HRA approval

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 new approval that will be required for all research in the NHS in England. It is a new 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 will include 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. When HRA approval is fully implemented, sites will have to confirm they have the capacity and capability to undertake the study. 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 will be provided directly from the sponsor for most study types. HRA studies will not appear in the NIHR CSP module.

Further information will be distributed via the research and development team as it becomes available. In the meantime you can subscribe to HRA communications to receive the latest developments from the HRA. Guidance is also available on the HRA website, with new documentation being added as the cohort roll-out continues. This includes guidance for applicants, guidance for NHS organisations, illustrative examples (including the new Statement of Activities) and opportunities to provide feedback to the HRA.

The research and development department is currently updating all the policies and guidance pertaining to study approval, set up and sponsorship where impacted by this new HRA authorisation process. Details of the updated documents will be shared with all trust researchers in due course and made available in the SOP section of our webpages.

Please feel free to contact the research and development team on rf.randd@nhs.net or call ext 38900 if you have any further questions or wish to discuss any aspect of the HRA approval in more detail.