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, particularly when the research involves more than one of the UK nations, and it takes time to navigate.

The main steps are:

1. Sponsor internal processes
2. Submission for Study-wide Governance Approval and Research Ethics Approval using a single application form
3. HSC and/or NHS site set-up and Capacity and Capability confirmation and permission from each research site, and / or any non-NHS/HSC site permissions
4. Sponsor greenlight

Certain studies (for example those involving HSC/NHS staff only) are exempt from requiring ethical review by an HRA REC, however these will still require internal review by an Ulster University Filter Committee as well as HSC/NHS site approval. Filter Committees will, in all cases, review the IRAS application form.

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

Sponsorship

In the UK it is a mandatory requirement for all health and social care research governed by the UK Policy Framework for Health and Social Care to have a sponsor. This is the individual, organisation or partnership that takes on overall legal and governance responsibility for proportionate, effective arrangements being in place to set up, run and report a research project.

The sponsor is normally expected to be the employer of the chief investigator in the case of non-commercial research or the funder in the case of commercial research. The sponsor has overall responsibility for the research, including:

a) the quality of the research design, protocols, and application

b) suitability of the investigators, research team and research sites

c) agreement and documentation of the roles and responsibilities of the parties involved in the research and any delegation

d) adequate provision for insurance or indemnity to cover liabilities which may arise in relation to the design, management and conduct of the research project

e) arrangements made for making information about the research publicly available before it starts; arrangements for making data and tissue accessible, with adequate consent and privacy safeguards after it has finished; arrangements for information about the findings of the research to be made available, including to participants

f) approval from a Research Ethics Committee and any other relevant approval bodies is in place before the research begins

g) the regulatory and practical arrangements before permitting the research to begin in a safe and timely manner

h) adequate finance and management of the research project, including its competent risk management and data management

i) procedures and adherence for reporting (e.g. progress reports, safety reports) and for monitoring the research, including its conduct and the ongoing suitability of the approved proposal or protocol in light of adverse events or other developments.

How to apply for sponsorship

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.