The Royal Berkshire NHS Foundation Trust
(RBFT) R&D Office uses the national online forms.
Researchers will need to complete all relevant parts of the
Integrated research application system (IRAS).
The data set will generate most forms
needed for any research project including ethics, site specific
assessment, MHRA, ARSAC licenses etc.
To access the forms, go to www.myresearchproject.org.uk
You will need to create an account on the IRAS
website to access the ethics forms.
Ethical approval
Before any research can be started within the
Trust it has to receive a favourable opinion from an independent
research ethics committee (REC), as well as approval by the
Trust.
The forms can be saved at any stage during
completion and can be accessed from any computer using an e-mail
address and password.
Please note that it is not the responsibility
of R&D to forward any documentation to research ethics
committees.
Formal definition of a Research Site
For the purposes of ethical review of a
research proposal, a research “site” is defined as the geographical
area covered by one strategic health authority, whether the
research is based in institution(s) or in the community. Even when
the research may physically take place at several locations within
that geographical boundary, a favourable ethical opinion on the
research protocol is required from only one NHS REC within that
strategic health authority boundary.
Where to apply for a favourable ethical opinion
Single site research studies:
A study taking place wholly within the South
Central (formally Thames Valley) strategic health authority (SHA)
is a “single site study”. (The research may take place in
more than one physical location e.g. at both the RBFT and at
Newbury.) You should apply to the research ethics committee (REC)
for the area in which you are based; for the Royal Berkshire NHS
Foundation Trust and the Prince Charles Eye Unit, Windsor the
appropriate committee is the Berkshire REC.
The committee usually meets on the second
tuesday of the month. The administrator will require your
submission at least three weeks before the meeting is due to take
place. You will need to contact 023 8036 3462 to obtain a reference
number before you can submit your application
electronically.
Please note that one you have a
reference number, you have only 3 working days to finalise and lock
your online application.
Before the committee consider any study they
also require the following documentation (if applicable to the
study being reviewed):
- Ethics application forms generated using
IRAS
- Copy of Protocol
- Signed Indemnity form
- Copy of Sponsor letter
- Copy of Clinical Trial Authorisation (CTA)
from the Medicines & Healthcare products Regulatory Agency
(MHRA) if medicinal products are involved
- European Clinical Trials database (EUDRACT)
number issued by the MHRA
- Copy of data collection/record form,
questionnaires
- Copy of participant information sheet and
consent form
- Copy of letter to GP
- The REC may request a copy of the report
written for peer review of the proposed study
- For research involving ionising radiation
(X-rays or nuclear medicine etc) a copy of the risk assessment
forms and associated level of risk estimate
If the REC of your choice is unable to handle
your application, or you have just missed a deadline, you have the
option of whether your application goes to another REC within the
same strategic health authority or wait until a space is available
at the REC of your choice. It is recommended that you wait
for a space on the REC of your choice, since you will have to
attend the ethics committee meeting. A date and time will be
sent in the post.
Once you have approval from a REC you do not
need further ethical approval in the same strategic health
authority. However, if it is not your local area REC, you must
apply for a Locality Assessment from the REC for the area in which
you are based, so that local implications of the proposed research
can be considered. This application is made on the Site Specific
information Form.
More than one research site:
In the first instance you should apply to the
application booking centre (013 8036 3462) who will allocate your
proposal to a REC (after consideration of the localities involved
and the workload of each REC) so that your proposal can be
considered as soon as possible.
Studies approved by a REC still require a
Locality Assessment. The Locality Assessment form is the SSI
Form.
A copy of the IRAS form, and guidelines for
completing it, can be accessed from the web site www.myresearchproject.org.uk
Useful Contacts
Administrator for Berkshire Local Research Ethics
Committees:
Ms Rae Granville
South Central – Berkshire
South West REC Centre
Level 3, Block B
Whitefriars
Lewins Mead
Bristol
BS1 2NT
Tel: 0117 342 1389
Email: scsha.berksrec@nhs.net