HRA Approval is the process for the NHS in England that brings together the assessment of governance and legal compliance. It replaces the need for local checks of legal compliance and related matters by each participating organisation in England. This allows participating organisations to focus their resources on assessing, arranging and confirming their capacity and capability to deliver the study. More information is available on their website.
Research Ethics Committee Review
Research Ethics Committee Review forms part of the HRA approvals process and ensures that research carried out in the NHS is ethically sound. It protects the rights, safety, dignity and well-being of research participants.
Amendments
Amendments should be handled in accordance with the UK National process, as defined by the HRA. Information about the process regarding amendments can be found on the Health Research Authority’s website.