Radiation & laser safety
All studies at Alfred Health involving either diagnostic or therapeutic ionising radiation exposure of human participants are to be reviewed by a Medical Physicist, regardless of whether the procedures are part of routine clinical care or additional to it.
The information below describes how to obtain a Medical Physicist report. There is a fee for this service.
Obtaining a report from a Medical Physicist should not be confused with obtaining a signed diagnostic imaging and radiotherapy service declaration for use of hospital resources for research.
Procedures that require a Medical Physicist Report
Ionising radiation procedures:
- Diagnostic imaging: eg CT scans (including CT guided biopsies), DEXA scans, plain x-rays, fluoroscopy (eg PICC line insertion under fluoroscopy guidance) and angiography
- Nuclear medicine: all scans, including Positron Emission Tomography (PET) and Gated blood pool scans (MUGA)
- Other: tritiated noradrenaline infusions
Non ionising radiation procedures:
- Magnetic Resonance Imaging - (MRI)
If a person presents for a MRI and there is any concern about metallic foreign bodies during MRI screening, plain X-rays will be performed prior to the MRI. As x-rays are an ionising radiation procedure, a Medical Physicist report is required. Only projects where researchers have agreed to exclude the MRI being performed in the event of possible metallic foreign bodies, will the report not be required. This must be stated in the Ethics Application.
- Lasers (please contact the Radiation Safety Officer before proceeding)
Researchers are required to e-mail the following documents to firstname.lastname@example.org
- Medical Physicist Report Request Form
- Victorian Medical Physics Risk Assessment Form (MPRA)
- Imaging protocol if different from standard hospital imaging protocol
- Participant Information and Consent Form/s
For projects reviewed by the Alfred Hospital Ethics Committee, report requests should be at or before the time of project registration.
For projects reviewed by an external Ethics Committee, report requests should allow sufficient time for the report to be completed and submitted to the external Ethics Committee for approval, which is well before site specific application assessment.
The Office of Ethics and Research Governance will organise for the Medical Physicist's report to be completed.
You may be contacted by the Medical Physicist undertaking the report if they have any queries.
How long does it take for the Medical Physicist's report to be completed?
Requests for Medical Physicist's reports will be processed within ten working days from when all documents listed above are submitted.
What is included in the Medical Physicist's report?
The Medical Physicist will provide a report including:
- The proposed text on the radiation doses and risks to be included in the Participant Information and Consent Form/s
- Dose estimate and a statement as to whether dose constraints are likely to be exceeded for only those radiological procedures which are performed specifically for the research protocol and which would not form part of the research participant's normal clinical management
- If the dose constraints have been exceeded, the Medical Physicist will arrange for a second Medical Physicist to verify the initial dosimetry calculations performed
- A risk assessment for consideration by the Ethics Committee
- Advice on the reporting requirements of the study to the Victorian Department of Health and Human Services (DHHS)
Attached to the report will be a signed Appendix 1.7a of the MPRA form (if the research is being conducted under the authorisation on the Alfred Health Radiation Management Licence).
What happens once the Medical Physicist's report is completed?
The Medical Physicist will send his/her report directly to the Office of Ethics & Research Governance and the researcher.
It is then up to the researcher to liaise with the Office to ensure any recommendations are met. If the Participant Information and Consent Form/s need to be altered the Medical Physicist will provide the additional wording to be substituted.
If the Medical Physicist's report advises that the DHHS must be notified, the project can only be notified to the DHHS once the project has ethics approval and authorisation by Alfred Health. The Office of Ethics and Research Governance (not the researcher) will notify the DHHS.
Internal non-funded trials and internal NHMRC funded trials: $200 (excluding GST)
Externally sponsored and other funded trials: $550 (excluding GST)
This fee includes:
Medical Physicist's report and if radiation protocol is additional to standard care:
- Estimate of effective dose.
- Assessment against dose constraints.
- Assessment of risks associated with the exposure.
- Proposed text on the radiation doses and risks to be included in the Participant Information and Consent Form/s.
Advice regarding radiation licensing and notification of the DHHS.
Completion of Appendix 1.7a of the MPRA (signed by the representative of the Radiation Management Licence holder, if applicable).