Ethics Procedures for Research Involving the NHS
Research involving NHS patients, staff, information or facilities is subject to local and national level ethical review. The National Research Ethics Service (NRES) oversees the overall structure and operation of research ethics governance across the UK. Local Research Ethics Committees (LRECs) across the UK - 8 in Wales - serve specific regions and are responsible for reviewing university research projects. Multi-Centre Research Ethics Committees (MRECs) - 1 in Wales - review large scale multi-centre clinical research projects.
When to Apply for Ethics Review by an NHS Research Ethics Committee
Ethical approval from the appropriate NHS REC is required for any research proposal involving NHS resources or any clinical trial of a medicinal product under the Medicines for Human Use (Clinical Trials) Regulations 2004. Researchers should refer to the relevant Research Governance Process which outlines the necessary approvals required before a research project can commence.
For guidance on the ethical review of Research, Clinical Audit and Service Evaluation, including definitions, please refer to the additional guidance prepared by the NHS Research and Development Forum in the Related Resources. If you require further clarification, it is recommended that you contact one of the coordinators of the South East Wales Research Ethics Committees .
It is the responsibility of the Principal Investigator (PI) to follow the ethical review flowchart (below) and the MHRA clinical trial algorithm, to ascertain whether the study is indeed a clinical trial. If clarification is still required for the category of the study, the PI should contact the MHRA directly. Please note: if the Chair of a SREC (or other University ethical review body) has any concerns regarding whether a study should be reviewed by the NHS system (in view of the type of study, category of the participant e.g. healthy volunteer, NHS patient, participant from a database), he/she should discuss the study with the Chair of the appropriate NHS ethics committee. Please note that if a research project has not received specific ethical approval via the NHS system, it may fall under the Human Tissue Act.
Ethics Review Options Flowchart
Click on the link below to see a full-sized version of the Ethics Review Options Map (updated August 2011) which details the relevant processes to follow, depending on the nature of your research (also summarised below).
Governance Arrangements for Research Ethics Committees (GAfREC) harmonised edition 2011
The following points have been made by the Welsh Assembly Government and have been provided at the request of Cardiff University. The main changes which have been made to the final harmonised edition are summarised as follows.
Research should be submitted to an NHS REC if:
• a REC review is required by law, whether or not it is ‘NHS Research’;
• it includes social care research projects funded by the Department of Health;
• it includes patients who are cared for in private and voluntary sector nursing homes.
Research involving the following should now be submitted to a School Research Ethics Committee (SREC):
o NHS premises and facilities (please note that NHS R&D approval will still be required for this);
o Non-identifiable patient data;
o A-cellular material and non-identifiable tissue (except where consent for research is not in place or review is otherwise required by the Human Tissue Act);
o NHS staff in their professional role.