The role of the Health Research Authority (HRA) is to protect and promote the interests of patients and the public in health research and to streamline the regulation of research. The HRA is also responsible for the NHS Research Ethics Committees.
HRA approval is the approval that is be required for all research in the NHS in England. It is a process that comprises of a review by a research ethics committee (REC) as well as an assessment of regulatory compliance and related matters undertaken by staff of the HRA located in centres around England.
HRA approval includes a study-wide review in line with UK-wide agreed standards and also new assurances including the coordination of clinical support assurances for radiation and pharmacy. Once HRA approval is in place and local capacity and capability is agreed, sites will be able to confirm with the sponsor their readiness to recruit and the study will be able to start at that site.
Applications for HRA approval are made using IRAS (integrated research applications system) and are e-submitted directly to the HRA through IRAS. Study documents to sites are to be provided directly from the sponsor.