The HRA will first validate whether your application is complete for REC review (for those studies that require REC review), you will be notified if it is valid for REC review no more than 5 working days after submission. If going for full REC review it’s a good idea to attend the meeting.
The HRA has published their assessment criteria and standards. This includes information on what should be included in patient information sheets and the protocol, and is largely aimed at sponsors who will want to assure themselves that applications will meet the assessment criteria and standards. The HRA will assess the following (includes the relevant page number in version 3.4 of the HRA Standards document):
- For staff who do not hold a substantive contract with the NHS organisation where the research will take place, the HRA will confirm what is needed e.g. an honorary contract, a letter of access, the necessary pre-engagement checks, etc. (page 3)
- Principal investigator suitability (page 3)
- The level of capacity and capability assessment needed by sites (page 4)
- Intellectual property arrangements (page 6)
- Assurances to NHS sites that the study is accurately described (including any treatment and participant care during and after the study) and is compliant with legislation (page 11)
- The consent process and participant information correctly informs potential participants, meets legal requirements and is consistent with other study documents (page 11). Please also see the MRC / HRA Consent and Participant Information Sheet Preparation Guidance
- In studies where REC review is not required e.g. those involving NHS staff as participants, the HRA will consider the ethical issues and may decide REC review is required (page 12)
- Assess the protocol content and consistency with other study documents, and the use of templates where available (see CTIMP protocol template and qualitative protocol template) (page 16)
- Allocation of responsibilities and rights and clarity to the NHS on the agreements intended for use by the sponsor (page 17)
- Template agreements are used without modification or justification given for modification (page 18)
- Insurance and indemnity arrangements (page 20)
- Financial arrangements (page 25)
- The use of patient data and legal compliance (page 28)
- Compliance with CTIMPs (page 35)
- Compliance with other relevant legislation (39)
- All relevant approvals and authorisations have been received (application is in parallel to all relevant approvals bodies, e.g. CAG, MHRA; but HRA Approval won’t be given until these have been received) (Page 47)
During HRA assessment the HRA may contact you for more information, usually by telephone then by a follow-up email, so please be available after you have submitted your application.
Following any requests for further information, you should expect to receive an Initial Assessment Letter from the HRA. When you have this you can send documents to NHS sites, see Working with individual NHS sites in any UK nation.
All formal correspondence from the HRA is sent to the person listed as sponsor contact in IRAS A4 as well as the CI (IRAS A3) and the Lead NHS organisations (IRAS A68-1). This ensures that the right people get the information. The person listed in IRAS A4 should be the main contact for the study.
The REC Manager will be in contact about the passage of your application through REC review.
When the assessment is complete, you should expect to receive an HRA Approval letter to share with individual NHS sites.
If you have any queries about the assessment of your application, email the HRA Approval team.