National Clinical Consent

A National Approach to Clinical Consent for Genetic and Genomic Testing

Providing the public with clear, consistent information during the consent process is essential to support informed decisions about genomic testing.

However currently in Australia, there is no single, standardised approach to administering patient consent for genetic or genomic testing.

In response to this need, Australian Genomics embarked on a review and consultation across two years, which has led to a national clinical consent form that will help to standardise practices around patient consent across the country.

The Australian Genomics consent form is available below for adaptation and use by clinical genetic services and health professionals responsible for guiding patients through the consent process for whole exome, whole genome or panel testing. 

Please ensure you have appropriate approval at a local level if you decide to use these forms. Clinicians employed through NSW Health should continue to use consent forms specific to that state.

The consent form is accompanied by supporting material (a ‘consent package’), which explains the complexities around genomic testing. These include:

  • testing process and the different types of tests
  • potential outcomes from the result of testing
  • impact of results for the patient and their family
  • storage of genomic data
  • options for sharing genomic data for research

Background on the development of a national consent form for genomic testing

In 2017 Australian Genomics formed a National Clinical Consent Working Group to identify opportunities to standardise consent processes for genomic testing across the country.

The Working Group undertook a systematic review of existing consent forms, developing guidelines for the content of consent materials, and drafted a consent form and supporting information. Both targeted and broad public consultations were undertaken on these materials in 2018.

In 2019, the National Clinical Genomic Consent Form and Supporting Information materials were piloted in Victoria and Queensland.

The evaluation looked at the adequacy and completeness of the information included in the materials, the simplicity and clarity of the language used, and the degree to which the materials support the consent process for health professionals in the genomics community.

Because the field of clinical genomics is moving so fast, Australian Genomics envisages that the consent form and supporting material will be living documents, requiring regular review.

We gratefully acknowledge the expert members of the Australian Genomics National Clinical Genomic Consent working group, and all those who have contributed to the development of these materials.

National Health Genomics Policy Framework activity

Nationally consistent approaches to consent

In 2019, the Australian Health Ministers’ Advisory Council (AHMAC) launched a project led by the NSW Ministry of Health to ‘build on existing work to develop and promote nationally consistent templates and guidance for consent’, under Australia’s Health Genomics Policy Framework, administered by the Project Reference Group on Health Genomics (PRG).

The project has established an Expert Advisory Group to oversee project deliverables and ensure coordinated information exchange, consultation and communications with key stakeholders. We are collaborating with the NSW led project to share the outcomes of our work to date, so that the learnings of our consultation and pilot can inform this process.

For further information on this project, please contact Ms Vanessa Fitzgerald, Principal Project Officer, Specialty Services and Technology Evaluation Unit, NSW Ministry of Health on (02) 9391 9544 or vanessa.fitzgerald@health.nsw.gov.au

Contact us

If you have any questions about the Australian Genomics consent materials please contact us info@australiangenomics.org.au