All studies involving either diagnostic or therapeutic ionising radiation are to
be reviewed by a Medical Physicist.
Medical Physicist will provide a report that is used to determine
appropriate wording in the Participant Information and Consent Form about
exposures and risks and is used to advise on the reporting requirements of
the study to the Victorian Department of Health (DoH). The Medical
Physicist must sign Section 4 or the Victorian Specific Module
(VSM) for research projects involving exposure which is additional to
standard care. The hospital’s Radiation Safety Officer (RSO) must sign
Section 4 or the VSM for all projects involving ionising radiation, whether
the exposure is standard care or additional to it.
Obtaining a report from
a Medical Physicist should not be confused with completing Section4/VSM or obtaining medical imaging resource declarations (see
Imaging Services Guidelines).
Please note that there
is a fee for this service (see below).
Alfred Health Radiation Safety Officer:
Zoe Brady (03) 9076 2368 (email@example.com)
Queries relating to imaging resources in each area should be
Radiology services: Helen Kavnoudias on (03) 9076 3606
Nuclear Medicine and PET services:
Bruce Van Every on (03) 9076 2755
Robin Smith on (03) 9076 2360
that require a Medical Physicist Report
Diagnostic imaging: eg CT
scans, 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
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 RSO before proceeding)
All studies, regardless
of whether the procedures are part of routine clinical care or additional to
it, should complete
Section 4 or the
Victorian Specific Module (VSM).
If all the procedures are standard
(i.e. the patient would normally have the exact same procedure/s at the same
time in the course of their clinical care) complete Sections 1, 2 and 9 of
Section 4 or
Sections 4.1, 4.2 and 4.9 of the
If any of the procedures are ‘additional’
(i.e. outside of standard care – for example: increased frequency of imaging
or additional views) complete all sections of the relevant Module.
available to assist you to fill out
Section 4 or
researchers are responsible for the accuracy of the information provided. If
there is concern about whether procedures are standard or additional or
queries about the types of scans to be performed these can be discussed with
the relevant contact listed above.
all studies please complete the
Medical Physicist Report Request Form
Project and Principal Investigator
contact details for the researcher in the best position to answer
radiation procedure questions. This may be the principal investigator or
another nominated person on the study team.
Researchers are required to e-mail an electronic copy
of the following documents with their preliminary submission to the Alfred
Ethics & Governance Office:
firstname.lastname@example.org by the submission date.
The Alfred Ethics & Governance Office 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
What happens once the
Medical Physicist’s Report is completed?
The Medical Physicist’s
Report comprises a letter and updated Module 4 or VSM. The report is used to
determine if and what appropriate wording is to be inserted into the
Participant Information and Consent Form/s about exposures and risks and is
used to advise on the reporting requirements to the Radiation Safety
Section, Victorian Department of Health. You will notice that Module 4/VSM
has been signed by the Medical Physicist, if the radiation procedure is
additional to standard care, and the RSO.
If the dose constraints
have been exceeded, the Medical Physicist will arrange for a second Medical
Physicist to verify the initial dosimetry calculations performed.
The Medical Physicist
will send their report directly to the Alfred Ethics Office who will forward
it to the researcher.
It is then up to the
researcher to liaise with the Ethics 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
The Medical Physicist’s Report advises if the DoH
Radiation Safety Section should be notified. What does this mean and how
does that happen?
If the Medical
Physicist’s Report advises that the DoH must be notified:
Projects can only be notified to the DoH once they have been
given final approval by the Human Research Ethics Committee. If the Medical
Physicist’s Report advises that the DoH must be notified, then the Ethics
Office (not the researcher) will notify the DoH. The Ethics Office requires
an electronic copy of the final approved version of the Participant
Information and Consent Form to do so. Basic project details are then
provided to the DoH.
Once acknowledgement of the notification is received from the
DoH, you will be advised by the Alfred Ethics Office and can then commence
your project. You must not start your project
until this has occurred.
the Medical Physicist’s Report advises that the DoH does not need
to be notified:
You may commence your project when approval from the Human
Research Ethics Committee has been received.
e.g. external sponsorship, NHMRC funding or other funding
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
- Advice regarding radiation licensing and notification of the Victorian
Department of Health
Completion of Module
4/VSM (signed by Medical Physicist and Radiation Safety Officer, if
Payment of fees
fee for the Medical Physicist’s report will be due after completion of the
Please specify on the Medical Physicist’s Report Request Form if the
payments will be made from an Alfred Cost Centre or directly from the
sponsor. Include details of the person responsible for the
payment and if the fee is to be transferred from a cost centre.
This page was last modified
The Alfred 2000 - 2012