Radiation in Research
A Guideline for Barwon Health Researchers
The Radiation Protection Series No. 8 (RPS 8) Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes(ARPANSA, 2005) ensures researchers provide radiation exposure information that allows consent to be properly considered by research participants and Human Research Ethics Committees.
Section 2.1.7 of RPS 8 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."
Ionising Radiation Procedures
- Diagnostic imaging: e.g. CT scans (including CT guided biopsies), DEXA scans, x-rays, fluoroscopy (e.g. PICC line insertion under fluoroscopy guidance), OPG and Angiography
- Nuclear medicine: all scans, including Positron Emission Tomography (PET) and Gated blood pool scans (MUGA)
The Radiation Act (2005) in Victoria licenses sites individually to perform research. This arrangement, and because the amount of radiation varies from site to site, means multi-site research projects need to determine radiation exposure at each site independently, and provide radiation documents for each site. This information is then supplied to the central HREC review committee. Only ionising radiation exposure additional to standard of care is assessed by an approved medical physicist.
What is required to be submitted for HREC review at each site?
Standard of Care
It is the responsibility of the trial site Principal Investigator to determine if radiation required for the trial forms part of standard of care for participants. If you are unsure please seek advice from a Radiologist, Nuclear Medicine Physician, or Medical Physicist.
If the use of ionising radiation exposure is deemed standard of care, the site Principal Investigator completes a HREC Radiation Notification Letter. The letter must be provided to the Coordinating Principal Investigator for inclusion in the ethics application.
HREC Radiation Notification Letter
- Submit this letter to the HREC for review (signed by Prinicpal Investigator) via ERM (Ethical Review Manager)
Additional to Standard of Care
If radiation exposure is additional to that received as normal clinical management/care, an independant assessment report by a Medical Physicist is required for review by the HREC. One report is required for each sire where imaging is performed.
The report will include the effective dose, relevant organ doses, a risk assessment, and recommended text for the PICF. The report must be provided to the Coordinating Principal Investigator for inclusion in the ethics application. Individual site reports must also be provided in the relevant site governance submission.
RPS contains defined dose constraints which apply over a one year period (See RPS 8 Table 1).
If the dose of radiation is above the dose constraint (as defined in RPS 8), verification of doses by a second medical physicist report is required. The medical physicist usually arranges the verification by another physicist. If approval is given by the HREC, then REGI must notify the Radiation Team at Department of Health & Human Services (DHHS) within 14 days. If the project is approved, the project may commence prior to notification being submitted to DHHS.
If the dose of radiation is below the dose constraint of the ARPANSA Code and approval has been given by the HREC, no DHHS notification is required.
How to obtain a medical physicists report
Barwon Health Site
Submit a 'Victorian Medical Physicists Risk Assessment Form' to Barwon Health Medical Physicist, Dr Alex Merchant via email [email protected] or phone (03) 4215 0404. If Alex is unavailable, an external medical physics consultant can be engaged. For example, Paul Einsiedel can be contacts via [email protected] or phone 0419 304 867. Other physicists are listed on the DHHS website here.
Other Victorian Sites
Other Victorian sites may require this form, or may use the older Victorian Specific Module Section 4. Refer to Institutional Research Office websites for details of site requirements.
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; Email - [email protected]
QLD: Radiation Health, Department of Health; Email - [email protected]
WA: Secretary, Radiological Council; Email - [email protected]
SA: Manager, Radiation Protection, Environment Protection Authority; Email - [email protected]
Last Modified: Friday, 22 March 2019