Oversight and monitoring of clinical research with gene therapy in Australia

Ronald JA Trent PhD, FRACP, FRCPA
Med J Aust 2005; 182 (9): . || doi: 10.5694/j.1326-5377.2005.tb06781.x
Published online: 2 May 2005

The NHMRC has set up the Gene and related Therapies Research Advisory Panel (GTRAP) to oversee gene therapy research

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

  • Ronald JA Trent PhD, FRACP, FRCPA

  • Department of Molecular and Clinical Genetics, Central Clinical School of the University of Sydney, Royal Prince Alfred Hospital, Sydney, NSW.


Competing interests:

As Chair of GTRAP, Professor Trent is paid an allowance.


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