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Obtaining R&D approval

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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: Caroline Lynch 0118 322 5335

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

Useful Contacts

Research & Development,
Level 2, North Block
London Road
Reading, Berkshire
RG1 5AN

0118 322 8140

  • CONTACT DETAILS: Royal Berkshire NHS Foundation Trust, London Road, Reading RG1 5AN
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  • Tel: 0118 322 5111