Research Involving the use of  Ionising Radiation

Where the procedures involving ionising radiation are in addition to standard clinical care the Medical Physicist/Radiation Safety Officer (RSO) must assess the ionising radiation component of the research project.

Where the use of ionising radiation is identical to that of standard clinical care the research proposal only requires to be verified/signed off by the Medical Physicist / Radiation Safety Officer (RSO).

Examples where ionising radiation may be used include:

• Diagnostic Radiographic procedures:
  (i.e. Plain film radiography, fluoroscopy, interventional radiography (angiography), CT examinations and DEXA scans).
• Nuclear Medicine procedures:
  (i.e. The in vivo application of unsealed radioactive sources)
• Therapeutic procedures:
  (i.e. The use of ionising radiation for radiotherapeutic purposes)

Researchers should make an appointment (by telephone) with the relevant RSO (for procedures involving the use of x-rays or unsealed radioisotopes) for a brief interview. Information to be provided to the RSO, either by e-mail or in hard copy, at least 3 days prior to the interview is:

• A copy of the research protocol;
• A copy of the Patient Information and Consent Form (PICF);
• Copies of the DHS/HREC Modules (including Module 4);
• A summary of the type of ionising radiation proposed to be used, with a detailed description of the radiation procedures involved and any special requirements as outlined in the research project;
• Whether the research group involves volunteers and/or patients;
• Whether students or staff are involved;
• An indication of whether each radiation procedure is part of standard clinical care.

The Radiation Safety Officer/Medical Physicist will be able to assist you with the radiation dose, risk category, inclusion of a statement of the radiation risks involved and how this risk compares with everyday risks in the Patient Information and Consent Form (PICF).

The Radiation Safety Officer/Medical Physicist will:

• Make an assessment of the radiation dose;
• Determine the relevant category of risk;
• Produce the recommended statement outlining the risks associated with the radiation exposure to be included in the Plain Language Statement and Consent Form; and
• Advise on the appropriate approvals required, for example, licence approvals from the Victorian Regulatory Authority - Department of Human Services - Radiation Safety Program.

Contacts

Mr Paul Einsiedel
Medical Physicist and Radiation Safety Officer
Department of Radiology
The Royal Melbourne Hospital
Telephone: 03 9342 8378
Email: paul.einsiedel@mh.org.au

Dr Nouria Salehi
Department of Nuclear Medicine
The Royal Melbourne Hospital
Telephone: 03 9342 7265
Email: nouria.salehi@mh.org.au

NOTE:
A fee may apply for assessment of research projects by the Medical Physicist/Radiation Safety Officer. The cost of the assessment takes in account the time required to assess the radiation dose, providing the relevant risk statements, reviewing the research against the relevant Code of Practice and preparing the advice. You should confirm any costs with the Medical Physicist/Radiation Safety Officer prior to an assessment being carried out.

Regulatory requirements from the Department of Human Services - Radiation Safety Program

The Health Act 1958 and Health (Radiation Safety) Regulations 1994 control all uses of ionising radiation in Victoria, and include a system requiring the licensing of operators of radiation equipment and radioactive sources, and the registration of irradiating apparatus and sealed radioactive sources. There are specific licensing requirements related to research projects involving irradiation of human volunteers where the procedures involving the use of ionising radiation are deemed not to be of potential benefit to the participants or the radiation exposure is in addition to standard clinical care. In these cases approval from the Department of Human Services - Radiation Safety Program is required; the RSO will be able to advise you if you need to make an application to the Department of Human Services. This approval is in addition to the approval normally obtained from the institution's ethics committee.

The Department of Human Services may refer applications to the Radiation Advisory Committee (RAC) for their consideration. The RAC is an independent advisory body to the Minister of Health on radiation related matters. As part of that responsibility the RAC reviews and recommends the approval of research projects that expose volunteers to ionising radiation.

The RSO will be able to provide you with contact details and information required to be submitted to the Department of Human Services if their approval is required.

All human research protocols involving the use of ionising radiation on either patients or volunteers must have written approval from the Medical Physicist/Radiation Safety Officer and the Human Research Ethics Committee BEFORE the project is initiated. Where applicable, approval also needs to be obtained from Department of Human Services.