Regulatory Approvals and Ethical Review

• A sponsor – an organisation which takes responsibility for ensuring the proper approvals and arrangements are in place to ensure research can be delivered efficiently and effectively. 
• National Approval (As applicable) – not all studies will require the same approvals, and different regulatory bodies have distinct roles and responsibilities in reviewing studies depending on the activities conducted. More information about regulatory bodies can be found below or via the Integrated Research Application System (IRAS) help page. The two most common reviews and approvals required for research delivered in the NHS is:
• Research Ethics Committee approval.
• Health Research Authority approval.
• Local hosted approval – this is the approval from the organisation that will be delivering the research on their site and with their staff/ patients. Confirming that a local trust can deliver a research study is called receiving capacity and capability (C&C).
• Funding – this can be internal or external. Studies with funding are often on the National Institute of Health Research (NIHR) portfolio, which allows the Research Delivery Team (RDT) to support locally. When a study has no funding for delivery, the project will be mainly clinician delivered, but the Research Support Team (RST) will be able to provide guidance if needed.

Regulatory Bodies

• Research Ethics Committee (REC). 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). ARSAC advises the licensing authorities on applications from practitioners, employers and researchers who want to use radioactive substances on people.
• Confidentiality Advisory Group (CAG). 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). 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). 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.