Ethics Submission follows the CTA Submission station and precedes the R&D Submission station. The process occurs in parallel with CTA Submission and R&D Submission. Ethics Submission is a legal requirement which is relevant to all trials. This station is part of the ‘trial approvals phase’ group of stations.
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.
Health Research Authority Approval (HRA Approval) and Health and Care Research Wales Approval (HCRW Approval) are the processes for applying for approvals for all project-based research in the NHS led from England and Wales. Scotland and Northern Ireland have their own systems for ethics approval. Learning resources for HRA Approval can be accessed here.
Combined ways of Working Pilot
The HRA and MHRA are piloting a single CTIMP application dossier to be submitted for both the Clinical Trial Authorisation (CTA) and the Research Ethics Committee (REC) opinion.
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.