Complete section 3 if your project involves radiation and/or genetically modified organisms (GMOs).
3a. Radiation element: Research involving ionising radiation
Where radiation (including pre-MRI safety screening examinations) is not additional to standard care
If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care, an independent assessment report by the RMH Medical Physicist must be included in the ethics application.
If radiation exposure (including pre-MRI safety screening examinations) in a research project is not additional to standard clinical management/care at the site, the site Principal Investigator (PI) must provide a confirmation letter.
The letter should be based on the template available on the Department of Health Clinical Trials and Research website and must be included in the ethics application submitted to the reviewing HREC.
Where radiation (including pre-MRI safety screening examinations) is additional to standard care
If radiation exposure (including pre-MRI safety screening examinations) in a research project is additional to standard clinical management/care, an independent assessment report by a Medical Physicist must be included in the ethics application (one report for each applicable site).
Special consideration
Where the procedures in which exposure to ionising radiation are considered to be additional to standard care at some sites and standard care at other sites, and/or the exposure dose is markedly different from site to site, the Coordinating Principal Investigator must investigate this difference with the respective site PIs and complete and submit the Ionising Radiation Variation Form Part A.
The Coordinating Principal Investigator must provide the reason for the variation and his/her opinion as to whether the differences are reasonable and acceptable.
Where the Research Protocol allows the PI at each site to choose the modality of the investigations – for example, CT scan or MRI, echocardiogram or MUGA, CT scan or plain X-ray – the Coordinating Principal Investigator must complete the Ionising Radiation Variation Form Part B for all sites where the ionising radiation modality is the chosen procedure and provide the rationale for this decision and their opinion as to whether this is reasonable and acceptable.
3b. GMO element: Projects involving Genetically Modified Organisms
For investigator-initiated trials involving GMOs
1. Request an appointment with the Office for Research
Email research@mh.org.au to request an appointment to discuss the application.
2. Read guidance documents
Read the following documents:
3. Trial sponsor responsibilities
The trial sponsor must advise the site:
- That the IP is a GMO
- The category of GMO
- If it requires regulation by the OGTR
Where regulation is required, the trial sponsor must also:
- Apply to the OGTR for a licence or exemption documentation
- Confirm who is responsible for organising Institutional Biosafety Committee (IBC) review of the trial (sponsor or site)
- Provide the licence or exemption documentation to the site and the responsible IBC
- Provide information to the study site in a timely manner to allow site to conduct feasibility review, obtain departmental and service approvals, and submit applications for ethical and research governance approval
4. Site staff responsibilities
The study site staff should:
- Request confirmation from the sponsor on whether the IP is a GMO that requires regulation early in feasibility discussions
- Undertake a feasibility assessment for trials using a GMO as there may be extra costs and procedures involved
- Request the following information from the sponsor for inclusion in the application:
- Product information
- Classification of the GMO
- GMO Licence issued by the OGTR (if this has been issued)
- Questions and answers on licence decision (if licence issued)
- Summary of Risk Assessment and Risk Management Plan (if Licence has been issued)
- Full Risk Assessment and Risk Management Plan prepared by the OGTR (if licence issued)
- All GMO-specific information to be provided to the participant
- Name of the IBC that will review the GMO application
- IBC approval letter
- IBC review correspondence – queries and replies
- Confirmation the sponsor will provide GMO/study-specific training for the site
- Update SOPs/prepare additional site SOPS to cover trial GMO processes.
- Inform service departments that the study involves a GMO and any special conditions and/or procedures that will be involved in handling, transport, storing or disposal of the GMO.
5. Complete ethics application
Include as much of the above information in the ethics application as possible.
6. Ensure the IP is described as a GMO
Ensure that the HREA flags that the IP is a GMO.
Ensure that the protocol and information to participants describes the IP as a GMO and includes requirements identified as per:
- The Licence
- The Risk Assessment and Risk Management Plan
- Any other requirement
The RMH does not run an IBC. Access to IBC review managed by the RMH site is via the PMCC Clinical Trials IBC.
Requirements for projects involving GMOs
This information relates to clinical trials involving investigational products (IP) that are, or contains, a genetically modified organism (GMO).
In addition to the Therapeutic Goods Act (1989) and Regulations (1990), trials involving GMOs are subject to the Gene Technology Act 2000 and Gene Technology Regulations 2001, which are administered by the Gene Technology Regulator (the Regulator), supported by the Office of the Gene Technology Regulator (OGTR) and Victorian state legislation that aligns with the federal legislation.
- TGA – the human safety and efficacy of investigational products
- OGTR – the health and safety of people and the environment from risks posed by gene technology
The type of OGTR regulatory approval required depends on the nature of the GMO and on its likely fate once introduced into the trial participant, specifically whether the GMO is expected to be transmitted or shed by trial participants, thereby entering the environment.