Surveillance and Research
Laboratories performing confirmatory testing must notify the relevant state and territory health authorities of any new positive laboratory diagnosis in accordance with the relevant legislation and regulations.
Where information is available to identify and monitor rates of newly acquired HIV infection, this information should be reported to the local state or territory health authority as appropriate. Laboratory evidence of acute or recent HIV infection is useful to monitor rates of incident HIV infection and to evaluate interventions.
Delinked blood surveys
Delinked anonymous surveys are studies in which specimens taken for other purposes (e.g. the neonatal heel prick specimen survey in 1989–90) are tested for HIV infection without consent after they have been coded, so that the results cannot be linked back to the individual who originally provided the specimen. The survey method should be considered for Australian surveillance purposes only where there is no other feasible method for reasonably obtaining appropriate data. Surveys must be subject to scientific justification and be endorsed by an institutional ethics committee (IEC) in accordance with the requirements prescribed by the NHMRC.
Identity unlinked HIV testing
Research using identity unlinked HIV testing can provide useful epidemiological data. In such studies, specimens used must be endorsed by an appropriate IEC in accordance with requirements prescribed by the NHMRC. For more information, see section HIV testing in the context of research (located in chapter: Indications for HIV Testing).
Data linkage projects
An increasing amount of clinical data is becoming available as a result of the development of electronic data storage. Linkage projects tied to HIV notification data can provide timely and relevant feedback on practice. Linkage to data including Medicare data, cancer registries, enhanced notification data and treatment and testing data must be endorsed by an appropriate IEC in accordance with requirements prescribed by the NHMRC. For example, in NSW, the NSW Public Health Act 2010 allows, and provides a framework for, the linkage of HIV notification data to data from some NSW Health administrative datasets including hospital admission data, death register data and emergency department data.
Use of stored blood for research on diagnostic technologies
Retrospective analysis of stored samples, particularly for the testing of new diagnostic technology or testing epidemiological hypotheses, must be conducted only on delinked or de-identified samples or be subject to appropriate ethical review and be endorsed by an IEC in accordance with the NHMRC.
Use of unregistered in-vitro diagnostic medical devices (IVDs)
Before its availability in Australia, any new testing technology or sample collection device must be approved by the TGA. However, IVDs not currently approved by the TGA (such as dried blood spot kits and tests which use alternative sample types) may be required to be used in research.
The TGA can provide access to an unapproved device through various exemption provisions. Access to an unapproved device for use in research can be sought through a clinical trial exemption.
Acknowledgement of Country