Projects Involving Ionising Radiation
When do we need a radiation report?
As depicted in the flow chart below, the submission requirements for radiation reports differ, depending on the level of radiation exposure.Please note, it is a requirement that notification of the study be made to the Department of Health and Human Services. This notification will be made by the Radiation Safety Officer within 14 days of Site Specific Authorisation being granted and the project may commence.
Do we need radiation reports for each site, if we are submitting a multi-site project to the Monash Health HREC?
Radiation exposure is site specific, whilst different machines do deliver slightly different amounts of radiation, the variability between sites is more about the assessment of whether the level of radiation exposure is standard of care at that site.
Upon submission of a multi-site project, Monash Health HREC requires submission of a notification letter (exposure not above standard of care) or a medical physicist report (exposure above standard of care) from the site with the highest radiation dose. When considering the balance of risk and benefit, the HREC bases its review on the highest dose.
This requires the Coordinating Principal Investigator (CPI) or delegate to provide the HREC with an assurance that they have received a radiation risk assessment from each participating site and have determined which site has the highest dose. If the CPI or delegate has not received a radiation risk assessment from all participating sites, they will not be able to give this assurance or submit the application for HREC review.
How do I obtain a Radiation Report when Monash Health is a participating site?
To obtain a medical physicist report for Monash Health, please email email@example.com and provide:
- Completed Section 4 of the Victorian Specific Module (VSM)
- Medical Physicist Report Request Form
- Draft Participant Information and Consent Form (PICF)
- Study Protocol.
Where can I find a Radiation Notification Letter if the radiation exposure is Standard of Care?
This letter can be found at the bottom of this webpage. Please ensure the Radiation Notification Letter is signed by the Principal Investigator prior to submission.
What is the Radiation wording requirement for Participant Information and Consent Forms?
- The master version of the Participant Information and Consent Form (PICF) will usually include a placeholder for the statement of risk to be inserted at local site level.
- The language in the PICF is site-specific, just as the medical physicist report/notification letter is site-specific. This is due to differing assessments by participating institutions as to the level of radiation exposure involved, and differing assessments of which exposures constitute “standard care”, and which are additional exposures.
- The HREC does not determine the statement of risk in the PICF, rather, the statement of risk should be taken from the medical physicist report and inserted word-for-word in the site-specific PICF.
- At local site level at Monash Health, where radiation exposure is not above standard of care, the following statement would be acceptable to insert in the Participant Information and Consent Form:
“This research project involves exposure to a small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation and receives a dose of about 2 millisieverts (mSv) each year. The effective dose from this research project is considered to be the same as standard of care – the amount you would receive if you were not on this trial. The dose from this research project is comparable to that received from many diagnostic medical x-ray and nuclear medicine procedures.”