Providing patients with clear information during the consent process for genomic testing is essential to support well-informed decisions about testing.
Genomic testing raises complex issues, with a number of possible testing outcomes and potential impacts for the individual and their family. However genetic testing services across Australia currently take independent approaches to clinical genomics consent.
This can affect the flow of health information across services and can confuse the interpretation of laws and policies about sharing genomic data for clinical or research purposes.
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 materials. 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 are being piloted in Victoria and Queensland.
The National Consent Working Group is also working closely with the NSW Ministry of Health as leads of national consent activity under the Australian Government’s National Health Genomics Policy Framework. Our state and national collaborations ensure harmonisation of activity and outcomes.
The consent form and supporting information will be evaluated to look at:
- the adequacy and completeness of the information included in the materials,
- the simplicity and clarity of the language used
- the degree to which the materials support the consent process for health professionals in the genomics community.
It is our vision that the consent form and supporting information will undergo ongoing assessment and refinement to retain currency and reflect regulatory evolution as genomics is mainstreamed throughout the Australian healthcare system.