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