Trust approval (R&D approval)

When the appropriate ethical approval is in place and before the study can commence, R&D undertakes a governance assessment of the study to confirm that the research will be carried out safely using Trust facilities and is in line with appropriate policies and procedures together with national and EU legislation and is compliant with the Research Governance Framework. This review can be undertaken in parallel with the ethical approval process.

All departments involved in the research need to be aware of the study and satisfied that there are appropriate resources in place to undertake this research. Where support departments are involved in the research, the study will also be reviewed by those involved, for example Pharmacy.

These approvals are vital to protect service users and their data as well as to protect the researchers themselves and their sponsoring institution from avoidable risks.

Service user and carer involvement is an important part of the CPFT R&D approval rpocess.  Involving services users and carers from the very early stages of research can make our research more relevant, respectful and beneficial to the people we support.  The research studies that are sponsored by CPFT need to demonstrate appropriate levels of service user and carer involvement and all locally developed research projects are reviewed by service users and/or carers.  For further information and advice please contact the User and Carer Manager, Iliana Rokkou.  

When both the ethics approval is in place and the governance checks are complete, Trust R&D approval is issued and the study can commence.

The application process

To start a new clinical research project, the research team need as a minimum ethics and R&D approval, and depending on the scope of the research additional approvals by, for example, the MHRA (for medicines and medical devices) or GTAC (gene technology). The necessary forms for these submissions can be completed through IRAS.

The key forms are:

  • REC application form (this will be reviewed by ethics)
  • R&D application form (this is reviewed by the R&D Department)
  • SSI Form: Site specific information - this can be in several copies, one for each of the sites involved in the study. These are reviewed and approved by each individual site’s R&D Department

Alongside the steps of peer review, establishing sponsorship arrangements and determining funding, researchers can start completing the forms in IRAS. These multi-purpose, online documents form the basis of all future steps in the application and authorisation processes.

Approval timescales

The Trust aims to approve studies in a timely way and in accordance with nationally-agreed timescales.  

The page was last updated on 27 March 2018 by aient.


Cambridgeshire and Peterborough NHS Foundation Trust
Elizabeth House, Fulbourn Hospital
Cambridge, CB21 5EF

T 01223 219400 (open 8:30am to 5pm)
F 01480 398501

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