Application for Ethical Review:
In the UK, the Health Research Authority (HRA) exists to protect the rights, safety, dignity and well-being of research participants whilst facilitating ethical research that is of potential benefit to participants, science and society. This is achieved through the review of research taking place within the NHS by NRES Research Ethics Committees (RECs). RECs give their opinion about the proposed participant involvement and whether the research is ethical. Whilst the majority of research conducted within the NHS requires ethical review (see the Governance Arrangements for Research Ethics Committees - A Harmonised Edition for details), including all research involving NHS patients, there are some important exceptions*.
*For exceptions to the requirement for ethical review see the HRA Decision Tool
For all Clinical Trials of Investigational Medicinal Products (CTIMPs), the legal requirement for ethical review is set out in Part 2 of The Medicines for Human Use (Clinical Trials) Regulations. Application to NHS RECs should be made using the Integrated Research Application System (IRAS) (see also IRAS station for more information).
Patient and Public Involvement (PPI):
Ethics Committees will consider researcher’s plans for PPI as part of the ethical review process. N.B. Specific ethical approval does not need to be sought when involving the public in trial design and management activities.
Ethical Approval of Projects Involving Gene Therapy and certain other types of research:
Applications for ethical approval of a gene therapy clinical trial must be made to the Gene Therapy Advisory Committee (GTAC) which is the national REC for gene therapy clinical research according to regulation 14(5) of The Medicines for Human Use (Clinical Trials) Regulations 2004. Details of the application process can be found on the HRA pages for the Gene Therapy Advisory Committee.
The UK Stem Cell Tool Kit gives further guidance on the legislative requirements and processes for clinical trials of stem cell therapies.
The Experimental Medicine Tool Kit provides further guidance on the legislative requirements for experimental medicine* studies in the UK.
*Experimental medicine is defined as ‘Investigations undertaken in humans, relating where appropriate to model systems, to identify mechanisms of pathophysiology or disease, or to demonstrate proof-of-concept evidence of the validity and importance of new discoveries or treatments.’
Since 2014, the HRA have been publishing research summaries of all new research approved by a NHS REC, usually within 90 days of the REC opinion. Further information can be found on the HRA web pages.