HRA Review

The HRA National Research Ethics Service review is required for most research involving NHS patients, staff or facilities, as well as certain other forms of clinical and social science research. Detailed guidance can be obtained from the HRA website or from the Clinical School Research Governance Team.

To help you decide whether your project requires ethical review by the Health Research Authority, please refer to these two decision trees that will guide you as to:

1. Whether your study classifies as research
2. If so, whether you need NHS REC approval

Alternatively, written guidance is given below:

When should I apply to HRA for ethical review?
Research that falls under the Research Governance Framework for Health and Social Care normally requires HRA review. HRA review can be required for both policy and legal reasons; researchers should consider both when deciding where to seek ethical review.

When is HRA review required for policy reasons?

1. When research involves research participants identified from, or because of their past or present use of, services for which the UK Health Departments are responsible (including services provided under contract with the private or voluntary sectors), including participants recruited through these services as healthy controls. The relevant services are NHS/HSC (UK wide), Adult social care (England, Wales, NI) and Children's social care (Wales).
2. When research involves research participants identified because of their status as relatives or carers of past or present users of these services
3. When research involves collection of tissue or information from any users of these services, including those who have died within the last 100 years. Tissue means any material consisting of, or including, cells (i.e. the definition includes saliva, urine and blood).
4. When research involves use of previously collected tissue or information from which the research team could identify individual past or present users of these services, either directly from that tissue or information, or from its combination with other tissue or information in, or likely to come into, their possession.
5. For a health-related research project involving prisoners.
6. When research involves xenotransplantation.
7. For a social care research project funded by the Department of Health and Social Care.
8. Where research has already been reviewed by the Ministry of Defence Ethics Committee (MoDREC) and continues within the services for which the Department of Health and Social Care are responsible, it does not require separate HRA review.

When is HRA review required for legal reasons?
These requirements apply whether or not there is any NHS involvement.

1. When research is a Clinical Trial of an Investigational Medicinal Product (CTIMP).
2. When research is a Clinical investigation of a non-CE marked medical device or a device which has been modified or is being used outside its CE Mark intended purpose, conducted by or with the support of the manufacturer or another commercial company to provide data for CE marking purposes.
3.  When research involves exposure to ionising radiation.
4. When research involves intrusive procedures with adults who lack capacity to consent for themselves, including participants retained in the study following loss of capacity. (An adult is anyone aged 16 or over. Intrusive procedures are those requiring consent in law, including use of identifiable tissue samples or personal information).
5. When research involves storage of relevant material from the living or the deceased on premises without a storage licence from the Human Tissue Authority.
6. When research involves storage or use of relevant material from the living, collected on or after 1 September 2006, and the analysis is not within the terms of consent for research from the donors.
7. When research involves analysis of DNA in material from the living, collected on or after 1 September 2006, and the analysis is not within the terms of consent for research from the person whose body manufactured the DNA.
8. When research takes place in Scotland and involves organs retained from a post-mortem examination carried out on the instructions of the Procurator Fiscal or organs, tissue blocks or slides retained from a hospital post-mortem examination, or tissue blocks or slides retained from a post-mortem examination carried out on the instructions of the Procurator Fiscal, unless lawful authorisation has been given for use in research.
9. For research involving access to, or process of, the confidential information of patients or service users (social care) by researchers outside the normal care team without consent.
10. When research involves processing of disclosable protected information on the Register of the Human Fertilisation and Embryology Authority by researchers without consent.
11. When research takes place in Wales or Northern Ireland and involves patients (or information about patients) receiving treatment in or for the purposes of an independent hospital or independent clinic (and, in Northern Ireland only, an independent medical agency).
12. When research takes place in Northern Ireland and involves residents (or information about residents) at a residential care home or nursing home.
13. When research is a clinical trial involving the participation of practising midwives.

For further details see: http://www.nres.nhs.uk/applications/approval-requirements/ethical-review-requirements/

Researchers and ethics reviewers should also note that there have been recent changes to the remit of NRES RECs. See the attached document for details.