The Health Research Council's Gene Technology Advisory Committee (GTAC) undertakes scientific assessment of clinical trials that involve the introduction of nucleic acids, genetically manipulated micro-organisms, or viruses or cells into human subjects. It also makes recommendations to the Director-General of Health on whether or not trials should be approved.
- Professor Ian Morison, University of Otago, Dunedin - Chair
- Professor Ian Alexander, Sydney Children’s Hospitals, Sydney
- Associate Professor Lynley Anderson, University of Otago, Dunedin
- Professor Peter Browett, The University of Auckland
- Professor Stephen Chambers, School of Medicine & Health Sciences, University of Otago, Christchurch
- Dr Jade Hollis-Moffatt, University of Otago, Dunedin
- Professor Stephen Robertson, University of Otago, Dunedin
- Associate Professor Richard Robson, Christchurch Clinical Studies Trust, Christchurch
Process for Gene Technology Advisory Committee (GTAC)
Clinical trials that involve use of an unregistered medicine, for which the Minister has not given consent for distribution, require approval under Section 30 of the Medicines Act 1981.
Applications for GTAC approval are to be made by letter following the Guidelines for preparation of applications for GTAC review (section B of the Process and guidelines for applications for approval of trials involving gene and other biotechnology therapies).
The investigator seeking approval under Section 30 of the Medicines Act will also be required to lodge a fee, which in the case of public good research may be waived by the Ministry of Health on the recommendation of the HRC’s chief executive (for further information on the timeframe of review and fees, refer to Guideline on the regulation of therapeutic products in New Zealand part 11, www.medsafe.govt.nz).