If you do not have this letter of approval you may not begin a research project; doing so constitutes research misconduct.
If the study you are involved in at Homerton Hospital is recruiting patients into the study but the treatment and care is being carried out at another hospital, for example at Barts, then you only need to register the study with the R&D office at Homerton Hospital.
If any Homerton resources are being used in a research study that is not being conducted at Homerton Hospital you will need to register the research project wtih the R&D office at Homerton Hospital.
To gain our R&D approval you will need to submit the following to Roger Griffith:
- CV of principal researcher/s
- R&D IRAS application form (parts A, B, C & D if applicable) with signatures (sponsor & chief investigator).
- Ethics IRAS application form (parts A, B, C & D if applicable) with signatures (sponsor & chief investigator).
- SSI IRAS application form with signatures (authorisations required prior to R&D approval no 23 need to add authorisation).
- a copy of the protocol
- patient information sheet (on Homerton University Hospital headed paper)
- patient consent form (on Homerton University Hospital headed paper)
- sponsor letter or ethics form part B signed by sponsor
- correspondence from ethics including approval letter/s.
Authorisations required prior to R&D approval no 23 on SSI Form
This needs to be signed by the Clinical Director or General Manager at Homerton Hospital (ie person in charge of the area).
By signing this section of the form they indicate that they are aware of the research and authorise that it can be conducted their unit/clinical area. If the research involves two main areas ie pharmacy and clinical area then you would need to get the signatures of both managers.
Non Multicentre Research
For Non multicentre research in addition to the above document the R&D office requires evidence of two Peer Reviews for the study.
The peer reviewer must be a person who is external to the trust and not involved in the research project. It is your responsibility to obtain the peer review and to forward to the Research and Development Department at Homerton Hospital along with the CV of the reviewer.
Peer Review forms are available if required from the R&D team on request.
Clinical Trial Research
For clinical trials the R&D office will require the following additional documents:
- clinical trial agreement
- form of indemnity
- finance agreement
- “notice of acceptance” from the MHRA
- copy of a recent (less than a year old) GCP (good clinical practice) training certificate for all staff involved in the study.
Homerton University Hospital NHS Foundation Trust currently applies at 45% overhead fee to all commerical studies which are undertaken at the Trust.
If you considering undertaking a commerically funded research study please contact the R&D manager at the earliest opportunty to discuss the study. This will help to ensure that all the correct paperwork is in order to ensure a prompt start to the study and avoid delays in initation visits.
Getting the final Trust R&D approval letter
Once the project has been registered, costed and R&D have received a copy of the ethical approval the project will be put forward for approved. Once the project has been approved the researcher will receive a final letter of indemnity/approval, which will contain the conditions of the approval.
Failure to abide by these conditions may result in the Trust withdrawing R&D approval which allows the research to be conduct at Homerton University Hospital NHS Foundation Trust.
It is only when you have recieved the final letter of indemnity/approval, that the research can commence at Homerton Hospital.
How do I send the documents to the R&D office?
Any documents for R&D approval may be sent electronically to the R&D coordinator.
If a document requires a signature the Research and Development office will require that document in hard copy format.
Once the Research and Development office has received information from you regarding the research study, the project details will be entered onto the R&D database and you will be issued with an R&D number.
This is a unique number for your research project and you are asked to quote it in all correspondence to ensure a speedy reply.