It's ok to ask - Ask your doctor or nurse about clinical research
R&D will need a copy of the IRAS forms and the site-specific form (SSIF) which is found on the IRAS website.
Approval by one of these bodies does not automatically confer approval by the other. Also approval by a University Ethics Committee is not the same as from an NHS Research Ethics Committee.
All projects which involve:
must have a favourable ethical opinion from an Ethics Committee and Trust R&D approval.
All research in the NHS must be conducted in accordance with the Research Governance Framework for Health and Social Care (2005). Research that involves a clinical trial on an investigational medicinal product must be conducted in accordance with 'The Medicines for Human Use (Clinical Trials) Regulations 2004'.
Any research projects which are conducted within the Trust without ethics or R&D approval are not legally recognised by the Trust and are in breach of the Research Governance Framework.
For a valid application one copy of the following documents should be submitted to the Trust R&D Office:
Own account studies and student studies
All documents must be dated and have version numbers.
In the Trust mandatory authorisation on the SSI Form will be required from:
NB. This list is not exhaustive. Depending on the research study, other departments may also need to sign the SSI form.
Once the R&D office receives a valid application, feedback on the application will be given within ten to fifteen (10-15) working days.
As and when required, R&D can co-ordinate the following processes on your behalf:
For all data protection issues, please contact: Caroline Lynch 0118 322 5335
A pharmacist has a professional, moral and ethical duty in law to ensure that any product supplied by them will not harm patients.
For clinical trials the Trust pharmacist must also ensure that legal and statutory requirements relating to the use of unlicensed drugs are met and that Pharmacy are able to provide the required pharmaceutical and staffing resources before, and during, the trial.
Trials involving drugs require the authorisation of a senior pharmacist before submission to the Ethics Committee.
Requests for Pharmacy approval must be made as early as possible before the last date for submission to the Ethics Committee and must be accompanied by all the relevant documentation i.e. protocol, consent forms, GP letters and information sheets. It would be helpful if copies of prescription forms, dispensing logs and dispensing instructions etc were also available at this time.
The Trust Pharmacy makes a charge for commercial trials: contact one of the pharmacists for a list of current charges.
Clinical Trials Pharmacist:-
Tel: 0118 322 7799
Research & Development,
Level 2, North Block
0118 322 8140