Is it research?
Researchers are advised to use the following decision tools provided by the Health Research Authority (HRA):
What permissions do I need?
The permissions or approvals required will depend on the type of research you are undertaking.
Permissions include (list not exhaustive):
- NHS R&D approval
- NHS Research Ethics Committee — certain types of research will not require REC review as per GAfREC guidelines
- NIHR Portfolio Adoption
- Medicines and Healthcare Products Regulatory Authority (MHRA) — for both CTIMP and Medical Device studies see the Medicines and Healthcare Products Regulatory Agency website.
For general information on all of the above permissions see the NHS management permission website.
Applying for approvals
Most applications to regulatory review bodies can be made via the Integrated Research Application System (IRAS) and will require you to set up an account.
IRAS was developed to bring all the research regulatory application forms together in one place. By completing a checklist of questions, the system will generate the forms you need to complete based upon your responses including the:
- Portfolio Adoption Form (PAF)
- Research Ethics Committee (REC) Form
- Research & Development (R&D) Form
- Site Specific Information (SSI) Form
- MHRA Form
An IRAS training module is available (approx. 60 minutes) that will lead you through the system and show you how all of the forms are generated. It also explains how certain information is pre-populated throughout the form to save having to repeat certain text. Read up on some top tips for using IRAS.
Sponsorship and Peer Review
What is a sponsor?
A sponsor is an organisation (or group of organisations) that accepts responsibility for ensuring that there are proper arrangements to initiate, manage, monitor and finance a project. The NHS Research Governance Framework requires that all research taking place in an NHS or social care context must have sponsor.
An electronic signature is required in IRAS from the sponsor representative before submission.
A request for HEY to act as sponsor can be made by emailing a copy of the research protocol (if you have one), a Sponsorship Request Form and any other available information to: firstname.lastname@example.org including “Sponsorship Request” in the subject line.
A request for HEY to act as sponsor for a Clinical Trial of an Investigational Medicinal Product (CTIMP) should also follow the Request for Sponsorship and HEY R&D approval for HEY-sponsored CTIMPs.
After receiving the completed Sponsorship Request Form and a good draft of the protocol, we will then hold an Investigator/Sponsor meeting and will confirm to you if we are happy to sponsor the study or if there are any issues to resolve.
For further guidance on developing a research protocol, there is a very useful HRA protocol guide and template. This is very comprehensive and contains all the sections to include.
Peer review is when a research proposal or protocol is scrutinised by independent experts to promote quality research and prevent poorly designed research from taking place. While the Research Governance Framework places responsibility for assuring the quality of research through peer review to the funder, this will sometimes be undertaken by the sponsor (if they are not the same organisation).
The R&D Office may require confirmation of peer review and in certain circumstances an independent peer review will be carried out.
Make early contact with R&D
If you have a research idea or proposal that you wish the Trust to support, please make contact with the R&D Office at the earliest opportunity and someone will talk you through the R&D approval and sponsorship process.