Getting started with ethical reviews

When do I need an ethical review?

All studies that involve human participants, their tissue and/or data should undergo an ethical review.

If your study does not involve human participants or their data/tissue it will not require an ethical review unless it raises some other significant ethical concern and you have been directed to seek an ethical opinion. 

If you have any questions or are in doubt, please email research-governance@bristol.ac.uk.

External reviews

The following cases require review by one or more external bodies, you will need to apply via the Integrated Research Application System (IRAS).

If any of the following criteria apply to your study, please start by completing the Research Registration Checklist (Redirects to Microsoft Forms – form usually takes around five minutes to complete).

Study requiring access to NHS facilities and / or use of NHS time or resources

In this case, a Health Research Authority (HRA) review will be needed. If your study meets this, but none of the other following categories, it will also require a University ethics review.

Study in which participants are identified due to their being NHS patients or service users

This also applies to research using NHS data or data generated in relation to NHS services or diagnoses.

An NHS Research Ethics Committee (REC) review will be required. If you are unsure whether your project involves relevant NHS activity, please see the Health Research Authority's Do I need NHS REC review? decision tool.

Study involving the analysis or storage of ‘relevant material’ under the Human Tissue Act

An NHS REC review will be required.

An investigation into the safety and/or efficacy of a medicinal product

Research of this nature requires review by an NHS REC and by the Medicines and Healthcare products Regulatory Agency (MHRA).

Study intended to generate data to support the licencing or marketing of a medical device

An NHS REC review and MHRA review will be required. Note: this does not apply to all research involving medical devices – the distinction is not always immediately apparent. If you think that your study may fall into this category, contact research-governance@bristol.ac.uk as early as possible.

Research involving participants in social care who lack capacity to consent

This study category requires a review by an NHS REC specialising in social care.

Research involving participants in social care

This type of study may require review by an NHS REC specialising in social care. Please contact research-governance@bristol.ac.uk to discuss the details.

Research involving participants identified due to their being currently in prison or on parole

This type of study requires review by Her Majesty's Prison and Parole Service (HMPPS).

If you are still unsure about the type of ethical review that is required please contact research-governance@bristol.ac.uk.

University REC review

If none of the external review criteria apply, in most cases a University ethics review will be carried out by your School or Faculty Research Ethics Committee.

Please apply via the Online Research Ethics Management System (OREMS) unless your school has not yet adopted this system, in which case you should use their process.

Additional information

Not all projects fall within the NHS definition of research. If you are unsure whether you are instead proposing an Audit or Service Evaluation (which will not require REC review), you can find further guidance via the Health Research Authority's Is my study research? decision tool.

For more information about ethics reviews and accompanying policy and procedure see our Research Governance and Integrity Policy (PDF, 240kB).