If you are planning to conduct a trial using a gene therapy product, ethical approval from the Gene Therapy Advisory Committee (GTAC) is required. The GTAC definition of gene therapy is "The deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes." This includes techniques for delivering synthetic or recombinant nucleic acids into humans.
Ethics Submissions
Multi-centre research applications
Are required for multi-centre studies (on two sites or more), except those where all sites are within the same domain
Site specific assessment
Are required when you are applying to a local REC for site-specific assessment only.
- Type 1 RECs – recognized for review of phase I Clinical Trials of Investigational Medicinal Products (CTIMPs) in healthy volunteers only. Some Type 1 RECs are independent ethics committees (ie non-NHS IECs).
- Type 2 RECs – recognized for review of Clinical Trials of Investigational Medicinal Products (other than phase I trials in healthy volunteers) taking place within a single domain
- Type 3 RECs – recognized for review of Clinical Trials of Investigational Medicinal Products (other than phase I trials in healthy volunteers) and all other research taking place in more than one domain anywhere in the UK.
