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IBC
        

Increasingly, leading-edge, first-in-man therapeutic research is being performed in Australia making use of the high-tech facilities and world class expertise. It was for this reason, that Australia’s first independent Institutional Bio-safety Committee (IBC) was established by QCTN to assist members and sponsors undertake early clinical research involving genetically-modified (GM) products.

Role of IBC

To review applications to administer Genetically Modified Organisms (GMOs) to human volunteers as part of authorised clinical trials in Australia (as exempted or notified under the Therapeutic Goods Act, 1989)

To support pharmaceutical/biotechnology companies with commercial distribution licence applications (DNIR or DIR) at the discretion of QCTN and IBC

If required, to arrange certification of facilities to specified physical containment levels

Procedure

Please contact the CEO of QCTN to discuss your requirements and to obtain information about an IBC review.

Background

On 21 June 2001, a new system for the regulation of gene technology and genetically modified organisms (GMOs) took effect in Australia. The legislation regulates 'dealings' involving GMOs (which includes clinical trials involving GMOs). Persons or organisations wishing to deal with GMOs need to apply to the Office of the Gene Technology Regulator (OGTR) through an accredited IBC, to obtain approval to undertake work with GMOs.

The QCTN IBC is constituted and functions as per the requirements of the Gene Technology Act 2000 (Cth) and the Gene Technology Regulations 2001 (Cth). Collaborating organisations must also refer to the 'Handbook on the Regulation of Gene Technology in Australia', published by the OGTR, to obtain information about the requirements of the legislative scheme. The IBC is responsible to the Queensland Clinical Trials Network Inc for ensuring that the requirements of the legislation are met. The IBC is also responsible for providing advice and assistance to collaborating organisations wishing to undertake work involving GMOs.

   
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