Abstract
This chapter describes the human research ethics guidelines that have been issued by national government agencies in Australia between 1966 and the present time. The identity, statutory or formal authority to issue such guidelines of each of these agencies is described as is the composition of the committees and approval bodies of each of the issuing agencies. The processes that these agencies were required to follow in the development and issues of guidelines are examined, as well as the more informal processes that they adopted in guideline development. These include requirements for public consultation and promulgation. Finally, the chapter concludes with some reflections on the strengths and weaknesses of those processes and on the effects of recent statutory changes to the key agencies.
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- 1.
Some published versions of this document added the word “Interim” to the title, in recognition of the need for further consultation and development.
- 2.
Universities Australia website, http://www.universititesaustralia.edu.au/content.asp?page=/about/index.htm. Accessed 3 Nov 2009.
- 3.
By the Health Legislation Amendment Act (No. 2) 2000, No. 6, Schedule 1.
- 4.
Australian Government 1990. Therapeutic Goods Regulations 1990, 12 AD.
- 5.
Nor have we have discussed our thoughts with Justice Robyn Layton QC who was the first chair of the Australian Health Ethics Committee.
References
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Competing Interests
The authors of the chapter have all had direct involvement in the development and issue of some of the guidelines and have drawn on their personal engagement as well as official records of this work.Footnote 5
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Thomson, C., Breen, K.J., Chalmers, D. (2016). Human Research Ethics Guidelines in Australia. In: Dodds, S., Ankeny, R. (eds) Big Picture Bioethics: Developing Democratic Policy in Contested Domains. The International Library of Ethics, Law and Technology, vol 16. Springer, Cham. https://doi.org/10.1007/978-3-319-32240-7_9
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