Regulatory approvals

Differing regulatory approvals are required depending on your study type, information about different study types is available here but may include the following:
  • Gene Therapy Advisory Committee (GTAC): gene therapy clinical trial
  • Social Care Research Ethics Committee: social care research studies
  • Higher Education Institution Research Ethics Committees: some studies undertaken by researchers in higher education institutions, typically those are not reviewed by the HRA
  • 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

Further information is available from our Research Support Service; Noclor and HRA approvals - what approvals do I need
Last updated13 Mar 2020
Working on it!