Types of R&D approval given

The Trust’s research authorisation procedures are not linked to the ethics or regulatory processes and can be undertaken at any point before, during or after processing by an ethics committee  and where applicable another regulatory body i.e. the MHRA.   However, Trust approval for a study is only provisional until the R&D Governance Office has copies of the full ethics committee and regulatory approvals.

Provisional approval can be given when:

  • the Trust assessment has been completed
  • the R&D Governance Office has confirmation of the funding arrangements
  • and, for commercial studies, a finalised version of the clinical trial agreement is ready for signature.

You should not start recruiting patients to a trial until you have full approval

Full approval will be confirmed when the R&D Governance Office has copies of:

  • Regulatory approval (usually MHRA or NIGB)
  • Ethics Favourable Opinion
  • If necessary, updated copies of the protocol, patient information sheets and consent forms to match the versions approved by the ethics committee and regulatory authorities

“No Objection” Studies

We have a simplified process for certain types of studies that are likely to have little impact on the Trust. For these studies we will issue ‘No Objection’ rather than full authorisation. This restricts the activities that can be undertaken. The types of studies that may be considered for this process include those that involve:

  • Identification of potential participants who then contact external researchers directly if they are interested in taking part (referred to in IRAS and CSP as “PIC” sites)
  • Provision of a service for patients of other Trusts that would have been carried out in standard clinical care (e.g. imaging, radiotherapy). Note, that if the service would not normally be provided then the full Trust authorisation process must be followed
  • Provision of anonymised tissue samples from an HTA-licensed tissue archive e.g. pathology. Note that prospective collection of tissue samples is likely to require full Trust authorisation
  • Provision of anonymised clinical data on patients
  • Administering questionnaires to UHB staff members