R&D Approval
To enable Salford Royal NHS Foundation Trust to act as Research Sponsor for the study, the PI must fill in a sponsor arrangement form. This can be downloaded here
When carrying out studies in NHS organisations, approval needs to be obtained from various sources before the study can proceed. It is a common misconception that only approval from the Research Ethics Committee needs to be obtained. In many cases R&D Approval is required and also approval from participating Universities. It is therefore good practice to contact the relevant R&D Departments to ask what documentation they require.
We have put together an R&D Application Pack pack containing information and guidance on carrying out research studies involving Salford Royal and also ReGrouP. ReGrouP covers the 10 Greater Manchester Primary Care Trusts and is hosted by Salford Royal Foundation Trust. For further information regarding ReGrouP please follow the GMPC logo at the bottom of the page.
To download a copy of the Research Governance Checklist Click Here
Any queries on new studies, or general enquiries, please phone our new helpline on 0161 206 8343. Alternatively, Click Here to get in touch via Email
IRAS
IRAS was updated to Version 2.1 to include the full EudraCT application form on 9 March. This allows applications forms and xml files for authorisation of clinical trials of investigational medicinal products to be created from IRAS for the MHRA. You can choose whether to update existing projects to Version 2.1 if relevant to your project. Please refer to the Updates page in Help for further information.
The 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
- Enables you to enter the information about your project once instead of duplicating information in separate application forms
- Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
- Helps you to meet regulatory and governance requirements
- Retains familiar aspects of the NRES form system
IRAS 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)
- Ministry of Justice
- NHS / HSC R&D offices
- NRES/ NHS / HSC Research Ethics Committees
- Patient Information Advisory Group (PIAG)
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A number of upgrades to IRAS have already been made to develop the system. The first stage was to provide a mechanism to import and export data on Investigational Medicinal Products between EudraCT and IRAS for applications to MHRA Medicines. In November 2008 IRAS became the entry point for the National Institute for Health Research Coordinated System for gaining NHS Permission (NIHR CSP). Version 2.0 was released in December 2008 and incorporated a number of improvements to guidance and functionality, including electronic authorisations, in response to feedback from users and review bodies during the consultation-in-use phase. Further details about updates and future plans are available on the Updates page in the Help section.
Applicants should note that projects already set up in the NRES form system can still be accessed and used to submit amendments or additional sites through the NRES form system.
For More Information, Please Click Here
We encourage further feedback. This can be sent to iras@nres.npsa.nhs.uk. This feedback will be included in the next review.
IRAS e-learning Module
An online module has been added to IRAS to guide new users through IRAS. The module, which is free, explains how IRAS is structured and guides users through how to prepare and make applications using IRAS. See https://www.myresearchproject.org.uk/elearning/
