UK Health Departments Research Ethics Service
The UK Health Departments have revised the review requirements for the kinds of research activity which must be ethically reviewed/approved by a Research Ethics Committee within the UK Health Departments’ National Research Ethics Service. The arrangements came into effect as of 1 September 2011 and can be seen in full on the National Research Ethics Service (NRES) website.
The review requirements are known as the harmonised 'Governance Arrangements for Research Ethics Committees' (GAfREC), and include both requirements under UK legislation, as well as policy requirements of the UK Health Departments. The circumstances where a research project may need ethical approval through the UK Health Departments’ Research Ethics Service are summarised below:
- Research involving patients or service users of NHS healthcare (UK-wide), Adult social care (England, Wales and Northern Ireland) and Children’s social care (Wales and Northern Ireland) including participants recruited through these services as healthy controls
- Research involving participants identified because of their status as relatives or carers of past or present users of these services
- Research involving the collection of information from any users of these services, or access to/processing of confidential information of patients/service users by researchers outside the normal care team without the person’s consent
- Research involving use of previously collected information from which a past or present user of these services could be identified
- Research involving Xenotransplantation
- Health-related research involving prisoners in the custody of the National Offender Management Service, Scottish Prison Service and Northern Ireland Prison Service
- Social care research projects funded by the Department of Health (please see the following page of the NRES website or the Social Care Research Ethics Committee website for further details)
- Research involving patients (or information about patients) who are cared for in private and voluntary sector nursing homes (in England, Wales and Northern Ireland) and/or residents (or information about residents) of residential care homes (in Northern Ireland only)
- Research involving exposure to ionising radiation
- Clinical investigations of (not simply using) medical devices that are not CE-marked (i.e. not compliant with European Directives) or CE-marked medical devices that have been modified or are being used for a new purpose
- Clinical trials of investigational medicinal products
- Clinical trials involving the participation of practising midwives
- Research involving protected information from the Human Fertilisation and Embryology Authority register
- Research involving participants from the UK Armed Forces, or research funded/sponsored by the Ministry of Defence (such studies will need to gain ethical approval through the Ministry of Defence Research Ethics Committees (MoDREC). See the following page of the NRES website for further details)
- Research involving any individual over the age of 16 who lacks (or loses) the mental capacity to give informed consent to take part (or to keep taking part) in the research
- Research involving human tissue from the living or deceased: There are certain circumstances where ethical approval through the UK Health Departments Research Ethics Service is a legal or policy requirement for research involving the collection/use of human tissue. The requirements are complex, so it is recommended that if your study involves the use of human tissue (whether or not this is from patients/service users within the services for which the UK Health Departments are responsible) you consult the NRES website for further guidance, in particular the ‘Does my project require review by a Research Ethics Committee?’ document which gives guidance on when UK Health Departments Research Ethics Service review is required.
If, after consulting this guidance you feel that your study does not fall under the review requirements of the UK Health Departments Research Ethics Service, then it is recommended you view the ‘CREC flowchart' document on the College's Human Tissue Act Governance Group's website for guidance on other issues which will influence whether your study can be reviewed by the King’s College London College Research Ethics Committee (CREC) and its devolved subcommittees
Note that there are exceptions to these criteria, so it is strongly recommended that should it be the case that you feel your project might fall under the above review requirements, you consult the NRES website for further details. Specifically, the ‘Does my project require review by a Research Ethics Committee?’ document can provide useful guidance on this.
If your project does not require ethical review through the UK Health Departments Research Ethics Service, and is a project that falls under the review requirements of the King’s College London Research Ethics Committees, you will instead need to make an application through the King’s College London research ethics system accordingly. Click here for further details.
R & D approval
It should be noted that some studies that fall outside of the review requirements of the UK Health Departments Research Ethics Service will still also require approval/management permission from the host care organisations, often called ‘R&D approval’. The Department of Health’s Research Governance Framework for Health and Social Care (RGF) requires NHS organisations to ensure that before any research involving human participants, their organs, tissue or data commences, such approval/permission has been granted.
In most NHS organisations an R&D office or network is responsible for carrying out the relevant checks before permission is given by the chief executive or a delegated senior person. The standards in the Research Governance Framework are applied in all countries of the UK.
If you are in doubt as to which committee your application needs to be submitted to email the National Research Ethics Service in the first instance or contact the Research Ethics Office