Information for researchers

Whether you are setting up your own study or want to participate in an existing study, the Research Team at St Mary’s Hospital are here to help support you with every aspect of the research process and to help with any queries or issues there may be.

IRAS (Integrated Research Application System)

IRAS is a single system for applying for the permissions and approvals for health and social care / community care research in the UK and captures the information needed for the relevant approvals from the following review bodies:

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Gene Therapy Advisory Committee (GTAC)
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS / HSC R&D offices
• NRES/ NHS / HSC Research Ethics Committees
• Confidentiality Advisory Group (CAG), formerly the National Information Governance Board (NIGB)
• National Offender Management Service (NOMS)
• Social Care Research Ethics Committee

If you are a first time user of the Integrated Research Application System, you will need to create a "New User" Account.

National Research Ethics Service

The Health Research Authority is responsible for Research Ethics Committees (RECs) and their website provides a valuable and useful resource when setting up your study.  For details of your local REC office within the South Central Region and meetings dates for the forthcoming year, please click here 

Sponsorship 

Every research project requires a Sponsor and their role is to take overall responsibility for the management and monitoring of the study.  Normally, the sponsor will be one of the organisations taking the lead for particular aspects of the arrangements for the study, such as the Chief Investigator’s employing organisation, the lead organisation providing health or social care, or the main funder (eg a University, Pharmaceutical Company or a NHS Trust).

The Isle of Wight NHSTrust may be willing to act as the sponsor for research that does not have an external sponsor (sometimes called “own account” research).  If you would like the Trust to sponsor your study, please contact the Research Department.

How to apply for Isle of Wight NHS Trust R&D Approval

Written permission must be obtained from the Research Department before any research starts.

Every study, including service evaluation projects, is considered by the Trust’s Research & Development Committee, which meets bi-monthly.

To complete and submit your submission to the R&D Office for approval, please refer to IRAS Checklists 1, 2, 5 and 6 for a list of documents that we will require to process your application, depending on whether your study is a CTIMP (Clinical Trial of a Medicinal Product) or not.

All documents would need to be dated and/or have version numbers and these can be sent electronically by email to:  sarah.knight2@iow.nhs.uk

or by post to:  Research Dept, South Block, St Marys Hospital, Newport, Isle of Wight, PO30 5TG

COMMERCIAL RESEARCH

The Trust is keen to develop and expand its commercial involvement across the specialties.  The contribution of departments and individuals to commercial studies is recognised by a distribution of the income generated in line with NIHR good practice guidance Income Distribution from NIHR CRN Industry Portfolio Studies 

Currently, not all commercial research is directly hosted by the Trust.  Vectasearch Clinic Limited is a private company established in 1991 which operates from a building on the St Mary's Hospital site.  Most commercial research conducted at St Mary's Hospital site is hosted through Vectasearch Clinic Limited which has “NHS site” status with the National Research Ethics Service.  However, they do not have their own in-house research management and governance service.  Therefore all research which is conducted through Vectasearch involving NHS patients, recruited via NHS clinics, is reviewed by the Research Department and NHS permission (R&D approval) is given before any study can commence recruitment.

Research Training:

A key requirement for anyone involved in the conduct of clinical research is Good Clinical Practice (GCP) training.  All research active professionals participating in research are required to undertake GCP training before commencement of recruitment for CTIMPs (clinical trials of investigational medicinal products) and within 6 months of R&D approval for all other studies (non-CTIMPs).  This training is to be refreshed every two years for those who remain research active.  Please contact the Research Department for details of training available.