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R&D approval

All NHS research must be registered and reviewed by the relevant NHS R&D office. NHS Trusts must confirm their capacity and capability to host the research project (formerly called R&D approval).

This means that you cannot begin your research in SLaM until you have submitted the relevant paperwork and received confirmation that you can start recruitment from the R&D office.

There are three routes for setting up a research project in SLaM, depending on who your sponsor will be: 

If your study is sponsored by a commercial organisation you will need to contact the KHP Clinical Trials Office, who will undertake the administration and contract negotiations for these studies.

KCL and/or SLaM NHS FT sponsored studies

Research studies led by SLaM, and research studies led by KCL that involve SLaM facilities or patients are managed by the SLaM/IoPPN R&D office (this includes where SLaM has been awarded external funding for the study).

The R&D office will assist you in setting up your research project in line with the UK Policy Framework for Health and Social Care Research.

We will faciliate your application to the REC and HRA and advise you on preparing the local information pack for NHS site set up.

For further details, please contact the R&D office:

slam-ioppn.research@kcl.ac.uk 020 7848 0790

If your research is led by an external organisation but you would like to run the study at SLaM

We follow HRA guidelines on setting up research projects in the NHS. Further information is available on the HRA website.

Please send through the local information pack from the lead organisation to slam-ioppn.research@kcl.ac.uk

R&D will check that SLaM has capacity and capability to host the study. R&D will issue an email to confirm ‘capacity and capability before you start your research.

 

Documents to be submitted for R&D capacity and capability review

You will need to submit the following to the R&D office when requesting a capacity and capability review: 

Local information pack:

  • Copy of IRAS Form as submitted for HRA Approval
  • Protocol
  • Participant information and consent documents 
  • Relevant model agreement (if applicable)
  • Organisation Information Document and Schedule of Event templates (including known information)
  • Any other documents that the sponsor wishes to provide to the site to support the set-up and delivery of the study
  • Copy of HRA initial assessment letter (if one is issued) and (when issued) HRA Approval letter and final documents.

The HRA initial assessment or HRA Approval letter will provide information relevant to study set up. 

CTIMPs have additional legal requirements. Please refer to our clinical trials page for further information.

Separate SSI forms are no longer needed in the UK. Please check the IRAS website for the latest guidance on site set-up

Site Specific Approval for non-NHS sites - please check the latest guidance on the IRAS website

Participant Identification Centres (PIC) - please check the latest guidance on IRAS

All research involving the NHS patients must have ethical approval from an NHS Research Ethics Committee (REC) before it can begin. Please see our ethical approval page for further information.

The involvement of service users and the public is a key element of the Research Governance Framework. There is a group established called The Service Users Research Enterprise (SURE) which supports this within SL&M/IoPPN. In addition there is a group entitled the Consumers in Research Advisory Group (CRAG) which provides support to service users who sit on the R&D Steering Group. More information regarding these groups or directly from the SURE webpages.

Research in SLaM