Use of ionising radiation for research purposes
Any research that involves exposure of humans to ionising radiation must follow the requirements of the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) (ARPANSA Radiation Protection Series No. 8), which has been adopted by the New South Wales Radiation Control Act.
The Code of Practice sets out a number of responsibilities and processes in relation to research involving exposure to ionising radiation. In particular, it requires an independent radiation dose and risk assessment that must be included with the submission to the HREC. The HREC submission must also outline the reasons why it is necessary to expose research participants to radiation for the purpose of the research and the steps that will be taken to minimise radiation exposure.
A radiation dosimetry and risk assessment report can be requested by completing the Radiation Safety Request Form and submitting it to the Radiation & Laser Safety Officer at St Vincent’s Hospital. The form must be submitted with a copy of the study protocol, patient information statement and consent form attached.
The assessment report will state the radiation dose for the radiological procedures that are additional to the procedures undertaken for normal clinical management. The assessment report will state whether the radiation dose exceeds the dose constraints in the Code of Practice as well as the risks associated with the radiation exposure in accordance with the advice in the Code of Practice. The report will also outline the level of benefit required from the research to justify the radiation exposure and a statement relating to risk of exposure that must be included in the Participant Information Sheet and Consent Form, guidance on appropriate wording can be found under standard forms page.
Please note, either the radiation safety report, or a statement from Investigator/radiation safety officer stating that all radiation exposure falls within the sites standard of care must be submitted to the HREC and acknowledged/approved prior to commencement of the study at a site.
Regarding this requirement please refer to the following references:
• Refer to the Research Office submission checklist
• https://www.arpansa.gov.au/sites/g/files/net3086/f/legacy/pubs/rps/rps8.pdf - Clause 2.1.7
• Victorian Specific Module – section 4
• As well as other interstate individual hospital requirements (Flinders Medical Centre Radiation risk assessment report document, HealthSupport Queensland – Research study radiation dose and Risk Assessment document)
Radiation Safety Request Form (DOC 192.5KB)
Alessandra Malaroda, PhD
Theranostic and Nuclear Medicine Department|
Tel: +61 2 8382 1807
- St Vincent's Hospital Guideline for Use of Ionizing Radiation for Research Purposes (PDF 58.7KB)
- The Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) Australian Radiation Protection and Nuclear Safety Agency, Radiation Protection Series No. 8, (RPS8)