RPS 8 — Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005)

Table of Contents

1. Source documents

  • Official PDF retained locally — 2005 electronic edition with Annex 4 removed January 2015; retrieved 16 September 2026.
  • Extracted text
  • Provenance and SHA-256 metadata

2. Authority and jurisdiction

  • National code issued by ARPANSA for human research involving additional ionising-radiation exposure.
  • In Queensland it is a standard possession/use licence condition for health-related research on persons involving an ionising radiation source (Act s 75(3); Regulation s 70(1), item 5).
  • Operates with human-research ethics requirements; it is not a substitute for HREC review or local research governance.

3. Key takeaways

  • Applies to radiation exposure additional to normal clinical management that is undertaken for research purposes.
  • Requires a medical physicist to assess or independently verify participant doses and associated radiation risk.
  • The Human Research Ethics Committee (HREC) uses that assessment when judging justification, consent information and whether additional advice is needed.
  • Dose constraints are prospective research controls, not occupational/public dose limits and not therapeutic prescription limits.
  • The code states that its tabulated research dose constraints apply to diagnostic investigations, not radiation therapy.

4. Summary

4.1. 1 — Introduction and scope

  • Defines research exposure, application and the relationship between radiation protection and ethical review.

4.2. 2 — Responsibilities

Researcher
Describes the exposure, alternatives, participant group and expected benefit and supplies information needed for dose/risk assessment and consent.
Medical physicist
Assesses or independently verifies dose and explains radiation risk in a form suitable for ethics review and participants.
HREC
Reviews justification, risk, consent and compliance with applicable dose constraints; seeks additional expert advice where necessary.
Responsible Person
Establishes systems for implementation and compliance with radiation regulatory requirements at the facility.

4.3. 3 — Radiation dose constraints for participants

  • Requires doses to be kept to the minimum practicable and assessed or independently verified by a medical physicist.
  • Adult effective-dose constraints are 5 mSv in any year and 10 mSv over 5 years; the code provides different source-scoped values for limited-life-expectancy groups, older adults, skin and other tissues.
  • For children and fetuses, the table provides lower constraints, including 0.1 mSv from conception to birth and 0.5 mSv in any year from birth to age 18, within a 5 mSv total effective-dose constraint to age 18.
  • Exceeding a constraint does not automatically authorise or prohibit research; it triggers particular HREC scrutiny and potentially further independent authoritative advice.

4.4. Annexes

  • Provide methods for radiation-risk assessment, risk communication and implementation guidance.
  • Annex 4 was removed from the electronic edition in January 2015; do not rely on it for current occupational or public limits.

5. Important definitions, roles, limits and records

Additional research exposure
Exposure beyond that required for the participant's normal clinical management.
Dose constraint
A maximum with which normal research circumstances should be able to comply; it is an optimisation and ethics-review tool.
HREC
Reviews ethical acceptability; it does not replace radiation regulatory approval.
Records
Protocol, dose calculation/verification, physicist risk assessment, HREC decision, consent material, approvals and actual doses where required.

6. Practical relationship to the THHS RSPP

  • Supports the RSPP requirement for ROMP assessment of additional research exposure before approval.
  • Connects radiation governance to research governance, HREC review and participant risk communication.
  • Does not set radiotherapy treatment prescription limits; its dose-constraint table is explicitly for diagnostic research exposure.

7. See Also