Category B - Higher risk research

The approval route for research in Category B is internal to the University.

While it is unlikely to be governed by legislation or regulation, it is likely to be of a higher level of risk.

This might include dietary, psychological or other interventions, lone working and/or data collection in higher risk environments including overseas, studies in schools or with children in other environments, studies with people supported by charitable organisations, studies with the elderly.

How to apply

Applications for Category B research should be made using the University's RG1a form.

RG1a is an application form to undertake research on human subjects.

• RG1a Application to undertake research on human subjects
• RG1a Guidance Notes on Completion of Form RG1a

Other forms you might need

There are other forms listed below which may be required under this category of research.

Risk Assessment

• RGIc Risk assessment.
• RG1c Guidance

Checklist for submissions to UREC

The RG1e checklist must accompany all other documents being submitted to UREC for review.

• RG1e checklist to undertake research on human subjects

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.

Substantial Amendment to Approved Research

If you want to make an amendment to a study that has already been approved you will need to follow the amendment process by completing a RG6 form.

There are 2 methods of submitting a RG6. Please read the guidance document to determine which method you must use.

• RG6 Guidance
• RG6 form Word document version (for non-REMS submissions only – see guidance before use)

Application submission dates for categories B & D UREC submissions

Please note that late submissions will not be accepted

• Friday 17 January 2025 for meeting on Monday 3 February 2025
• Friday 21 February 2025 for meeting on Tuesday 11 March 2025
• Monday 24 March 2025 for meeting on Thursday 10 April 2025
• Tuesday 29 April 2025 for meeting on Friday 16 May 2025
• Friday 30 May 2025 for meeting on Wednesday 18 June 2025
• Friday 18 July 2025 for meeting on Tuesday 5 August 2025

Read our guidance on how to submit an application to UREC

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.