Regulatory approvals

• Research Ethics Committee (REC)
o A Research Ethics Committee (REC) is an independent committee that considers the ethics of applications to conduct health or social care research in the UK. The studies will involve human participants, and most will take place within the NHS. The research proposal cannot proceed without the approval of the REC.

• Administration of Radioactive Substances Advisory Committee (ARSAC)
o ARSAC advises the licensing authorities on applications from practitioners, employers and researchers who want to use radioactive substances on people.

• Confidentiality Advisory Group (CAG)
o The Confidentiality Advisory Group (CAG) is an independent body which provides expert advice on the use of confidential patient information.

• Gene Therapy Advisory Committee (GTAC)
o Gene Therapy Advisory Committee (GTAC) is the UK national Research Ethics Committee (REC) for gene therapy clinical research. The committee oversees the ethical aspects of gene therapy clinical trials and to advise the government on developments in gene therapy research.

• Medicines and Healthcare products Regulatory Agency (MHRA)
o Medicines and Healthcare products Regulatory Agency. MHRA (Medicines) is the competent authority for the UK in relation to the EU Directive and the Clinical Trials Regulations. MHRA (Devices) is the competent authority for the UK in relation to the Medical Devices Regulations 2002.