Hereditary Cancer Services: Consent

Informed consent for testing is a legal requirement for genomic testing as the test results can have a life-changing impact not only for those being testing but also their families. 

Prior to testing, Informed Genomics Limited (IGL), trading as Nonacus Clinical Services, will require referring healthcare providers to confirm the informed consent has been obtained. This is done at patient registration on the Clinical portal. The specific requirements for consent and what should be discussed is based on the test being performed, but may include but not limited to discussion about potential outcomes, data and DNA storage and family implications. This ensures that those undergoing testing have been provided essential and appropriate information they need to make an informed choice as to whether the test is right for them.  

The consenting process is the responsibility of the healthcare provider. Any documentation pertaining to consent is stored by the healthcare provider. 

 

Delivery of pre-test counselling can be delivered either:

  • Directly by the health centre through adequately trained personnel 

or 

  • By GCRAB registered Genetic Counsellors

 

Verbal, written or electronic consent will be taken following delivery of pre-test counselling.

Nonacus Clinical Services required consent:

For testing of genetic material

It is important that the individual undergoing testing understands how the test works, its limitations, and what the impact of the results might beThey should also understand how long your DNA, genetic information, and personal data will be stored and how they may be used. Testing cannot go ahead unless you give your consent. 

For storage of DNA/RNA etc.

After testing, it is standard practice to keep materials such as DNA for a period of time. This may be done by the testing laboratory or the sample may be returned to the referring site for local storage. Stored material may be needed for future testing or for studies involving family members. Any stored material will only be used for the test agreed to, and for limited additional purposes as explained below.

For stored DNA to be used for family studies (Hereditary services)

As testing can impact family members, consent to use DNA as a control in future family studies is sought.

This is optional and does not impact on testing taking place.

For stored DNA to be used anonymously for internal quality control/service improvements

Consenting to testing includes storage of material which may at times be used by Nonacus Clinical Services for a limited number of internal processes. This includes ongoing internal quality improvements, monitoring of test performance and service improvements, only for the test indicated at time of consent. DNA is not used for research or supplied to third parties.

For personal and genomic data to be stored

The testing process generates genomic data which will be stored by the laboratory for a minimum period. All data will be kept securely by the laboratory and will not be transferred to any third party without permission.

Further information regarding the above can be found in the Nonacus Clinical Services Information for Service Users Handbook which is available upon request.