HRA Approval is the new process for the NHS in England that brings together the assessment of governance and legal compliance, undertaken by dedicated HRA staff, with the independent Research Ethics Committee (REC) opinion provided through the UK Health Departments’ Research Ethics Service. 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.
It does not mean that NHS organisations are required to participate in studies where they are named as potential sites, but it does mean that the decision to participate will be made on local consideration of capacity and capability to deliver the study alone. While HRA Approval is the single approval for research in the NHS in England, there is still the requirement for researchers to engage with sites and for sites to confirm that they have all the arrangements in place in order to participate in the study.
From 31 March 2016, HRA Approval is the process for applying for approvals for all project-based research in the NHS led from England. HRA Approval applies only to the NHS in England. Studies with sites in Northern Ireland, Scotland or Wales will be supported through existing UK-wide compatibility systems, by which each country accepts the centralised assurances, as far as they apply, from national coordinating functions without unnecessary duplication.