Once Radiation Assurance is confirmed, it is the applicant’s responsibility to copy the Lead MPE and CRE reviews, provided in the research exposure form, into Part B Section 3 in IRAS. The reviewers will ensure that any changes they have requested to the participant information sheet (PIS) have been made before they authorise the IRAS form. Authorisations can then be requested from the Lead MPE and CRE.
The HRA will notify the REC that the application has Radiation Assurance so that it can be assured that appropriate information is in place regarding the research exposures. If applying to the Administration of Radioactive Substances Advisory Committee (ARSAC), the applicant should include the email confirming Radiation Assurance is in place, together with the research exposure form. The applicant should also share this confirmation email and the research exposure form with participating NHS/HSC sites as part of the local information pack.
Participating NHS/HSC sites can use the research exposure form to aid their capacity and capability assessments. Additionally, sites can be assured that there is clear and consistent information about the risk of ionising radiation exposure in the participant information sheet (PIS) and IRAS review, which will have been completed to national standards. This means that sites will not need to review the risk information contained in these documents.
Lead MPEs conducting reviews through Radiation Assurance will use the HRA’s standardised guidance to conduct the review. This includes using nationally accepted references to calculate doses. Doses which are calculated using different references may need to be calculated again locally, particularly where the Lead MPE reviewer has noted that they have used their own local data. Doses calculated using the references contained within the MPE Review Procedure do not need to be repeated at a local level.
Sites will still need to meet local requirements under the Ionising Radiation (Medical Exposure) Regulations (IRMER). This includes, but is not limited to:
- ensuring that appropriate ARSAC licences are in place, where required
- IRMER Practitioners justifying each exposure to each participant
- ensuring that participants participate voluntarily in the research
- fully informing participants of the risks of the exposure(s)
- ensuring that where there is no direct medical benefit expected from the exposure, the dose constraint set down locally is adhered to
- IRMER Practitioners planning individual target levels of doses for participants who undergo an experimental research exposure from which they are expected to benefit.
If the research exposures which have been reviewed through Radiation Assurance change at any point, they will need to be submitted as an amendment. Guidance on how to submit amendments through Radiation Assurance is available on the IRAS website.
Sponsors and sites can also contact the technical assurances team to provide feedback on the Radiation Assurance process and the guidance we have provided.