The Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) is designed to ensure that researchers proposing to expose research participants to ionizing radiation provide information that allows consent to be properly considered by research participants and Human Research Ethics Committees.
Section 2.1.7 of the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) Code of Practice: Exposure of Humans to Ionising Radiation for Research Purposes states
“The researcher must prepare a submission to the Human Research Ethics Committee (HREC) in accordance with its requirements. The submission must include the following information regarding radiation exposure:
- the reasons why it is necessary to expose research participants to ionising radiation for the purpose of the research
- the radiation dose assessment and risk assessment made by a Medical Physicist
- 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
Please note the following requirements for submission of research projects to the MH HREC
Section 4 of the Victorian Specific Module (VSM) must be completed for each Victorian site. For example: If there are two Victorian sites then each site must submit their own Section 4 of the VSM pertaining to the respective sites.
Studies which include procedures involving exposure to ionising radiation deemed to be Standard Care: Notification to the Reviewing HREC for the use of Ionising Radiation in Research - Standard Care Form to be completed and signed by the Site Principal Investigator for each site.
All sites – VIC/QLD/NSW/SA/WA
Studies which include procedures involving exposure to ionising radiation deemed to be Additional to Standard Care at any of the participating sites:
- Submit a Medical Physics Radiation Dose and Risk Assessment for each site at which the radiation is deemed to be additional to standard care. (See requirements of Medical Physics Radiation Dose and Risk Assessment)
- If the Medical Physics report indicates that the radiation dose has exceeded the dose constraints as outlined in the National Code of Practice, verification of the dose calculations must be undertaken by a second Medical Physicist. This is the responsibility of the medical physicist.
Minimum requirements for medical physics radiation dose and risk assessment
Medical Physics Radiation Dose and Risk Assessment must be completed by a medical physicist and include the following information:
- Name of the site for which the assessment is being done.
- Name and area of expertise of the approved Medical Physicist (i.e. Diagnostic, Nuclear Medicine, Radiotherapy). For research proposals specific to Victoria, the medical physicist must be approved by the Department of Health and Human Services.
- Full title of the study with HREC number.
- An estimate of the total effective dose and organ doses* (where relevant) to be received by the volunteer as part of their enrolment in the proposed research. *Organ Doses only need to be quoted where there is a potential for a deterministic outcome.
- A statement as to whether the dose constraints are likely to be exceeded.
- An assessment of the risks associated with the estimate of the total effective dose.
- A recommended statement to be included in the Participant Information and Consent Form (PICF) related to the radiation dose being received, the associate risks, and the need for the volunteer to retain details of their radiation exposure.
The regulatory approval process
For Victorian sites
Research involving the use of Ionising radiation in addition to standard care may commence where:
- Dose constraints in the Medical Physics Radiation Dose and Risk Assessment have NOT been exceeded, AND:
- Site specific approvals has been issued by the HREC; and
- Recommendations contained within this medical physics risk assessment have been adopted.
- Dose constraints in the Medical Physics Radiation Dose and Risk Assessment HAVE BEEN exceeded, AND:
- Site specific approvals has been issued by the HREC;
- Recommendations contained within this medical physics risk assessment have been adopted; and The Department of Health and Human Services has been notified using the Notification where dose constraints will be exceeded form.
For research proposals conducted at Melbourne Health, the Radiation Safety Officer will notify Department of Health and Human Services of such research applications. You will be notified once this has occurred. For further information regarding this aspect please contact the Radiation Safety Officer.
For interstate sites
Please contact your local regulatory agency to determine if there are any special approval requirements.
NSW: Manager Hazardous Materials, Chemicals and Radiation, Environment Protection Authority
QLD: Radiation Health, Department of Health
WA: Secretary, Radiological Council
SA: Manager, Radiation Protection, Environment Protection Authority
Where the procedures in which exposure to ionising radiation are considered to be additional to standard care at some sites and standard care at other sites and/or the exposure dose is markedly different from site to site, the Coordinating Principal Investigator must investigate this difference with the respective site Principal Investigators and complete and submit the Ionising Radiation Variation Form part A. The Coordinating Principal Investigator must provide the reason for the variation and his/her opinion as to whether the differences are reasonable and acceptable.
Where the Research Protocol allows the Principal Investigator at each site to choose the modality of the investigations e.g.: CT scan or MRI; Echocardiogram or MUGA, CT scan or plain X-ray, the Coordinating Principal Investigator must complete the Ionising Radiation Variation form Part B for all sites where the ionising radiation modality is the chosen procedure and provide the rationale for this decision and his/her opinion as to whether this is reasonable and acceptable.