Regulatory approvals

The following types of regulatory reviews might be required for your research:

  • Gene Therapy Advisory Committee (GTAC): gene therapy clinical trial
  • Social Care Research Ethics Committee: social care research studies
  • Ministry of Defence Research Ethics Committee (MoDREC): research involving the UK armed forces
  • Higher Education Institution Research Ethics Committees: some studies undertaken by researchers in higher education institutions, typically those are not reviewed by NHS RECs
  • Confidentiality Advisory Group (CAG):  Research requiring access to confidential patient information without consent 
  • National Offender Management Service (NOMS): Research taking place in prisons and Probation Trusts
  • Administration of Radioactive Substances Advisory Committee (ARSAC): Research involving the administration of radioactive materials 
  • Human Fertilisation and Embryology Authority (HFEA): Research involving human embryos and gametes
  • Medicines and Healthcare Products Regulatory Agency (MHRA):
    • A Clinical Trial Authorisation (CTA) is required for any clinical trial of an investigational medical product (CTIMP) to be conducted in the UK that fall within the scope of the EU Clinical Trials Directive and the Medicines for Human Use (Clinical Trials) Regulations 2004
    • An application to MHRA Devices is required where the study is a clinical investigation of a medical device of a non-CE marked product or an investigation of a CE marked product that has been modified or is to be used outside its intended purpose

More information is available in our SOP below and on the NHS Health Research Authority website.