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94 S C O P E O F C R I T I C A L C A R E

oversee the implementation of the IPPs, including in edu- without consent only if the Chief Executive of the
cation and compliance issues. state health department considers it in the public
interest.
The Commonwealth Privacy Act 1988 sets out (in
Section 14) 11 IPPs that govern the conduct of Australian ● South Australia: In SA, a Cabinet instruction, based on
Commonwealth agencies in their collection, manage- federal IPPs, governs use and disclosure. That instruc-
89
ment and use of data containing personal information. tion does not permit relaxation of those standards,
The IPPs describe that agencies are not permitted to use although the Privacy Committee may exempt the hos-
or disclose, in identifiable form, records of personal pital, on conditions, from the requirements. There is
information for research and statistical purposes, unless also the Department of Health Code of Fair Information
specifically authorised or required by another law, or Practice 2004.
unless the individual has consented to their use or dis- ● Western Australia: The proposal for use and disclosure
closure (Privacy Act 1988). To avoid breaches of the above of personal information is reviewed by the Confiden-
privacy legislation where access to health information tiality of Health Information Committee.
may be required for research purposes, the NHMRC ● New South Wales: Both the Privacy and Personal Infor-
issued Guidelines under Section 95 of the Privacy Act 1988 mation Protection Act 1998 (NSW) and the Health
(s95 Guidelines). These were developed to provide a Records and Information Privacy Act 2002 (NSW) apply.
framework for the conduct of medical research where Directions under the former Act permitted relaxation
identifiable information held by any Commonwealth of its limits on disclosure. The latter Act permits dis-
agency (e.g. a public hospital) needs to be used without closure if the information is reasonably necessary for
consent, i.e. ‘if the public interest in the promotion of the research, if either the purpose cannot be achieved with
research is of a kind that outweighs “to a substantial non-identifying information or steps are taken to
degree” the public interest in maintaining adherence to de-identify the information, if results are not pub-
the IPPs’. 90 lished in a form that identifies individuals and if there
is an HREC review that favourably determines the
These were followed by the Guidelines approved under balance of public interests.
Section 95A of the Privacy Act 1988 (s95A Guidelines) to
provide a similar framework (to the s95); broadened to If the research is conducted at a national level and health
90
encompass the private sector. These include ten national information is needed from public and private hospitals
privacy principles (NPPs) that set the minimum stan- in all states and territories, all of these differences would
dards for the private sector. apply to the same project. These complexities present
significant challenges to researchers in both interpreta-
In addition, each state and territory has additional juris- tion and research conduct logistics. 92
dictional regulatory guidelines that apply to privacy and
use and disclosure of health information. The Northern In 2006, the Australian Health Ministers Advisory Council
Territory and Australian Capital Territory adhere only to (AHMAC) requested the NHMRC facilitate the develop-
the Commonwealth Privacy Act 1988. A summary of these ment and implementation of a national system where the
complex arrangements for the states, however, regarding single ethical review of a Human Research Ethics Com-
disclosure of personal health information, adapted from mittee (HREC) would be recognised by all institutions
91
Thomson, is as follows. participating in a collaborative research project. By having
a single ethical review outcome accepted by collaborating
For access to state hospital health information that is held institutions, protection of human participants would be
by state hospitals within Australia the Commonwealth maintained while delays due to the practice of seeking
Privacy Act does not apply and state regulation does multiple ethical reviews would be mitigated and time-
apply: whether specific legislation (New South Wales and lines for research start-up and results would be
Victoria) or regulatory instruments (Queensland) or shortened.
administrative directions (South Australia and Tasmania)
or administrative practices (Western Australia). Several states have developed formal systems for stream-
lining ethical review processes in public health organisa-
● Victoria: The Health Records Act 2001 (Vic.) and the tions. Other jurisdictions have informal arrangements
Information Privacy Act 2000 (Vic.) permit disclosure operating as agreements of acceptance between institu-
if it is reasonably necessary for research in the tions in the private and the public sectors and between
public interest; if it is impracticable to seek consent; public health organisations and universities.
if the agency believes that the recipient will not dis-
close the information; that the publication does not AHMAC’s direction that State and Territory systems
identify individuals and there is a favourable HREC should be ‘harmonised’ recognised that jurisdictional
review. statutory and administrative frameworks impacting
● Queensland: In a Queensland hospital, Information research in public health organisations differ.
Standard 42A imposes the same criteria as the The benefits of adopting a national approach to single
federal NPPs. It must be impracticable to seek consent ethical review are many, for example:
and an HREC must complete a favourable review,
using the guidelines under Information Standard ● The amount of time from ethical review application
42A. However, section 63F of the Health Services to research start-up is shortened, resulting in savings
Act 1991 (Qld) permits disclosure of information in human and monetary resources.