The benefits and risks of using genomic testing in clinical practice are being addressed in a national approach to the sensitive area of patient consent.
A review and consultation by research network Australian Genomics has led to a National Clinical Genomic Consent Form that will help to standardise practices around patient consent across the country.
It comes ahead of a multi-pronged approach by the states and territories to finalise nationally-consistent materials and templates for genetic and genomic testing under the auspices of the Australian Health Ministers’ Advisory Council.
The Australian Genomics consent form and accompanying materials were piloted in Victoria and Queensland from January to June this year. These are available and able to be adapted at a local level.
Consent is a crucial early stage in the genetic and genomic testing process as this is when the patient learns about the implications of proceeding with a test.
But in Australia it is left to the individual states and territories and the various genetic service providers to administer patient consent, potentially creating inconsistent experiences, outcomes and patient management.
“This is such a critical, if not the most critical, stage of the genomic testing journey these patients will embark on,” said project lead, Professor Julie McGaughran of Genetic Health Queensland.
“We need to ensure that patients are fully informed and comfortable about the possible outcomes of testing before we proceed.
“If we can establish trust and understanding between a practitioner and their patient at this early stage it will make future discussions and procedures easier”
The concise, two-page clinical consent form is accompanied by supporting material that explains the complexities around genomic testing.
- The testing process and different types of testing
- Potential outcomes from the results
- The implications of results for the patient and their family
- Data storage
- Options for sharing test data for research
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 annual review.