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Research ethics and integrity

Working with the NHS

York St John is proud to work alongside researchers and clinicians in the NHS.

We are committed to supporting new and challenging research and the following resources will help applicants complete their ethics application.

The Integrated Research Application System (IRAS) and insurance forms are required in all cases. However, not all of the forms listed at the end of this page will be needed, and your NHS partner will be able to give you more help and support when completing any necessary forms.

Integrated Research Application System (IRAS)

IRAS is a single system used when applying for the permissions and approvals for health and social care/community care research in the UK.

It is used primarily when working with the NHS but may be used when working with the HM Prison and Probation Service (HMPPS).

Once fully completed this will need to be signed off by the NHS/HMPPS and by the Head of Research Office, on behalf of the University. 

IRAS guidance can be found on the IRAS website.

Insurance documents

The York St John insurers (AON) provide cover for the majority of research undertaken on behalf of the University. When working with the NHS/HMPPS, researchers will need to ensure adequate insurance cover is in place.

Researchers should contact the Research Office (ResearchOffice@yorksj.ac.uk) for help in obtaining additional insurance documents from AON to meet the needs of the project.

Guidance in insurance forms can be found here: Insurance guidance (staff intranet).

Timeline

The process of completing the IRAS form and obtaining approval from your NHS partners and York St John can be lengthy. It may take many months to complete and your research cannot begin until this is in place. Your research plan should therefore take into account possible delays of up to 12 months.

In some cases the NHS and/or York St John may ask you to provide further information, or make amendments to your application before this can be approved. Your form will then need to be re-submitted for approval.

Sign off by York St John

York St John is required to digitally sign the IRAS form. The Pro Vice Chancellor - Research and Knowledge Transfer is the sponsor of any project undertaken by York St John. However the Head of Research Office will digitally sign the form on their behalf.

Additional resources

HRA

Health Research Authority - GDPR transparency wording template to be used by all sponsors.

All sponsors are expected to use the new GDPR transparency wording template for any new research applications submitted via IRAS. This includes the leaflet about the use of confidential data in research, which is designed for patients and participants and provides more technical and detailed information in a layered way.

Gatekeeper documents

A gatekeeper is a person or organisation who acts as an advocate between the researcher and a potential participant. For example, where children are participants, parents may be considered the gatekeepers and they would give their consent on the child's behalf to participate in the study.

These may not be needed in all projects, but where they are, you should submit them alongside your IRAS application.

Organisation Information Document (OID)

This document helps research teams in the hospital to prepare to deliver the research project. It outlines the key information on what is being asked of the hospital to deliver the project. For example, participant groups, nursing time recruitment targets, equipment needs and additional training needs.

There are different templates for the OID. You should use the appropriate template to create an OID for your project.

You can find more details on the IRAS website.

Schedule of Events (SoE)

Completed alongside the IRAS form and details non-commercial research studies. Together with the OID, the IRAS Schedule of Events is designed to facilitate the conversation necessary between the sponsor or their authorised delegate and their participating NHS / HSC organisations, in order to successfully set-up a study.

The IRAS Schedule of Events is designed to allow the sponsor or their authorised delegate to detail the activities to take place at their participating NHS / HSC organisations and to indicate the cost attribution of each activity.

Further information on the SOE can be found on the IRAS website.