What approvals are needed?
The approvals process for research to commence in the NHS in England has changed.
NHS permission is now provided by a Non Department Public Body called, Health Research Authority (HRA), which replaces the local R&D approval process whereby NHS permission is granted by individual Trusts. This process applies to all NHS research led from England (there is a slightly different process for NHS research led from other areas of the UK – please check the HRA website if this applies to your research project).
The aim of this new process is to align the Research Ethics Committee (REC) approvals process with NHS permission, to reduce duplication by creating a single HRA assessment.
This allows participating organisations (Trusts) to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study. NHS Trusts are still responsible for formally confirming the study can be undertaken within their organisation and contact with the appropriate R&D office should be done as early as possible in the process.
Guidance before you apply
Oxford Health NHS Foundation Trust (OHFT) formal confirmation process
The sponsor should provide a completed Statement of Activity (SoA) form at the earliest opportunity to the R&D office via the following email email@example.com
A template SoA can be found on the HRA website.
The Trust will conduct a feasibility assessment ahead of HRA approval being issued. Once HRA approval is in place the R&D office will issue a letter confirming capacity and capability. In addition the Trust will provide the sponsor with a pdf copy of the agreed SoA form, which will form an agreement between the Trust and the sponsor for the research project ahead of the research commencing. The SoA form should be the same version as that listed in the HRA approval letter.
The Trust will confirm capacity and capability only when authorisation has been obtained from the appropriate Service Director, responsible for the Directorate where the research activity will take place. Provision of this authorisation should be provided to the R&D office at the earliest opportunity as this may cause delays in confirming capacity and capability. An email from the Service Director confirming authorisation is acceptable.
|Adults||Rob Bale Clinical Director/Eddie McLaughlin|
|Older Adults and community||Pete McGrane Clinical Director/ Anne Brierley|
|Children and Young People||Pauline Scully Service Director/ Wendy Woodhouse
Please contact Anne Booth in the first instance
Completion of the Statement of Activities (SoA)
Please ensure that the green sections of the SoA form are completed or agreed by individual Trusts. Item 3 requires the name of the authorised individual responsible for confirming capacity and capability on behalf of the Trust. For OHFT the authorised individual is;
- Professor John Geddes, Director of R&D
Model Agreements (Contracts)
Assessment of Capacity & Capability
In order for a site to commence the assessment of capacity and capability the following minimum defined documents must be provided to the R&D office;
- HRA Initial Assessment Letter or HRA Approval Letter
- IRAS Form as submitted for HRA Approval
- Any amendments
- Participant Information Sheet and Consent Forms
- * Statement of Activities (SoA) form (non-commercial only) or Delegation Log (commercial only)
- Relevant template contract/model agreement (where applicable if needed in addition to the SoA)
- Costing Template (commercial only) or Schedule of Events (non-commercial only)
- Any other documents that the Sponsor wishes to provide to support the set-up and delivery of the study
- When issued the HRA Approval letter and final document versions
The Statement of Activities should be the same version as that listed in the HRA Approval letter
Registering all research being conducted within the Trust
Some studies that have been approved by the HRA are not required to obtain confirmation of capacity or capability from individual NHS Trusts. Oxford Health NHS Foundation Trust requires all research projects to be registered with the R&D office as a matter of good practice. OHFT’s policy requires all researchers to register their project with the R&D office ahead of any research activity regardless of whether formal confirmation of capacity and capability is required.
Please contact firstname.lastname@example.org to register your project.
Conditions when HRA approval may not be required
Single-site student studies sponsored by Oxford University
If your study has Oxford Health as the only NHS site in England and it does not require review by an NHS REC, and the study is sponsored by the University of Oxford, the Trust’s R&D Department will not require you to obtain HRA approval prior to starting the study.
To obtain Trust permission you will need a Protocol based on a template supplied to you by the University’s Clinical Trials and Research Governance department (contact: email@example.com), other study documents, and confirmation of successful completion of an appropriate ethical review as required by the University. You will not need to submit an IRAS Form. Studies which do not need NHS REC review include studies using only previously collected and anonymised: patient data, tissue, or acellular material (e.g. DNA), or NHS staff.
Last updated: 14 August, 2017