HRA approval - helpful information for researchers

The two main points to be aware of are: HRA approval will be the process for applying for all research projects in the NHS led from England; and NHS permission is replaced with a confirmation of Capacity and Capability. For more details read the JRO's previous coverage of HRA approval.

The JRO has detailed links to helpful information below for researchers now all research applications, with the exception of studies being undertaken solely for educational purposes, come under HRA approval.

• E-learning modules, slide sets, leaflets and links to recorded webinars can be found on the HRA Approval Training Resources webpage
• The HRA Approval Questions and Answers document has been updated
• Amendments for all studies (including pre-HRA Approval studies) where the lead NHS R&D office is in England are categorised and assessed by the HRA. See the HRA website for more details.
• Studies set up using pre-HRA Approval processes (CSP and other systems) which want to open the study at new participating organisations in England follow specific HRA processes. They should be used only when new sites need to be opened.
• Where the NHS organisation was listed on Part C of the original application (or had the new site agreed by a previous amendment) the applicant sends a request to hra.approval@nhs.net asking that the study is issued with HRA Approval. The request should include a list of the current REC & R&D approved study documents along with template agreements and those documents should be attached.
• Where the study has been subject to review by other bodies (e.g. MHRA), evidence of the outcome of the review by that body should be provided. Superseded study documents (as a result of substantial and non-substantial amendment) should not be included.  Guidance is provided on the HRA website. There is also an optional template which can be used to list the documents provided.
• Where the NHS organisation has not been listed on Part C of the original application (or had the new site agreed by a previous amendment), the applicant should use the amendment process to add a new participating NHS organisation. Where an amendment is to add a new site to a study previously processed through pre-HRA Approval systems, the HRA Assessment Team will ask researchers to provide a list of the current approved document set and copies of the same along with the template agreements and costing information that will be used when working with the new site.
• Applications to set up research at sites in the Devolved Administrations remain unchanged. Site Specific Information Forms are required for sites in Northern Ireland, Scotland and Wales.