Research & Ethics Unit

 Radiation & laser safety
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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 (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 (z.brady@alfred.org.au)

Queries relating to imaging resources in each area should be directed to:

  • Radiology services: Helen Kavnoudias on (03) 9076 3606
  • Nuclear Medicine and PET services: Bruce Van Every on (03) 9076 2755
  • Radiotherapy services: Robin Smith on (03) 9076 2360

Procedures that require a Medical Physicist Report

Ionising radiation procedures: 

  • 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:

  • 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)

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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:

  • 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:

to: research@alfred.org.au 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 working days.

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 substituted.

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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.

  • If 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.

Fees

Internal non-funded trials:                                                                               $100 

Funded trials:                                                                                                  $400

e.g. external sponsorship, NHMRC funding or other funding    

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
    - 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 applicable)

Payment of fees

The fee for the Medical Physicist’s report will be due after completion of the report. 

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.

 

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This page was last modified on 14/03/12

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