What is it?
Informed consent is vital when anyone is undergoing any medical procedure or test. Individuals need to understand the testing procedure, the benefits and limitations of the test and potential consequences. This is particularly important for genetic tests that may not only provide information to an individual but also to their family. The genetic counselling process ensures an individual understands the process of testing and obtains permission to carry out the test.
Who can give informed consent?
In the situation of testing for adult onset inherited cancer predisposition gene testing informed consent can be given by the adult competent to make decisions for themselves. Genetic testing for children for adult onset cancer predisposition would not be undertaken in this service. In general testing children for conditions that would not have any clinical impact on them until adulthood is not performed for many reasons.
If an individual is not able to make their own medical decisions, for example an individual with impaired mental health, informed consent can be taken from their nominated guardian or the person with legal responsibility for making decisions on their behalf.
What is involved?
The consent for genomic testing does differ from other consent forms because the information has the potential to give other family members important information about their own likelihood of carrying an inherited predisposition to cancer. This information is important for them to have as they can then decide if they want more information about their own gene status and make sure they can access risk management option such as surveillance or risk reducing surgery. Although not everyone welcomes such information they do need the option to be able to get it and potentially avoid a cancer diagnosis.
It may not be easy to do this, particularly as some families can live far apart and not have much contact. How to inform family members can be discussed with the Genetic Counsellors.
How do I make informed consent?
The information discussed with you by the Genetic Counsellor and Specialists gives you what you need to know. Summary letters are always given to help you remember what was discussed. You also need to sign a specific genomic test consent form.
The information and consent form should include
- Information about the test – its purpose and why that test is suitable for you
- How and where the test is performed
- The potential outcomes of the test
- The meaning of those outcomes
- Clinical implications of the result (surveillance and surgical needs and options)
- Physical and emotional risks associated with the test
- If the result can be used for any research purpose
- If the result will provide information for other family members and potential risks to them
- Who the results will be reported to and what can and should be disclosed
- Unexpected results from any testing that may have a medical impact and why this may happen
- Any insurance implications to the person being tested and potential ones for direct family members
- What happens to the blood/DNA sample – where it goes and if it is stored and why
- That there has been an opportunity for any questions to be asked and answered and the test is not compulsory
- The consent form needs to be signed by the individual and health professional. This is a general overview, as some parts of the consent process will vary depending on the test being performed.