Regulatory approvals are required for all research studies being conducted within CNTW, and different studies will require approval from different regulatory bodies.
Health Research Authority (HRA) Approval
HRA approval applies to all research taking place in the NHS throughout England and Wales. All research projects being conducted at CNTW, and not using the CNTW student process, require HRA Approval.
HRA approval applies where an NHS organisation has a duty of care to participants, which includes projects where participants are service users, carers, or staff. More information on the HRA approval process and its requirements can be found on the HRA website here.
Research Ethics Committee (REC) Approval
REC approval is necessary when a research project involves NHS participants, and the REC will review research proposals to give an opinion on whether the project is ethical. The committees are independent of research Sponsors, funders, and the research teams, which enables them to prioritise participants irrespective of other factors.
More information on REC Approval can be found here.
Confidentiality Advisory Group (CAG) Approval
The Confidentiality Advisory Group (CAG) is an independent body which advises the HRA on the use of confidential patient information. The CAG determines appropriate use of patient information to inform research projects while maintaining the interests of patients and the public.
More information on CAG approval can be found on the HRA Website here.
Medicines and Healthcare products Regulatory Agency (MHRA) Approval
The MHRA regulates medicines, medical devices, and blood components for transfusion in the UK on behalf of the Department of Health and Social Care.
The MHRA have an algorithm available which will help you to identify if your project is a CTIMP and requires a Clinical Trial Authorisation, or a Non-Interventional Clinical Trial.
More information on MHRA Approval can be found here.