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Before the study starts

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Research Facilitation Group (RFG) review is a standard process for principal investigators to complete for new research studies that involve University Hospitals Birmingham NHS Foundation Trust (UHB):

  • patients
  • facilities
  • equipment
  • data, or
  • staff

No objection studies do not require RFG review.

On registering a study, the Research and Development (R&D) Governance team will advise if it requires an RFG review. The RRK reference should be included in any correspondence.

The principal investigator must complete an RFG questionnaire and submit a data set that will facilitate an operational capacity and capability review.

An RFG questionnaire must be completed by the principal investigator and submitted with a data set that will facilitate an operational capacity and capability review.

Staff with access to R&D Manager should ensure the correct documents are uploaded before requesting a review slot. Manuals, grant applications and protocols can be uploaded at the end of the RFG questionnaire before clicking submit. If you do not have access to R&D Manager, please email the RFG with an RRK reference to upload the documents on your behalf.

Please ensure the following information is provided or uploaded:

  • Research Ethics Committee (REC)/Health Research Authority (HRA) approval documents
  • Latest protocol
  • Blank patient information and consent form
  • Completed principal investigator questionnaire
  • Funding details (i.e. grant application, lead site award letter, statement of activities or events if participating)
  • Investigator brochure, material safety data sheet or pharmacy review sheet sample IMP labels (dependent on Pharmacy involvement)
  • Manuals for relevant teams (i.e. Labs, Pharmacy or Imaging)

Any information that is not available or applicable should be detailed in the email or R&D Manager submission.

Remote review and approval

Research studies may be reviewed and approved remotely but this is dependent on:

  • the study complexity
  • the specialty having an internal research infrastructure (with terms of reference) and can support the study set up and delivery (i.e. the speciality has research nurses with capacity)
  • the study being internally peer reviewed and approved (i.e. the CRF Scientific Advisory Committee or Internal Research Speciality Group)
  • there being no implications to the following:
    • Labs
    • Imaging
    • Pharmacy
    • Informatics
    • Therapy Services
    • Research Delivery team

Review slot

Depending on the study complexity, it will be reviewed and approved remotely or a face to face presentation will be requested.

Review slots are confirmed after receipt of a completed RFG questionnaire and the minimum document set.

Review process

The review process works in parallel to the R&D Governance approval and contracts process. RFG approval is required as part of the review process.

Reviews can be turned round quickly if all the required information has been provided and the necessary service/department reviews have taken place.

Principal investigators and lead research nurses will be notified of RFG approval by email.

If you have any questions, please email the RFG.

Last reviewed: 18 May 2021