2. Clinical Trials in Australia
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Introduction
Each country and jurisdiction has the right to develop specific guidelines and legislation
to guide clinical research. Australian authorities have developed a range of laws and
guidelines relevant to clinical research. We will discuss these in brief but recommend
you familiarise yourself with these documents.
Transition
Guidelines and Legislation
Click on the boxes to find out about the different rules in Australia.
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Medical Research Endowment Fund
In Australia the regulation of human research began with the Medical
Research Endowment Fund Act in 1937.
The Commonwealth
Parliament had established the Medical Research Endowment Fund.
Responsibility for the Fund was vested in the Minister for Health who
could determine its use for medical research and in the training of
persons in medical research, acting on the advice of the National Health
and Medical Research Council, which was constituted in 1936.
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Statement on Human Experimentation
In 1966 the Council issued the Statement on Human Experimentation
that expressly drew on the Declaration of Helsinki. It outlined the ethical
principles that guide the conduct of human experimentation, in particular
how the rights of human subjects are to be protected. In 1972 a review
committee was convened to revise the Statement. Their report and
recommendations were handed down in 1976 and included a
supplementary note to the original Statement explicitly requiring
institutional ethical review of research be obtained. It was amended to
explicitly state coverage of all human research - medical, social and
behavioural.
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Therapeutic Goods Act and Registration
In 1989 the Australian government passed the Therapeutic Goods Act
which sets out the legal requirements for the import, export, manufacture
and supply of therapeutic goods.
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Governance
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So how are clinical trials governed in Australia? There are three tiers of
clinical trials governance. The Australian legislation underpinning the
legal governance of clinical trials is contained in two main documents the Therapeutic Goods Act 1989 and its associated documents – which
set out the legal requirements for the import, export, manufacture and
supply of therapeutic goods in Australia, and the inclusion of therapeutic
goods in the Australian Register of Therapeutic Goods, including
advertising, labelling, product appearance and appeal guidelines, Access
to Unapproved Therapeutic Goods in Australia 2004 which sets out the
regulations for allowing patients access to unapproved medicines or
medical devices by participation in a clinical trial. It is primarily
directed at sponsors and investigators, but will also provide useful
guidance to Human Research Ethics Committees.
There are also three guideline documents which researchers in Australia
are required to follow. The first is the International Guidelines, the ICHGCP annotated with comments from the Therapeutics Goods
Administration; the NHMRC National Statement on Ethical Conduct of
Research in 2007, which in Australia supersedes the ICH-GCP section
on ethics; the Australian Code for Responsible Conduct of Research
2007. It is worth noting that even though these documents were
specifically written for drug or medical intervention trials, it is generally
accepted that the principles apply to any research involving human
subjects.
[audio cuts out] the legislation and the guidelines, each organisation
which engages in human research will have their own organisational
policies; for example, they may have standard operating procedures
regarding disciplines for specific clinic trials and study protocols
specifically written for each trial or research study.
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National Statement on Ethical Conduct of Research
The 1999 National Statement addressed many issues not discussed in the
previous version, or issues discussed in less detail. It was a response to
the request for clearer guidance for those conducting research and those
involved in its ethical review without compromising the protection of
participants. The revised National Statement provided greater flexibility
in the practice of ethical review depending on the type and area of
research and the degree of risk involved.
Research often involves public interaction between people that serves a
public good. There is, therefore, a public responsibility for seeing that
these interactions are ethically acceptable to the Australian community.
That responsibility is acknowledged and given effect in the widereaching authority of this National Statement which sets out national
standards for the ethical design and review of conduct in human
research. Its content reflects the outcome of wide consultation with
Australian communities who participate in design, conduct, fund,
manage and publish human research.
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Australian Clinical Trials Handbook
In 2006 the TGA released the Australian Clinical Trials Handbook
intended to be a simple, practical guide to conducting clinical trials to
international good clinical practice standards in the Australian context.
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Access to Unapproved Therapeutic Goods
In 2004 the Therapeutic Goods Administration released the document,
Access to Unapproved Therapeutic Goods and Clinical Trials, in
Australia which are the regulations allowing patients access to
unapproved medicines or medical devices via participation in a clinical
trial. The changes reflected amendments to the Therapeutic Goods Act,
particularly the inclusion of medical devices. The Clinical Trial
Notification, or CTN, scheme and the Clinical Trial Exemption scheme,
or CTX scheme, continued to operate governing access to therapeutic
drugs and devices not yet included on the Australian Register of
Therapeutic Goods.
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Australian Code of Responsible Research
The Australian Code for the Responsible Conduct of Research was
developed jointly by the National Health and Medical Research Council,
the Australian Research Council and Universities Australia in 2007. The
Code has broad relevance across all research disciplines. It replaces the
National Health and Medical Research Council and Australian ViceChancellors Committee statement and guidelines on research practice
developed in 1997. The two main parts of this Code detail the principles
and practices encouraging responsible conduct of research, as well as a
framework for resolving allegations of misconduct in research. It is a
Code governing the practice of research for individual researchers as
well as institutions involved in research.
Resources
 http://www.tga.gov.au/industry/basics-regulation.htm
 http://www.nhmrc.gov.au/guidelines/publicatons/r39
 http://www.nhmrc.gov.au/health-ethics/human-research-ethics-committeeshrecs/human-research-ethics-committees-hrecs/nations
 http://www.tga.gov.au/industry/clinical-trials.htm
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