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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Notes
- 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
Australian Institute of Aboriginal and Torres Strait Islander Studies. 2000. Guidelines of ethical research in indigenous studies. Canberra: Australian Institute of Aboriginal and Torres Strait Islander Studies.
Australian Institute of Aboriginal and Torres Strait Islander Studies Act 1989 (Cwlth). Canberra: Commonwealth of Australia. http://www.comlaw.gov.au/Details/C2012C00085. Accessed 14 Jan 2015.
Australian Research Council Act 2001 (Cwlth). Canberra: Commonwealth of Australia. http://www.austlii.edu.au/au/legis/cth/consol_act/arca2001266/index.html. Accessed 14 Jan 2015.
Dodds, S., R. Albury, and C. Thomson. 1994. Ethical research and ethics committee review of social and behavioural research proposals, Report to the Department of Human Services and Health. Canberra: Commonwealth Department of Human Services and Health.
Health Legislation Amendment Act (No. 2). 2000. Canberra: Commonwealth of Australia.
National Health and Medical Research Act 1992 (Cwlth) (NHMRC Act 1992). Canberra: Commonwealth of Australia. http://www.comlaw.gov.au/Series/C2004A04516. Accessed 14 Jan 2015.
National Health and Medical Research Council Amendment Act, (Cwth) 2006. Canberra: Commonwealth of Australia. http://www.comlaw.gov.au/Series/C2004A04516. Accessed 14 Jan 2015.
National Health and Medical Research Council (NHMRC). 1966. Statement on human experimentation and supplementary notes. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 1983. Ethics in medical research. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 1987. Medical Research Ethics Committee Newsletter 1(1).
National Health and Medical Research Council (NHMRC). 1988. Some advisory notes on ethical matters in Aborignal Research including a report of the National Workshop of Research in Aboriginal Health. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 1991. Guidelines on ethical matters in Aboriginal and Torres Strait Islander Health Research. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 1996a. Ethical guidelines on assisted reproductive technology. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 1996b. Report of the review of the functioning of institutional ethics committees. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 1999. National statement on ethical conduct in research involving humans. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 2003. Values and ethics: ethical guidelines for the conduct of Aborignal and Torres Strait Islander health research. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 2004. Ethical guidelines on the use of assisted reproductive technology in clinical practice and research. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 2005. Keeping research on track: A guide for Aboriginal and Torres Strait Islander peoples about health research ethics. Canberra: Commonwealth of Australia.
National Health and Medical Research Council (NHMRC). 2007a. National statement on ethical conduct in human research. Canberra: Commonwealth of Australia.
National Health and Medical Research Council, Australian Research Council, and Universities Australia. 2007b. Australian code for the responsible conduct of research. Canberra: Commonwealth of Australia.
Therapeutic Goods Administration. 2000. Note for guidance on good clinical practice (CPMP/ICH/135/95). Canberra: Commonwealth of Australia.
Therapeutic Goods Regulations 1990 (Cwlth). Canberra. Commonwealth of Australia. http://www.comlaw.gov.au/Series/F1996B00406. Accessed 14 Jan 2015.
Tobacco Institute of Australia Ltd & Ors v National Health & Medical Research Council & Ors. 1996. FCA 1150.
World Medical Association. 1964. Declaration of Helsinki: Ethical principles for research involving human subjects.
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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