Please click here to read more about the main regulatory approvals which may be required.
Please see below for further information about all of the regulatory bodies you may need to consider.
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Gene Therapy Advisory Committee (GTAC) for gene therapy clinical trials – this is now incorporated into HRA approval. Please note that applications need to be booked for review by GTAC.
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Confidentiality Advisory Group (CAG) - this is now incorporated into HRA approval. Please note that applications need to be booked for review by CAG. You can also apply separately to CAG as some studies may need CAG approval but not HRA approval.
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Research Ethics Committee (REC) – this is now incorporated into HRA approval. Please note that applications still need to be booked for review by the REC. There are also separate Research Ethics Committees for social care studies, for studies sponsored or funded by the Ministry of Defence, and within Higher Education Institutions. Click on the links to find out more if you think these may be appropriate for your study.
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Medicines and Healthcare products Regulatory Agency (MHRA) – Medicines - this is required for any Clinical Trials of Investigational Medicinal Products (CTIMPS)
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Medicines and Healthcare products Regulatory Agency (MHRA) – Devices - this is required for clinical investigations of medical devices.
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Administration of Radioactive Substances Advisory Committee (ARSAC)
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National Offender Management Service (NOMS) – required for any studies with prisons (including YOIs) or probation trusts.
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Human Fertilisation and Embryology Authority (HFEA) for research involving human embryos and gametes.
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Human Tissue Authority (HTA) which approves organisations which store human tissue for research.
See also
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Health Research Authority (HRA) - e-learning
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Bradford Institute for Health Research - information for researchers