Category C - NHS and HSC

Research involving the NHS and/or HSC is regulated by the HRA and various other organisations and legislation. It requires multi-stage applications and often multiple approvals.

Steps have recently been taken by the HRA to streamline the process but it is still relatively complicated and takes time to navigate.

How to apply

The primary system for making an application is Integrated Research Application System (IRAS)

This is web-based and provides the main form for seeking ethical and governance approvals.

You will also need to attach/upload supporting materials and complete additional documentation including a Local Information Pack (LIP) and an Organisational Information Document (OID).

You will also need evidence of sponsorship (institutional support and approval for your study) and insurance.

Research Governance will help you to navigate these processes and provide you with appropriate documentation at the appropriate time.

Apply online with IRAS

Forms & Guidance

Risk Assessment

• RGIc Risk assessment.
• RG1c Guidance

Human Tissue Studies Registration Form

• RG1d Human Tissue Studies Registration Form

Human Research Adverse Events

If something goes wrong in your research you are required to report the adverse event using form RG5.

This form is to report Human Research Adverse Events.

• RG5 Human Research Adverse Events Report Form

You must follow the procedures for dealing with adverse events where appropriate.

If the problem is not related to the conduct of the study, then contact the Research Governance section for advice.

Ethical Review

Applications in Category C which involve patients, clients or service users of the HSC and/or NHS require review by an NHS ethics committee.

The committees for Northern Ireland are managed by ORECNI.

There are also committees across the rest of the UK.

Once your application has been through the peer and filter committee review process, you should contact Research Governance to arrange sponsorship and indemnity and also to obtain approval for submission of your application via the IRAS system.

You will also need to provide documentation to the trust(s) or other organisation which will host your research.

Peer Review

All human research carried out by staff or students of the University requires peer review, primarily to ensure viability, completeness and quality. Peer review should be carried out by individuals who are independent of the study but are qualified to comment on the science or methodology being used.

Peer review might be conducted by University or trust staff (for studies involving HSC/NHS patients) or, in the case of a grant application, by someone appointed by the funding body. The University’s policy and procedures allow Filter Committees to carry out peer review as part of their assessment of a project, subject to workload.

Filter Committees are also expected to maintain a list of people who can be approached to conduct peer review.

You should submit your application (RG1a or IRAS form and associated documents) to an appropriate peer reviewer.

Following review, you will receive an RG2 report form which will detail any changes you need to make and the next steps you need to take.

Filter Committee Reviews

Following the conclusion of the peer review process, your application will require consideration and approval by an appropriate filter committee.

Filter committees are in place across the University to ensure that all areas in which human research takes place are represented. Here you will find a list of contacts (opens to list shown below)

Your application (RG1a or IRAS form, associated documents and the RG2 peer review report form) should be submitted to the appropriate filter committee using the preferred process, which might be manual or electronic.

At the conclusion of the filter committee process, you will receive an RG3 report form which will detail any changes you need to make and the next steps you need to take.

Please note that filter committees will provide approval for Category A research (low risk).

Research in categories B,C and D will require further review by UREC or an NHS/HSC ethics committee.