Getting your NHS research project approved: A generic guide for researchers

All research involving the NHS requires approval before you can start to conduct your study. This summary gives a guide about which approvals are needed, what documents you need to prepare, and tips for ensuring a smooth approval process.

Basic Approval Information

Depending on the kind of research you wish to conduct, you may need one or several of the following approvals:

- NHS Ethics Approval - Medicines and Healthcare Regulatory Authority (MHRA) Approval

- NSFT/ NHS Trust Research Approval - Human Tissue Authority (HTA) Approval

Additional approvals may also be needed, depending on the study and how you wish to undertake it. The most common two approvals required are:-

- NHS Ethics Approvals

Most research in the NHS requires an NHS Ethical Approval, provided through the national Health Research Authority. Only one NHS Ethics approval is required per study, regardless of how many NHS organisations you plan to involve.

- NSFT & NHS Trust Research Approvals

All research undertaken with NSFT service users, carers, staff, data or on NSFT premises requires NSFT Research Approval (otherwise known as R&D approval or Research Governance Approval). This is entirely separate to Ethics approval, as it concentrates on assessing the feasibility and risks of delivering the study practically within the Trust.

If you plan to conduct your research in more than one NHS organisation, then you will need to gain approval from each participating NHS site, as local feasibility and considerations are different in each organisation, however the submission process for each is the same.

Timelines

Be aware that gaining approvals to conduct research in the NHS is unlikely to happen within a few days. Depending on the complexity of your project, ethical issues raised, and the number of sites that you wish to visit, then approvals can take weeks to months. Informing NSFT as soon as possible regarding your study could dramatically reduce the amount of time taken to approve the study.

How to apply for Ethical and R&D Approval

All applications for approval in the NHS are required to be completed in the Integrated Research Application System, otherwise known as IRAS. This is a web-based application system from which applications for Ethics and NSFT approval are completed within a single integrated dataset. IRAS can be accessed here (free registration required): www.myresearchproject.org.uk

In addition to completing the application forms, you will need the following documents:

·  A well-written protocol

·  Patient Information Sheets/Consent Form

·  Any other documentation given to prospective participants and/or clinicians i.e. Posters, flyers etc.

·  A copy of any questionnaires or interview schedules to be undertaken in the research.

·  Researcher CVs.

·  Evidence that the clinical area/service that you are involving has been consulted and is happy to take part i.e. email confirmation or signature on the application forms.

The Research Office is more than happy to meet with you to go through the IRAS form and check that everything has been completed correctly. Training to use IRAS is also available. Please email to arrange an appointment.

NSFT Approval process

As soon as we receive your application we begin a local governance review. During this process we are required to conduct a number of checks set nationally by the National Institute for Health Research through their governance criteria. The procedure we follow depends if your study is a Portfolio or Non-Portfolio study.

Research Training

If your research involves actively recruiting participants from the NSFT, then you should have a valid Good Clinical Practice (GCP) certificate. To obtain the certificate, you will need to attend a GCP Training course or complete an online course. Course and booking details are available through the Research Office. GCP training should be refreshed every 24 months to remain valid. Other courses are available through NSFT Research to help manage your study after approvals.

Useful Links and Information:

NHS Health Research Authority – http://www.hra.nhs.uk/research-community/applying-for-approvals/

NSFT Research Procedure: 2 – Generic Guide to Approvals. V1 Aug14