Download Alfred Health Radiation and Laser Safety

Alfred Health Radiation and Laser Safety
All studies involving either diagnostic or therapeutic ionising radiation are to be reviewed by a Medical
Physicist.
The 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 and Human Services
(DHHS). 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 hospitals 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 Radiology & Nuclear Medicine Guideline: Services
for Clinical Trials).
Please note that there is a fee for this service (see below).
Alfred Health Radiation Safety Officer: Amanda Perdomo (03) 9076 2368
([email protected])
Queries relating to imaging resources in each area should be directed to:
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Radiology services: Helen Kavnoudias on (03) 9076 3606
Nuclear Medicine and PET services: Martin Cherk on (03) 9076 2451
Radiotherapy services: Robin Smith on (03) 9076 2360
Procedures that require a Medical Physicist Report
Ionising radiation procedures:
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Radiotherapy
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 scans (MUGA)
Other: tritiated noradrenaline infusions
Non ionising radiation procedures:
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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)
Forms
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 VSM.
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.
There are guidelines available to assist you to fill out Section 4 or VSM.
Note - 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.
For all studies please complete the Medical Physicist Report Request Form
This clearly identifies:
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The Project and Principal Investigator
The 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.
Billing information.
Submission process
Researchers are required to e-mail an electronic copy of the following documents with their
preliminary submission to the Alfred Ethics & Governance Office:
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Medical Physicist Report Request Form
Section 4 (see Section 4 Guidelines) or VSM (See VSM Guidelines)
Protocol
Imaging protocol if different from standard hospital imaging protocol
Participant Information and Consent Form
Radiology, nuclear medicine & radiation oncology services 'Declaration from Resource
Centre Manager'
to: [email protected] by the submission date.
The Alfred Ethics & Governance Office will organise for the Medical Physicists 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 Physicists Report to be completed?
Requests for Medical Physicists reports will be processed within ten working days.
What happens once the Medical Physicists Report is completed?
The Medical Physicists Report comprises a letter and updated Section 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 and Human Services. You will notice that
Section 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 substituted.
If the Medical Physicists 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.
Fees
Internal non-funded trials:
$100
Funded trials:
$400
e.g. external sponsorship, NHMRC funding or other funding
This fee includes:
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Medical Physicists 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 and Human Services
Completion of Section 4/VSM (signed by Medical Physicist and Radiation Safety
Officer, if applicable)
Payment of fees
The fee for the Medical Physicists report will be due after completion of the report.
Please specify on the Medical Physicists 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.