Getting my research started in Southern Health
Before you can begin your project, you will require a number of authorisations in line with the Research Governance Framework.
The appropriate level of authorisations is generated via the Integrated Research Application System (IRAS), which is your first requirement for obtaining NHS R&D approval.
Guidance on how to complete the IRAS form is available on the IRAS website. You can also obtain approvals for the relevant Research Ethics Committee (REC). You'll need to submit the study document set generated by IRAS to the R&D office.
Once you satisfy the subjected checks, the R&D office will issue you with a formal letter of approval signed by the Director of R&D. Only then will you be able to begin you research at the Trust.
Register for an IRAS account
REC approval and Proportionate review
Your study may be eligible for ‘Proportionate Review’ or may not require full Research Ethics Committee (REC) approval.
Proportionate Review is suitable for studies where there is minimal risk, burden or intrusion for participants.
Applying for ethics approval
1. Complete Research Ethics Committee (REC) form in IRAS
Relevant documents will be requested as per applicant checklist on IRAS
2. Book the application for ethical review
Once your application is ready, telephone your local REC to book a meeting date for discussion of your application. You will be given the name of a REC, a Reference number, and submission date
3. Submit your application
Your application must be submitted to REC within 4 working days of making your booking
For more information on booking and submitting your ethics application.
Download the standard Research Governance checklist.
For CI: Reporting to REC, HRA and R&D offices
Substantial amendments are reported by the CI on a Notification of amendment (NOA) from within the IRAS form and submitted via e-mail to the REC committee that approved the study and also to the HRA via HRA.firstname.lastname@example.org. The e-mail should include all amended study specific documentation and study supporting documentation.
- Non-substantial and FYI amendments are reported via the Notification of non-substantial/ minor amendments for NHS Studies and submitted via e-mail to the HRA according to the instructions within the document.
For website information and supporting documentation please see below.
- The date of the amendment is the date on page 4 of the NOA, the last statement in the middle box on the page headed by Full title of the study.
- The amendment number, version number and date must be stated on each of the amended study-specific documents; headers and footers must match both for date and version number. It is recommended to include track change documents and clean documents of the new versions.
- The IRAS NOA must be signed electronically by the CI and sponsor. The non-substantial amendment form should be signed in wet ink and saved and submitted in pdf format.
- The Amendment will not be implemented until regulatory review and participating research sites have received the amendment. Participating sites have 35 days after notification by the sponsor to review and raise any objection (for example if new financial terms are required to be negotiated or services have changed and the site no longer has capacity or capability to host the study).
- NB: The ONLY exception is where the amendment concerns a safety issue, in which case the safety of the participant is paramount and the amendment must be implemented and host sites informed immediately the issue arises. REC, HRA and MHRA where applicable should also be informed via this amendment procedure.
- Where the PI changes in a host site this must be communicated to the CI/Sponsor/trial manager with the CV and GCP certificates and the following will apply:
- If the study is a CTIMP study this must be communicated to REC as a Substantial amendment so the study should not continue at the site without a REC approval letter and recruitment will pause at the host site.
- If the study is a non –CTIMP study the onus is on the CI/Sponsor/trial manager to report to REC as appropriate and the study may continue recruitment at the hosting site subject to acknowledgement of the change from the CI/Sponsor/trial manager.
Southern Health Sponsored Trials
- For substantial amendments, a supporting letter signed by the R&D manager (Sponsor’s representative) in addition to the electronic signature of the NOA should be included in the submission pack. This is good practice for non-substantial amendments and notifications.
- If the amendment concerns a safety issue participating sites must be alerted to the safety issue as soon as it arises.
- The amendment submission must also be made to other applicable regulatory organisations (MHRA, ARSAC certificate etc).
- On receipt of the HRA confirmation e-mail the CI will forward the e-mail to the R&D offices of hosting sites with the submission pack.
- The CI must consider any financial impact the amendment may have for host sites, and prepare a Variation of Contract for signature by the relevant host site.
