Clinical and research consent for genomic testing

Patients who undergo genomic testing are legally required to provide ‘informed consent’. During this process, it is essential for patients to be provided with clear and transparent information to support their decision-making.

This project provides practice-informed genomic testing consent materials to support people to make informed decisions about genomic testing and the use of genomic and clinical data for research.

Following a two-year systematic review, consultation and piloting process, Australian Genomics in 2019 released a Clinical Consent Form for Genomic Testing together with a genomic testing factsheet to guide consent conversations. These materials have been adapted by many Australian genetics services to enable a standardised approach to patient consent. In the five years since its release there have been changes to clinical practice and national standards, meaning the consent package required updating.

Beginning in 2021, the Clinical and Research Consent for Genomic Testing Project is built on the two consent packages currently in use in Australia to ensure consent materials align with the latest developments in national and international guidelines.

The new materials, found below, incorporate evolving topics relevant to patient consent including re-contacting patients, genomic data reanalysis, data sharing and consent for future research. Materials include a genomic testing consent form, genetic testing consent form, patient fact sheet and health professional guide.

The project also aims to develop resources specifically designed to support Aboriginal and Torres Strait Islander people through the consent process, along with customised consent forms for somatic testing for non-inherited genetic conditions and prenatal genomic testing.