It is a requirement of the Medicines (Administration of Radioactive Substances) Regulations 1978 that administrations of radioactive medicinal products to humans should be conducted under certificates issued by the Health Ministers. For research studies where radioactive medicinal products are used, a research certificate is usually required for an applicant at each of the sites participating in the study.
Applications to ARSAC are prepared in the Integrated Research Application System (IRAS). The application process is in two stages:
Project level application
The ARSAC Preliminary Research Assessment (PRA) form is automatically generated in IRAS when the project filter has been completed to indicate that the study involves the administration of radioactive materials. The ARSAC PRA form may be submitted to the ARSAC Support Unit as soon as the application for ethical review has been submitted to the NHS REC.
Site level applications to ARSAC for individual research certificates
An ARSAC Research Certificate Application (RCA) is automatically generated in IRAS for each for site (i.e. for each site specific information form generated). The RCA may be submitted once the Preliminary Research Assessment form has been submitted. Note the first RCA may be submitted alongside the PRA form.
We have developed comprehensive guidance on the approval of research involving ionising radiation in consultation with ARSAC, the Health Protection Agency, the NHS R&D Forum and the professional bodies.