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Ethical approval

Patient having blood test

It's ok to ask - Ask your doctor or nurse about clinical research

 

Applying for Ethical and R&D Approval

Before a study can be started within the Trust it has to receive HRA approval, favourable opinion of the REC, as well as approval by the Trust. Most studies require favourable opinion of the REC also, but certain types of research studies do not. 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).

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.

-Please note that it is not the responsibility of R&D to forward any documentation to research ethics committees.

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, as it is best that you attend the ethics committee meeting to answer any questions they may have about your project.  A date and time will be sent in the post.

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

  • CONTACT DETAILS:

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    Reading,
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