4a. Radiation element: Research involving ionising radiation
All RMH projects involving ionising radiation require written advice from the RMH Medical Physicist regardless of whether the procedures are additional to standard of care or not.
- Complete and submit Medical Physics Risk Assessment Interventional, Diagnostic & Nuclear Medicine Procedures Supporting Information.
- Provide a copy of the independent assessment report conducted by the RMH Medical Physicist.
This applies to all research projects undertaken at the RMH which involve radiation exposure, including pre-MRI safety screening examinations.
Submit all documents to
- email: RMH Medical Physicist and Radiation Safety Officer
- phone: (03) 9342 8378
Record both the local HREC Project Number EPIC EMR number on all documents.
Informing participants in research
Where required and directed by the Medical Physicist review, ensure that the exact radiation wording is included in the site specific participant information and consent form.
4b. GMO element: Projects involving Genetically Modified Organisms
- For Investigator initiated trials request an appointment with the Office for Research to discuss the application.
- Download and read the following documents:
- The trial sponsor must advise the site that:
- the investigational product is a GMO;
- the category of GMO; and
- 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
- 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
Refer to Guidance for conducting clinical trials involving GMOs at the RMH for details of information required and timeframes for submission
- 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 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 he study involves a GMO and any special conditions and/or procedures that will be involved in handling, transport, storing or disposal of the GMO.
- Include as much of the above information in the ethics application as possible
- 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 GMOs is expected to be transmitted or shed by trial participants, thereby entering the environment.
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