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Ethical approval

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Applying for Ethical and R&D Approval

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 website: 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

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