Radiation Assurance is a UK-wide process fully managed by the HRA on behalf of all four UK nations.
The process clarifies the information regarding radiation exposures in study documentation at an early stage in the research regulatory approvals pathway.
It also coordinates the lead Clinical Radiation Expert (CRE) and lead Medical Physics Expert (MPE) reviews in Part B section 3 of the Integrated Research Application System (IRAS) application form.
We receive ongoing expert input through the Four Nations Radiation Assurance Working Party, which consists of representatives from the HRA, the Administration of Radioactive Substances Advisory Committee (ARSAC) and radiation experts from all four UK nations.
Radiation Assurance will be a component of HRA and HCRWApproval for studies taking place in England and Wales once a phased implementation is completed. Until then, Radiation Assurance will remain a separate process.
Can I submit for Radiation Assurance?
Radiation Assurance accepts cardiology, oncology, neurology and rheumatology studies taking place in the NHS (or HSC in Northern Ireland).
What are the benefits of this process?
Radiation Assurance has been designed to:
- identify any inconsistencies or omissions in applications at an early stage
- give you greater clarity about the information needed to enable IRAS authorisations and site set-up to progress
- provide you with better support, by identifying the experts with the correct specialist knowledge to conduct the reviews
- give you and Research Ethics Committees (RECs) the assurance that the information provided in the IRAS authorisation contains all of the required information, to a set standard
- reduce site set-up times by providing higher quality information and thus reducing queries
- make it easier for participants to understand the risks of exposure to ionising radiation by using generic risk statements in participant information sheets
- set a standard research cost for the completion of authorisations within a new payment framework, making it easier for sponsors to request the correct amount of funding.