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Regulatory Framework * Trials Involving Gene Therapy

Clinical trials involving gene therapy or related therapies require approval from a Human Research Ethics Committee (HREC) and may also be reviewed by the new NHMRC committee - the Cellular Therapies Advisory Committee (CTAC). This committee is advisory only, since there is no requirement for gene therapy clinical trial proposals in Australia to be reviewed by the NHMRC. However, CTAC is available to provide advice to HRECs, the TGA or the OGTR, should they wish to seek it. Initial assessment of a trial protocol is performed by the HREC which will then pass the protocol to CTAC for further assessment to determine the safety of gene and related therapies before making a recommendation to the HREC.

Human gene therapy research proposals are normally submitted via the CTX Scheme unless the CTA and HREC have assessed that the research can be undertaken using the CTN scheme.

Sponsors wishing to conduct trials in Queensland using gene or related therapies can contact QCTN to be directed to the appropriate member(s) for assistance.

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