Ethics Governance
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| Article - Abstract. To view full article click on the article title. | |
eMJA: Oversight and monitoring of clinical research with gene therapy in Australia The cornerstone of clinical research involving humans in Australia is the HREC (Human Research Ethics Committee). All studies must be approved by an HREC at the investigators’ institute(s). The demands on these committees are considerable, particularly when cutting-edge technology is involved. This was the situation in 1994 when the National Health and Medical Research Council (NHMRC) formed GTRAP (Gene and related Therapies Research Advisory Panel). The function of GTRAP was to provide the NHMRC, researchers, clinicians and HRECs with advice on medical, scientific and technical issues related to gene therapy,1 a novel form of treatment that had just been introduced in the United States. Its use in Australia — to treat severe combined immunodeficiency (SCID) — is described in this issue of the Journal (page 458).2 The NHMRC, through its Australian Health Ethics Committee, required that HRECs not give final approval for a gene therapy trial unless that trial had also been reviewed and approved by GTRAP. In Australia, gene therapy requires both local HREC and national GTRAP oversight. The reason for this was the novelty of the treatment, which does not involve traditional drugs or chemicals, but cells that have been genetically modified. Full Article: http://www.mja.com.au/public/issues/182_09_020505/tre10196_fm.html |
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2006 Ethics-Governance.com |
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