Applications for NHS REC approval can be made online via the Integrated Research Application System (IRAS). This system streamlines the process for seeking relevant approvals by ensuring that, as far as possible, details only need to be entered once for a single project and much of the form then self-populated.
All IRAS applications must be formally sponsored. LJMU will consider sponsoring LJMU staff research projects where the chief investigator is a LJMU employee and LJMU student research projects where the chief investigator or academic supervisor is a LJMU employee. Investigators should allow at least 15 working days for sponsor review. If documents are resubmitted in response to deferral comments, investigators should allow at least 10 working days for the documents to be further reviewed.
Please use the following documents:
For LJMU to confirm sponsorship authorization, please email the following to sponsor@ljmu.ac.uk:
- For student research, email confirmation that the student has completed the LJMU Research Ethics Training
- Email confirmation as applicable from the chief investigator, academic supervisor, lead medical physics expert, lead clinical radiation expert that they have authorized the IRAS form.
Summary CV for Chief Investigator (CI)
- PDF copy of the completed IRAS form
- Study protocol (based on TEM001 Research Protocol Template for IRAS Application)
- Validated questionnaires / Non-validated questionnaires / Interview schedule
- Participant facing documents (information sheets, consent forms, participant recruitment material etc.)
- Evidence of Sponsor insurance or indemnity
Once you have received confirmation of LJMU sponsorship approval the Central Booking Service should be contacted to arrange NHS REC review. It is highly recommended that you arrange a time when you can attend, to answer any queries the NHS REC may have. Students must be accompanied by their supervisor at NHS REC committee meetings.
When the booking process is completed, you will be given the name of the NHS REC, a NHS REC reference number and a submission date. The application should be submitted to the NHS REC the same day of making the booking.
At the meeting of the NHS REC, between 7 and 18 members will be present and will ask questions surrounding any ethical issues arising from your application. You should be prepared to clarify any ethical issues that may be raised.
NHS REC ethical approval is not required for any non-substantial amendments.
Further NHS REC ethical review is required for any substantial amendment. Substantial amendments should be notified using a Notice of Substantial Amendment Form. These forms are generated in IRAS by navigating to the Amendments tab of your project form, and clicking 'Create Notice of Substantial Amendment' button. Access to the form will be enabled in IRAS as soon as your Submission History for the REC form shows there is a completed version of your initial application for ethical review. The response you have given to IRAS Filter Question 2 will ensure that IRAS generates the appropriate type of substantial amendment form for your study. The same Notice of Substantial Amendment form should be used to notify the amendment to all the appropriate bodies i.e. REC, MHRA (CTIMPs) and NHS/HSC.
All substantial amendments should be approved in principle by the sponsor. For substantial amendments to NHS REC approved LJMU sponsored research, email the following documents to sponsor@ljmu.ac.uk:
-
PDF of the IRAS amendment form.
- Supporting documents
Please allow at least 10 working days for sponsor approval of substantial study amendments. Once sponsorship approval has been confirmed, the completed Notice of Substantial Amendment form should be authorised using electronic authorisation in IRAS.
For further information, including information on amendments to HRA approved research please use the following document:
SOP009 Study Amendments to NHS REC and HRA Approved Research
