NHS Research FAQs

Answers to popular questions relating to NHS research projects.

I'm planning to conduct my research in the NHS. How do I get ethical approval?

If your project is research and involves NHS patients, service users, organs, tissue, data or other bodily material, the requirements of the Department of Health Governance Arrangements for Research Ethics Committees (GAFREC) will apply. For specific details of the scope of NHS REC review, see the governance arrangements for research ethics committees.

Not all projects undertaken within the NHS are research. The HRA has two useful decision tools on its webpages to help you to determine whether your project is research and whether it needs NHS REC approval. See Is my study research? and Do I need NHS REC approval? You are advised to seek guidance from the NHS Trust Research and Development Office if, having considered the published guidance, you are unsure whether your project should be classified as research.

How do I apply for NHS REC approval?

You will need to complete the IRAS (Integrated Research Application System) form. Before you begin your application, you must contact Leigh Taylor at researchethics@uwe.ac.uk.

Students requiring NHS REC approval must discuss this with their supervisor.

What is IRAS (Integrated Research Application System)?

IRAS is the Integrated Research Application System. It is a single system for applying for the permissions and approvals for health and social care and community care research in the UK. IRAS FAQs are available on the IRAS help pages.

Do I need the NHS Trust Research and Development approval?

If your research involves undertaking the research on the premises of an NHS organisation, with NHS patients or with NHS staff, then you should contact the local NHS Trust Research and Development office (see NHS/HSC Research and Development review or permission) as you will need permission from the relevant NHS Trust Research and Development office before access to these are approved.

Note: You will need to obtain FREC ethics approval for your research in addition to this permission.

What is a Research Passport and how do I apply for one?

The Research Passport is a mechanism for pre-engagement information about a researcher to be shared with relevant NHS organisations in which the applicant intends to conduct research. It includes an occupational health assessment, employment/student screening and DBS check.

Human Resources deal with Research Passport applications for all members of staff, contact hr@uwe.ac.uk. Student applications for all faculties are handled by Leigh Taylor.

Please note: If you are a PhD student and also a member of staff (i.e. you have a contract of employment with UWE Bristol), your Research Passport application will be handled by Human Resources. All other PhD students, e.g. those who are self-funded, bursary-funded or sponsored by an employer, should contact Leigh Taylor who will deal with your Research Passport application.

My research participants include vulnerable adults. What ethical approval do I need?

Under the Mental Capacity Act 2005, social care research, i.e. involving people lacking capacity in England and Wales, requires approval from the National Social Care REC or NHS REC.

The Research Ethics Service has flagged a number of NHS RECs in England and Wales to review new applications for approval under the Mental Capacity Act (MCA). Members of these RECs have had additional training in issues relating to the MCA.

Applications should be booked with the Central Booking Service so they can be allocated to an appropriate REC.

The application form, available via the IRAS, incorporates specific questions about compliance with the Act in Part B Section 6 of the form.

Does the Mental Capacity Act apply only to research ‘in or with’ the NHS?

The Act applies to any intrusive research within England and Wales, wherever it takes place, except for clinical trials of investigational medicinal products. This may include research in health, social care, criminal justice and many other settings. It is not limited to research undertaken within NHS organisations or other public bodies.

Do projects that are not classified as research require approval under the Mental Capacity Act?

No. The provisions of Sections 30-34 of the Act apply only to studies that are designed and presented as research. It is the responsibility of the researchers’ employers or sponsors/funders to determine whether a project should be presented as research.

What is a research sponsor?

The Research Sponsor takes ultimate responsibility for the conduct and integrity of the research, ensuring that research projects have adequate indemnity/insurance arrangements, are registered, are approved by the appropriate bodies and are subsequently monitored.

Who acts as a research sponsor?

UWE Bristol will normally act as research sponsor for research conducted by its staff and students. However, there are circumstances when this may not automatically apply – see guidance.

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