Biosafety and gene technology
Please note: If your research or other activity involves humans, animals, chemical hazards or radiation safety you must also obtain ethics approval from the relevant committee
| Biosafety | Gene technology |
|---|---|
See the Australian Code for the Responsible Conduct of Research (PDF 508kb, download Adobe Acrobat)
Biosafety
Introduction
Biosafety covers the proper use of biologically hazardous material. Biological hazards include any biological or pathogenic agent, substance or material (living or non-living) that may pose a threat to the health and safety of the researcher, participants, community or environment, or needs special precautions to be taken in their use or storage.
- You are required to consider biosafety, health and safety issues related to your teaching or research and comply with the legislative and regulatory requirements.
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If your work involves pathogenic substances in Risk Group 3 or 4 (AS/nzs2243.3) (currently under review) you must apply for approval. Access AS/nzs2243.3 via the SAI Global online public library database (UniSA Library)
You must gain approval from the Institutional Biosafety Committee prior to commencing teaching or research involving the use of biological hazardous material.
Policies and guidelines
Refer to
University policy RES 4.3Application forms
Research involving the use of toxic biological substances must be approved by the Institutional Biosafety Committee
For teaching or research involving biological hazards involving pathogenic organisms of Risk Group 3 or 4 of the Australian Standards, please contact Professor Mary Barton (ext 22933 or email mary.barton@unisa.edu.au).
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Application for approval to use hazardous substances for research purposes -
Completed application forms must be submitted to:
| Internal postal address | External postal address |
|---|---|
|
Ms Alice Granger |
Ms Alice Granger |
Timelines
Once you submit your application, feedback (which might include the requirement that your application be considered by a full Institutional Biosafety Committee meeting) will take a maximum of 10 working days. Please contact Alice Granger ext 23523 or email alice.granger@unisa.edu.au if you have not had a response within this timeframe.
Permits
Imported biological products must have an Australian Quarantine and Inspection Service (AQIS) permit for importation and AQIS approval for transfer to another institution.
Gene technology
Introduction
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 Gene Technology Regulations of the Gene Technology Act 2000
Genetically modified organisms (GMOs) are organisms which have been modified by gene technology or organisms that have inherited traits that occurred in the initial organism because of gene technology. Therefore, even if you do not construct the GMO yourself, the act of propagation (ie growing the strain in the laboratory) falls within the definition.
You must gain approval from the Institutional Biosafety Committee prior to commencing teaching or research involving genetically modified organisms.
Policies and guidelines
Refer to University policy RES 4.3
The Federal Government has established the Office of the Gene Technology Regulator (OGTR). The website gives full information about genetically modified organisms and the regulations governing gene technology in Australia. The University of South Australia is an accredited organisation under the Act. OGTR guidelines must be adhered to.
Handbook on the Regulation of Gene Technology in Australia
(PDF file, 364kb)
Guidelines for the identification of an exempt dealing or of a notifiable
low risk dealing can be found in the OGTR handbook.
Application forms
Please refer to the application forms on the OGTR website which are filled out online, then printed for signing and submission. The University's Institutional Biosafety Committee assesses and reviews all proposals involving dealing with GMOs and, where required by the OGTR guidelines, submits them for assessment.
There are four types of dealings for GMOs. You will need to fill out the application form(s) relevant to the dealing your teaching or research is using.
1. Exempt dealing: These are dealings that pose negligible risk as assessed over time, are contained within a facility and will not be released into the environment. The use of an exempt dealing organism does not require a licence however researchers must notify the Institutional Biosafety Committee of projects using exempt dealing GMOs.
2. Notifiable low risk dealings: These are dealings that pose low risk (as assessed over time), must be contained within a certified facility with an accredited organisation, and (if transported) must be moved within OGTR guidelines for transport of GMOs.
- Record of Proposed Notifiable Low Risk Dealings (NLRD's) - required for all NLRD's assessed after 1 July 2007 - posted 1 July 2007 (OGTR website)
- Application for certification of a facility (OGTR website)
3. Dealings not involving release: These are ddealings that are neither exempt nor notifiable low risk dealing and do not involve release. They are GMAC Category A (large and small) projects. A license from the OGTR is required for their use prior to commencing the project.
- Application for licence for dealings with a GMO not involving intentional release of the GMO into the environment (DNIR) (OGTR website)
4. Dealings involving release: These are projects involving release of GMOs. A license from the OGTR is required for their use prior to commencing the project.
- Application for licence for dealings with a GMO involving intentional release of the GMO into the environment (DIR) (OGTR website)
For further information, please contact Professor Mary Barton (ext 22933 or email mary.barton@unisa.edu.au).
Completed application forms must be submitted to:
| Internal postal address | External postal address |
|---|---|
|
Ms Alice Granger |
Ms Alice Granger |
Timelines
Once you submit your application, feedback (which might include the requirement that your application be considered by a full Institutional Biosafety Committee meeting) will take a maximum of 10 working days. Please contact Alice Granger ext 23523 or email alice.granger@unisa.edu.au if you have not had a response within this timeframe.
Useful links
Essentially yours: the protection of human genetic information in Australia
(Australian Law Reform Commission Report 2003)
Ethical aspects of
human genetic testing: an information paper
(NHMRC 2000)
Guidelines for ethical review of research proposals for human somatic cell
gene therapy and related therapies
(NHMRC 1999)
Guidelines for genetic registers and associated genetic material
(NHMRC 1999)
Gene Technology Act 2000
Gene Technology Regulations 2002
National Health Security Act 2007
National Health Security Regulations 2008 (PDF file)
Related codes and guidelines
AS/NZS 2243.3:2002 - Safety in laboratories - Microbiological aspects and containment facilities. This is under review at the moment. Electronic copies can be accessed via the Library
Insurance cover for your project
Approval of your ethics protocol by Institutional Biosafety Committee normally means that you are covered by the University's insurance policies in relation to your research project.
However, you must complete the appropriate insurance form and submit it to the University's Insurance Officer if your research falls within one or more of the descriptions below:
- involves a 'professional service' for which UniSA staff or students have obtained qualifications
- poses a physical risk to researchers, students or participants (where injury appears possible or likely)
- involves treatment or testing on human/animal participants
- involves questionnaires/surveys/information gathering in relation to a psychological condition/trauma/illness or history of such, or collection of personal data
- is to be conducted in a hospital/clinic/consultancy/professional treatment area
- involves participation or sponsorship by a third party such as a hospital/clinic/consultancy/professional service provider/other researcher/University
- involves research in remote areas or outside of Australia
- involves Indigenous participants or Indigenous research.
The University's Insurance Officer will provide confirmation of insurance cover for your research project. To finalise ethics approval, you will then need to submit this confirmation to UniSA Institutional Biosafety Committee.