- Where the PI changes in a host site this must be communicated to the CI and R&D Manager at Southern Health NHS Foundation Trust with the CV and GCP certificates and the following will apply:
- If the study is a CTIMP study this must be communicated to REC by the SHFT CI as a Substantial amendment. The study should not continue at the Host trial site without a REC approval letter and recruitment will pause at the host site.
- If the study is a non –CTIMP study the onus is on SHFT CI/Sponsor/trial manager to report to REC as appropriate and the study may continue recruitment at the hosting site subject to acknowledgement of the change from the CI and SHFT as Sponsor.
The Amendment must not be implemented until regulatory review and participating sites have received the amendment. Participating sites have 35 days after notification by the sponsor to review and raise any objection.
- NB: The ONLY exception is where the amendment concerns a safety issue, in which case the safety of the participant is paramount and the amendment must be implemented and host sites informed immediately the issue arises.
During Regulatory Review
The HRA will review the amendment in line with the HRA guidance on handling study amendments and issue e-mail confirmation within 5 days that the amendment is valid together with the category of amendment. The e-mail will also include instructions for participating NHS organisations in England – Confirmation of Assessment arrangements:
- Category A: An amendment that has implications for, or affects ALL participating NHS organisations.
- Category B: an amendment that impacts or affects SPECIFIC participating NHS organisations. Only at these organisations does it need to be considered and take any change control actions required.
- Category C: An amendment that has no impact on NHS organisations, hence does not require management or oversight, R&D departments do not need to be notified of such amendments, however will have access to all documentation within their national IT system.
REC will review Substantial Amendments through substantial amendment Sub-Committee and confirm acknowledgement of valid amendment application and date of the next available sub-committee.
- NB: The ONLY exception is where the amendment concerns a safety issue, in which case the safety of the participant is paramount and the amendment must be implemented immediately without awaiting the REC/HRA instructions.
R&D office Review of amendment
On being notified of an amendment (applies to both substantial and non-substantial):
- Unless the amendment is for a safety issue, check that Regulatory approval is in place before implementing amendment: HRA categorisation, REC approval (where necessary), any other necessary: MHRA, ARSAC certificate etc.
- Check the amendment narrative and the documents listed in the NOA to assess the impact of the amendment to the trial locally and that the IRAS project filters are still correct (e.g. if the use of ionising radiation or collection/storage of tissue samples procedures have been added). Request any missing documentation from the sponsor or trial manager.
- Consider the capability and capacity of the site to implement the amendment and if necessary alert the PI/CI or trial manager or sponsor to any issues arising.
- Cross check the documentation approved by REC tallies with the documentation listed in the NOA (versions and dates).
- If a funding agreement is in place for the study the R&D office will review the new amendment for impact to the funding agreement and if necessary negotiate with the Sponsor to update the finance schedule.
- The CI and PI, trial manager and Sponsor must be alerted that the amendment will not be approved until the finance schedule has been updated and signed.
- Ask the research team to put new versions of PIS/consent/other information letters onto headed notepaper as appropriate and upload the new versions to the EDGE site. Ensure that preceded documentation is deleted from EDGE.
- Create a new folder in the project record in the shared drive/Research study directory/(project name) entitled: Amendment (no/date).
- Complete an amendment received and read log to send with the approval letter.
- Prepare approval letter for signature by R&D Manager and send to the PI with a copy of the updated amendment history and amendment received and read log. Ask the team to complete and sign by the PI and return copy to the R&D office.
- Scan in the signed approval letter and e-mail (using the e-mail template) to the CI, PI, CRN, trial manager, sponsor, SHFT R&D lead facilitator with the amendment history, Amendment read and received log plus all the approved documentation pack (zipped from the study file in the shared drive).
- File returned log in the Governance file with the other amendment documentation, checking that the PI and all in the research team have signed.
HRA and IRAS web site links and supporting documentation: