What is required to be submitted for HREC review?
If the radiation exposure is Standard of Care
It is the responsibility of the trial site Principal Investigator to determine if radiation required for the trial forms part of standard of care for participants. If you are unsure please seek advice from Alex Merchant, Barwon Health Medical Physicist.
If the use of ionising radiation exposure is deemed standard of care, the site Principal Investigator completes a HREC Radiation Notification Letter (click to download). The letter must be provided to the Coordinating Principal Investigator for inclusion in the ethics application.
The HREC Radiation Notification Letter must be submtted to the HREC for review (signed by Principal Investigator) via ERM (Ethical Review Manager)
If the radiation exposure is additional to Standard of Care
For Single site studies: The PI must submit an independent radiation safety risk assessment by a Medical Physicist for review by the HREC in ERM. The assessment must include the effective dose, relevant organ doses, a risk assessment, and recommended text for the PICF.
For multi site studies: All sites must undergo an independent radiation safety risk assessment. However, the Coordinating PI only needs to submit one radiation safety risk assessment for the entire study for review by the HREC in ERM. Ideally this should be the highest site assessment dose available. The assessment must include the effective dose, relevant organ doses, a risk assessment, and recommended text for the PICF.
Both the Medical Physicists Risk Assessment Form (completed by the Investigator) and the Independent Radiation Risk Assessment Report from the Medical Physicist are required for submission to Barwon Health HREC. Other HRECs may request both, or the Report only.