| Summary: | • Trade in human tissue in Australia is prohibited by state law, and in ethical guidelines by the National Health and Medical Research Council: - National statement on ethical conduct in human research; - Organ and tissue donation by living donors: guidelines for ethical practice for health professionals. • However, trade in human tissue products is a common practice especially for: - reconstructive orthopaedic or plastic surgery; - novel human tissue products such as a replacement trachea created by using human mesenchymal stem cells; - biomedical research using cell lines, DNA and protein provided through biobanks. • Cost pressures on these have forced consideration of commercial models to sustain their operations. Both the existing and novel activities require a robust framework to enable commercial uses of human tissue products while maintaining community acceptability of such practices, but to date no such framework exists. • In this article, we propose a model ethical framework for ethical governance which identifies specific ethical issues such as: - privacy; - unique value of a person's tissue; - commodification of the body; - equity and benefit to the community; - perverse incentives; and - "attenuation" as a potentially useful concept to help deal with the broad range of subjective views relevant to whether it is acceptable to commercialise certain human tissue products.
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