Application for Ethical Review:
The Health Research Authority (HRA) facilitates ethical research that is of potential benefit to participants. The Research Ethics Service (RES) is a core function of the HRA. Whilst the majority of research conducted within the NHS requires ethical review, there are some important exceptions that can be identified by using the HRA Decision Tool.
Since March 2016, HRA Approval has been the process for applying for approvals for all project-based research in the NHS led from England. In April 2018 this has been extended to include all project-based research in the NHS in Wales, and HRA Approval is now referred to as ‘HRA and HCRW Approval’. Scotland and Northern Ireland have their own systems for ethics approval.
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. The Health Research Authority (HRA) and INVOLVE have developed a statement to provide further clarity.
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.