Health Research Authority (HRA) approval
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 way 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 within NHS sites in England (subject to local agreement).
Exceptions to the approval process
However, there may be situations where studies only need to go through part of the process or bypass it completely, for example:
- 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 for a NHS REC review. The researcher would submit an application to the NHS REC only.
- 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.
- 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.
You will require HRA approval for:
- research involving the NHS in England.
You will require NHS REC approval for:
- 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; read the full list that require approval from the national social care research ethics committee;
- 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, email: