Overview of IBC
Overview of Institutional Biosafety Committee
National legislative framework
The Commonwealth has established a national legislative framework for the regulation of gene technology in Australia. This regulatory system is managed by the Office of the Gene Technology Regulator (OGTR). The Gene Technology Act 2000 was passed by Federal Parliament in December 2000 and takes effect from 21 June 2001. The Commonwealth Gene Technology Regulations 2001 form another component of the national scheme, also taking effect from 21 June 2001. More detail about the Regulator and the Regulations, including Application Forms, is available on the OGTR website.
A new regulatory scheme dealing with Security Sensitive Biological Agents (SSBAs) has been introduced and the Biosafety Committee needs to approve dealings with SSBAs as from January 2010.
The IBC's primary objective is to safeguard protection of personnel, the general public, and the environment. To meet this goal, the IBC imposes requirements for safe laboratory and biological safety practices; reviews and approves policies, procedures, training, programs and facilities pursuant to the safe use of biological agents, other biological materials, and toxins.
The IBC is responsible for reviewing and approving those research and teaching activities conducted by researchers, staff, students, and/or visiting scientists on SAHMRI property, and/or under the control of SAHMRI, staff or students, that involve the use of biohazardous materials including regulated animal and plant pathogens, biological toxins, and recombinant DNA molecules.
Responsibilities of the IBC:
- Assess the facilities, procedures, practices, and training and expertise of personnel involved with biohazardous research
- Lower the containment levels for certain experiments in which DNA from Risk Group 2, 3, or 4 or Restricted Agents is cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems.
- Perform periodic reviews and/or require modifications of recombinant DNA and/or biohazardous research and research facilities at SAHMRI to ensure compliance with the relevant guidelines and government regulations.
- Notify the Principal Investigator of the results of the IBC's review and approval
- Adopt emergency plans covering accidental spills and personnel contamination resulting from recombinant DNA research
- Report significant problems with or violations of the guidelines and any significant research related accidents or illnesses to the appropriate institutional official and when necessary to OGTR
- Suspend or terminate approval of research that is not being conducted in accordance with the IBC's requirements.
What is a Genetically Modified Organism (GMO)?
Gene technology is any work involving the modification of organisms by the direct incorporation (or deletion) of one or more genes to introduce or alter specific characteristic(s). Organisms created using gene technology techniques are known as GMOs .
Who regulates research conducted with GMOs?
A national regulatory scheme was introduced in Australia in 2001 to monitor all work involving GMOs. This regulatory system is administered by the Office of the Gene Technology Regulator (OGTR).
Organisations dealing with GMOs must be accredited and must have an Institutional Biosafety Committee (IBC), or access to an IBC, which reviews research applications and monitors certified facilities.
How to obtain approval to conduct research with GMOs?
To gain approval to work with GMOs you will first need to establish the level of dealing. Dealings are divided into three main categories based on the level of risk to researchers, the community and the environment.
Exempt dealings are considered to pose the lowest level of risk.
Notifiable Low Risk Dealings (NLRDs) are considered to be of intermediate level of risk and require that the work in conducted in facilities that have meet all the required certification guidelines.
Licenced Dealings are considered to have the highest level of risk and require approval from both the IBC, and the Office of the Gene Technology Regulator. These types of dealing are subdivided into Dealings involving Intentional Release (DIR) and Dealings Not involving Intentional Release (DNIR).
The OGTR have introduced new regulations and guidelines for working with GMOs and further information about it can be found on OGTR website (http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/gtr-review).
As a result of the amended regulations, many dealings have been downgraded. For example work conducted with either transgenic or knock out animals is now classified at a Notifiable Low Risk Dealing PC1 (PC1 NLRD) and can be conducted in a Physical Containment level 1 laboratory. Some dealings previously classified as NLRD have been changed to Exempt Dealings.
In order to conduct dealings with GMOs, researchers must submit the relevant application to the IBC for review.