A/9.3 Biosafety/health and safety in research

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9.3.1 Biosafety/health and safety issues in research
9.3.2 Clearance process
9.3.3 Genetically modified organisms (GMOs)
9.3.4 Ethical clearance and biosafety/health and safety issues
Modification History

9.3.1 Biosafety/health and safety issues in research

Research can involve a range of biosafety and broader health and safety issues. These issues can represent a risk to the

• research subjects
• research team
• University community
• wider community, and the
• environment.

The University takes its role in relation to managing these risks extremely seriously. When planning a research project a researcher should consider what biosafety/health and safety issues relate to their proposed study.

Biosafety/health and safety issues in research include

• working with a human pathogen
• work where there is a risk of physical injury
• work with ionising radiation, and
• work with materials where there is a risk of contagion.

Researchers who are unsure whether their study involves any biosafety/health and safety considerations should consult with their faculty's Workplace Health and Safety Officer or the Chemical and Biosafety Advisor located within HR Health and Safety Advisory Services.

See section D/6 for information on ethics and experimentation in research.

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9.3.2 Clearance process

Faculties must establish a process for confirming that the biosafety/health and safety issues relating to research conducted by their researchers have been considered and appropriately addressed.

Given the diverse nature of research at QUT, there is no single prescribed model for the consideration of biosafety/health and safety issues. For example, some faculties may elect to establish a distinct biosafety committee, while others might elect to add this responsibility to the role of their existing health and safety committee.

Faculties can elect to delegate this responsibility to the School level, but must maintain appropriate monitoring/auditing mechanisms and records of same. Faculties may elect to seek additional advice on biosafety/health and safety issues from HR Health and Safety Advisory Services, or from an appropriate expert (internal or external).

Faculties must submit their clearance process for the clearance of biosafety/health and safety in research projects to the Deputy Vice-Chancellor (Research and Commercialisation) for approval. The Deputy Vice-Chancellor (Research and Commercialisation) may elect to randomly audit a faculty's process.

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9.3.3 Genetically modified organisms (GMOs)

The Gene Technology Act 2000 defines a genetically modified organism (GMO) to mean:

1. an organism that has been modified by gene technology; or
2. an organism that has inherited traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
3. anything declared by the Gene Technology Regulations to be a genetically modified organism, or that belongs to a class of things declared by the Regulations to be genetically modified organisms; but does not include:
4. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
5. an organism declared by the Regulations not to be a genetically modified organism, or that belongs to a class of organism declared by the Regulations not to be genetically modified organisms.

In order to understand the definition of GMO it is important that two further terms are understood - " organism " and " gene technology " .

" Organism " is defined in the Gene Technology Act to mean a biological entity that is viable, capable of reproduction or capable of transferring genetic material.

" Gene technology " is defined as any technique for the modification of genes or other genetic material, but does not include sexual reproduction, homologous recombination or any other techniques specified in the Regulations.

Biosafety issues relating to research involving GMOs are considered by QUT Institute Biosafety Committee (see section D/6.6 ). QUT Institute Biosafety Committee has been accredited by the Gene Technology Regulator to represent QUT and is responsible for ensuring that QUT has quality assurance systems in place to comply with the legislation. These systems include internal checking of applications, systems of record keeping and reporting, and procedures for training of staff dealing with GMOs. All projects involving GMOs must be submitted to this committee for clearance.

The membership of QUT Institute Biosafety Committee includes an adviser from within the School of Life Sciences. Researchers from outside the School of Life Sciences should make arrangements for a person with appropriate discipline and biosafety expertise to be available to advise QUT Institute Biosafety Committee if required.

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9.3.4 Ethical clearance and biosafety/health and safety issues

Where the project requires ethical clearance, final clearance will be subject to faculty biosafety/health and safety clearance, and/or QUT Institute Biosafety Committee clearance, if appropriate to the study. The relevant ethics committee need only be provided with a memorandum indicating that biosafety / health and safety clearance has been granted by the faculty. Such clearances can be sought in parallel, but the research cannot be commenced until both ethical clearance and biosafety / health and safety clearance have been obtained.

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Modification History

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