols next to some sections – these will provide you with extra information about how to answer the question. Specific queries relating to the application form or process of ethical review can be raised with the research governance team: Research.Governance@gosh.nhs.uk