Ionising Radiation

The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Radiation Protection Series is a regulatory set of fundamentals, codes and standards, guides and recommendations designed to manage the risks associated with ionising radiation. The Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) is a regulatory code designed to ensure researchers who propose to expose research participants to ionising radiation provide the Human Research Ethics Committee (HREC) and participants with information that allows informed consent to be appropriately considered by the HREC and the participants.

Read the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research

Ionising radiation procedures

The management of risks from ionising radiation relies on the principles of protection, safety and security. The following ionising radiation procedures require additional oversight during the ethical review and research governance approvals process to manage the risks for patient safety and health:

• Radiotherapy
• Diagnostic Imaging: X-Rays, CT scans, fluoroscopy, angiography, DEXA scans,
• Nuclear Medicine: all nuclear medicine scans including PET, SPECT and MUGA scans

The radiation exposure of ionising radiation procedures is site-specific, as different machines may deliver different amounts of radiation and standard of care procedures may differ between sites.

Ethical approval

All research projects that involve the use of ionising radiation procedures must submit the following additional documentation for each participating site to the Metro North HREC for review:

Ionising radiation procedures additional to standard clinical care

Research projects involving the use of ionising radiation procedures that are considered additional to standard clinical care must address the following additional information requirements in the application to the Metro North HREC for ethical review:

• the reasons why it is necessary to expose research participants to ionising radiation for the purpose of the research
• a statement confirming that the site at which the examination or procedure will be performed is actively involved in a relevant quality assurance program such as the programs of the Royal Australian and New Zealand College of Radiologists or of the Australian and New Zealand Association of Physicians in Nuclear Medicine
• the precautions to be taken to keep radiation exposure to a minimum
• the written information to be given to research participants relating to the doses and risks associated with the radiation exposure
• for novel uses of radiation, the arrangements for a review of radiation doses actually received and the arrangements for retention of dose records

This information is to be included in the Human Research Ethics Application (HREA), research protocol, Participant Information and Consent Form (PICF) and any associated research project study documentation as most appropriate for the application.

Research governance

All research involving the use of ionising radiation procedures at a Metro North facility must receive site authorisation prior to commencing. The Metro North research governance office will review any site-specific documentation related to ionising radiation, including the PICF.

The site-specific PICF must include the approved ionising radiation information exactly as it is contained in the Radiation Dose and Risk Assessment Report and be submitted via ERM for governance review.

Quotes for services

All quotes for services (e.g. radiology or nuclear medicine) must be submitted via ERM for research governance approval. This includes both ionising radiation procedures and non-ionising radiation procedures, such as MRI.

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