Obtaining R&D approval
R&D will need a copy of the IRAS
forms and the site-specific form (SSIF) which is found on the
IRAS website.
- Trust R&D approval is separate from
ethical approval process.
- R&D requires a copy of everything
that goes to REC.
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:
- trust staff
- trust patients
- access data
- access samples
- use of NHS equipment
- access to NHS property for research
purposes
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.
Valid R&D Applications
For a valid application one copy of the
following documents should be submitted to the Trust R&D
Office:
Non-commercial studies
- Electronic or printed copies of IRAS
Form
- Printed copy of SSI form with signature(s)
(R&D can help with obtaining these)
- Copies of all documents provided for the
ethical review (e.g. Protocols, information sheets, consent forms,
GP letters etc.)
- REC approval letters
- Written evidence from the organisation(s)
acting as sponsor that they have agreed to accept the
responsibilities of sponsor
- A copy of the study plan where relevant
- Copy of honorary contract for RBFT, where
applicable (R&D office can arrange)
Commercial studies
- Electronic or printed copies of IRAS
Form
- Printed copy of SSI Form with
signature(s)
- Copies of all documents provided for the
ethics review (e.g. Protocols, information sheets, consent forms,
GP letters etc.)
- REC approval letters
- Clinical Trial Agreement (CTA)
- Written evidence from the organisation(s)
acting as sponsor that they have agreed to accept the
responsibilities of sponsor - may be part of CTA
- ABPI Indemnity on Trust or company letterhead
(copy available from R&D Office) – may be part of CTA
- A copy of the study plan where relevant
- Copy of honorary contract where applicable
(R&D office can arrange).
Own account studies and student studies
- Electronic or printed copies of IRAS
- Printed copy of SSI Form with
signature(s)
- Copies of all documents provided for the
ethics review (e.g. Protocols, information sheets, consent forms,
GP letters etc.)
- REC approval letters
- Copy of the study plan where relevant (see
question specific advice, section 4)
- Copy of honorary contract where applicable
(R&D office can arrange)
- Peer Review of own account studies (R&D
office can arrange)
- Peer Review of student studies, academic
staff at the University can peer review
- Sponsorship of own account studies (R&D
office can arrange)
- Sponsorship of student studies, written
evidence from the University is required.
All documents must be dated and have
version numbers.
In the Trust mandatory authorisation on the
SSI Form will be required from:
- clinical service unit director
- operations managers
- pharmacy, if pharmacy services are
involved
- radiology, if any extra investigations are
required
- pathology, if any extra investigations are
required
- clinical Engineering if new medical devices
are to be used
- R&D manager.
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:
- scientific review of your project (as
required by ethics committees)
- sponsorship arrangements (own account
studies)
- projects costing (once researchers time is
clearly stated on the forms)
- risk assessment review (for interventional
studies)
- honorary research contracts.
- data protection
For all data protection issues, please
contact: Mike Robinson 0118 322 5364
Pharmacy
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:-
Norma Shields
Tel: 0118 322 7799