Research involving irradiation of people

Overview

The Radiation Act 2005 defines a radiation practice to include, among other things, the possession of a radiation source. It also includes the 'procuring or arranging research that involves the irradiation of persons'. Therefore, the procuring or arranging research that involves the irradiation of persons must be authorised by a management licence.

Code of practice - exposing people to radiation for research

The Code of practice for the exposure of humans to ionizing radiation for research purposes establishes responsibilities of the researcher, the medical physicist and the Human Research Ethics Committee (HREC) in relation to research at the relevant institution.

In particular, the code:

• requires that the researcher must obtain approval for the research from the HREC at the relevant institution that is independent of the teams of researchers and constituted in accordance with the National Statement on Ethical Conduct in Human Research. The committee itself will need to have access to independent authoritative advice in relation to the justification for the radiation exposure
• requires that the researcher must obtain an independent assessment or verification by a medical physicist of the total effective dose (whether or not the effective dose will exceed the constraints in Table 1 of the code) and the risks associated with the radiation exposure
• requires that the medical physicist must:
  • independently verify the total effective doses, the organ doses and the radiation risk assessment provided by the researcher, or
  • provide an assessment of both the expected total effective dose and organ doses likely to be received by the research participant as a result of their participation in the research and of the corresponding radiation risks, and
  • where the dose constraints in Table 1 of the code are exceeded, obtain verification of the dose assessment by a second medical physicist who must be independent of the researcher
• describes the responsibilities of the HREC and, in particular, that they should consider the balance between the likely benefits and risks associated with any radiation exposure
• requires that the radiation doses to research participants must be kept to the minimum level practicable, and assessed or independently verified by a medical physicist

The medical physicists do not necessarily have to be directly employed by the organisation, but the applicant must demonstrate that the necessary arrangements are in place to access medical physics expertise when required (see 'Approved medical physicists' for a list of those who can perform this role)

Wherever possible, the total effective doses and the organ doses to adults and to children should conform to the dose constraints in Table 1 of the code. If those dose constraints are to be exceeded, the HREC must give particular attention to the justification for the radiation exposure.

Research involving irradiation of people - variations to existing management licences

Most major public hospitals and universities hold a management licence that authorises both the procuring or arranging of research involving irradiation of persons and the possession of radiation sources for medical purposes.

When an organisation already holding a management licence authorising possession of radiation sources for medical purposes wishes to start procuring or arranging research projects, that organisation will need to apply to the department for a variation to their management licence.

Prerequisites: what information do I include with my application?

1. Applicants will need to demonstrate that they have the systems necessary to enable them to comply with the code. Organisations that do not hold a management licence will need to apply for a management licence.
2. A Radiation Management Plan for research involving irradiation of people

   A Radiation Management Plan (RMP) is now a mandatory prerequisite that must be submitted when undergoing any of the following activities:

• Applying for a new Radiation Management Licence
• Applying for a variation to an existing Radiation Management Licence
• Applying to transfer an existing Radiation Management Licence to another legal entity

The Radiation Management Plan page provides details on the minimum requirements that must be included in your RMP.

Conditions of licence and other relevant documents

Compliance with the following is a condition of management licences issued in relation to practices procuring or arranging research involving the irradiation of persons must be familiar with these requirements:

The licence holder must:

1. ensure that research involving the exposure of person to ionising radiation is carried out in accordance with the Code of Practice for the Exposure of Humans to Ionising Radiation for Research Purposes (2005)
2. where the proposed radiation doses to persons for any research project are proposed to exceed the dose constraints listed in Table 1 of this Code, ensure that:
   1. independent authoritative advice in relation to the justification for the radiation exposure is available to the Human Research Ethics Committee and
   2. using the Research Notification Form, the department is notified within 14 days of the research project receiving site authorisation at the institution.

The licence will also require reporting of radiation safety incidents. Licensed activities, such as the possession of a radiation source, will also include different conditions with which compliance is necessary.

Any licence that authorises the procuring or arranging of research involving the irradiation of persons will have a specific schedule (Schedule 8 on a management licence) relating to this research that outlines the conditions of licence pertaining to this research.

Note that management licences no longer specifically list research projects in this schedule.

Research involving irradiation of people - before the project starts

Typically, the lead researcher will initiate the approval process by applying to an HREC. These application forms include what is called the 'Victorian-specific module', which includes Section 4 - Use of ionising radiation, which is a form that specifically relates to the use of ionising radiation.

These forms and any accompanying information are then submitted to the appropriate HREC for their consideration.

Once the HREC has approved the project, the lead researcher, on behalf of the lead organisation, needs to follow the process described below.

The research project proposes radiation doses that are below the dose constraint described in Table 1 of the code

If the project proposes radiation doses that are below the dose constraints in Table 1 of the code, approval has been given by the HREC and any required site authorisation has been given, then the research project may start. The department does not need to be notified of the project.

The research project proposes to exceed the dose constraint described in Table 1 of the code

If the project proposes radiation doses that will exceed the dose constraints in Table 1 of the code, has been approved by the HREC and has obtained any required site authorisation, then the licence holder needs to notify the department of the specific project.

Multisite research projects

The coordinating principal investigator must complete the 'Victorian-specific module' and the principal investigator at each participating research site must complete the 'Section 4 -- Use of ionising radiation form'.

An assessment of the proposed radiation doses for all of the sites involved in the project must be submitted to the HREC to ensure that dose variations from site to site are properly assessed.