Guidance on Applying for HRA Approval (formally NHS R&D)
Note: If your study does not involve the NHS in England or NHS patients, their tissues or their data, NHS staff or NHS facilities or equipment, please choose the 4th option: 'No: it only requires review by the University Research Ethics Committee or a Division/School based Committee' to continue with this form.
HRA Approval Process
In March 2016, the Health Research Authority (HRA) fully launched the HRA approval process. This streamlined process, which applies to research carried out in the NHS in England, brings together a new process of conducting governance and compliance checks on behalf of NHS organisations (HRA study-wide assessment) with independent NHS REC review (where required). HRA study-wide assessment is carried out by HRA assessors and replaces some of the checks that were previously carried out by individual Trusts as part of the old R&D approval process.
One of the benefits of the new system is that researchers only have to submit one application to the HRA. In most cases, this single application (which requires an IRAS form) will go through NHS REC review and HRA study-wide assessment in parallel. Once the REC approval is in place and all the HRA study-wide assessments have been completed, the study will be issued with HRA approval which means it can go ahead to within NHS sites in England (subject to local agreement).
However, there may be situations where studies only need to go through part of the process or bypass the HRA approval process completely:
Example 1- a study is taking place in a community setting with individuals who are not patients but who do lack capacity to consent. As this study does not involve the NHS, HRA approval is not required but, it does involve adults that lack capacity to consent so there is a legal requirement NHS REC review. The researcher would submit an application to the NHS REC only.
Example 2- a study was taking place in a hospital but the participants are members of staff recruited within their professional capacity. This would be exempt from REC review (based on the Governance Arrangements for RECs) but would need to have HRA approval (HRA study-wide assessment only). The researcher would submit an application for HRA approval indicating it is exempt from REC review.
Example 3 – a study is taking place in the NHS and involves patients but is being carried out in Wales. The study would require NHS REC review because of patient involvement but, as it is being conducted outside of England, it would not require HRA approval. The researcher would submit an application to the NHS RECs and also to the R&D office for the NHS site.
How does HRA approval fit with UREC approval?
For the majority of research involving human beings, their tissue or data which is carried out on behalf of the University, the University expects it to have gone through a process of ethical review.
If your study has gone through NHS REC review as part of the HRA approval process or even outside of this process, you don’t need to apply for UREC review; the activities listed in the protocol and IRAS form will be covered by the NHS REC approval and this will satisfy the University’s requirements.
Where your study does not require NHS REC approval, it may need UREC approval to satisfy the University’s requirements. Unless the study was also exempt from UREC, you would need to make an application for UREC review.
If your study does require UREC review but also HRA approval i.e. it is being carried out in the NHS but exempt from NHS REC review, then you will need to the through both review processes. These review processes are independent and each requires a separate application form to be completed. The same core study documents (protocol, information sheets etc.) should be used for both review processes.
You will require HRA approval if:
- Your research involves the NHS in England
You will require NHS REC approval if your research will involve any of the following:
- NHS patients, their data or tissues
- NHS staff where the research is not limited to non-sensitive questions about their personal role
- Participants who are users of any services for which UK Health Departments are responsible. This includes adult social care in England under certain circumstances; a full list of circumstances that require approval by the National Social Care Research Ethics Committee can be found here
- Prisoners in the custody of the National Offender Management Service, the Scottish Prison Service or the Northern Ireland Prison Service, where the research is health-related
- Adult participants who, under the Mental Capacity Act, may lack the capacity to provide informed consent
- A non-CE marked medical device
- Exposure to ionising radiation
- Processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority by researchers without consent
- A clinical trial involving the participation of practicing midwives
- Participants who are being identified due to their past use of NHS services
Please visit their website for more information on the NHS REC or HRA review/approval process and the additional specific instances in which either NHS REC or HRA approval will be required.
If you are unsure as to whether your research will require approval via the NHS REC or the HRA, please use the HRA Decision Tool. The answer to this tool is definitive and it is strongly recommended that you save a copy of the result for your records.
If you have any additional queries about the specifics of your research project, please use the following contact:
- Lynne MacRae for those in all Faculties (email: FBMHethics@manchester.ac.uk)
For studies requiring UREC Review and HRA approval (HRA study wide assessment only or R&D approval outside of England) please complete the following steps:
1. Complete the UREC application form which will be submitted to your Ethics Signatory for a pre-screen check. Once checked it will be forwarded for allocation at the next available UREC Committee meeting (or sent out to the digital Proportionate UREC Committee).
2. If required, please ensure you amend your application and supporting documentation in accordance with the feedback provided by the Committee and re-submit for final approval.
3. Once you receive your letter of ethical approval, complete an IRAS application.
4. Forward your completed IRAS application form (unlocked), letter of ethical approval from UREC and all supporting documentation (including (research protocol, faculty research approval form/PanMan form, Insurance Assessment form, Statement of Activties and Schedule of Events) to your University Sponsor representative who will aim to review your documentation within one working week.
5. Your sponsor representative will liaise with you directly regarding any clarifications to your documentation and will also generate your letters of insurance and indemnity. If required, please ensure you amend your IRAS form and supporting documentation in accordance with the feedback provided by the University Sponsor representative and re-submit for final sign off.
6. Once you receive confirmation of sponsor approval, submit for HRA approval via the IRAS system and ensure you send your sponsor representative an electronic authorisation request via IRAS to enable them to sign your form.
7. Your application will then be sent to one of the HRA advisors for assessment and approval.
8. Once you receive confirmation of HRA approval, the documents must be sent by the CI to the NHS sites for the capacity and capability assessment. In addition, copies of the approval letter and confirmations of the capacity and capability assessment should be sent to the sponsor representative for their records. Please note: NHS sites are able to provide confirmation that a study can be undertaken via a capacity and capability assessment, but will not have the authority to provide approval.
9. You must also submit a formal amendment in the ERM system to your approved UREC application. In this amendment request please attach a copy of the HRA approval as well as copies of any supporting documents that have been updated since UREC approval was obtained.
10. Once the amendment has been approved by the UREC, forward a copy of the confirmation email to your University Sponsor representative who will then provide the sponsor green light for your study.
For more information about the HRA Approvals Process, see their website.
*For Human Tissue Studies*
You will be required to store and use the samples under the University of Manchester's HTA License for Research as well as seek appropriate UREC approval. Please see our HTA Guidance for more information.