What is informed consent?
Informed consent means that you know enough about the test to make a good decision for yourself or your minor child. It’s important that you have a good understanding about how you will use the results. Informed consent is more than simply reading and signing a consent form. “Informed consent” can be broken down into its two parts:
“Informed” means that you have enough information to make an educated decision about undergoing a genetic test
“Consent” means that you voluntary agree to have the test done.
Before you agree to a genetic test, it is important to fully understand the testing procedure, the benefits and limitations of the test, and the possible uses and consequences of the test results. Your consent also gives your medical professional permission to carry out the genetic test on your behalf.
Legally, informed consent can only be given in two ways:
Adults can give their own informed consent if they are able to make medical decisions for themselves
A parent, guardian, or other legally responsible person can give informed consent for children and others who are unable to make their own medical decisions
Informed consent for genetic testing is generally obtained by a doctor or genetic counselor during an office visit. The healthcare provider will discuss the test and answer any questions. If you wish to have the test, you will then usually read and sign a consent form.
Consent forms vary, but often include a description of the test, including:
The genetic condition for which the testing is being performed,
How the test will be carried out (for example, a blood sample or an oral rinse), and
Consent forms may also explain:
Physical or emotional risks associated with the test.
Implications for family members including the risk of developing a particular condition or the possibility of having affected children.
Your plan for results disclosure – how will you receive the results,to whom will results be reported and under what circumstances results can be disclosed (for example, to health insurance providers).
What will happen to the test specimen after the test is complete, including whether the results can be used for research purposes.
Before you undergo genetic testing, the consent form may ask you to sign the form to affirm that you have had the opportunity to discuss the test with a healthcare professional and that you would like to proceed with the test.
Informed consent is not a contract.
You have the right to change your mind at any time after giving your initial consent, even after the test sample has been collected. You may also choose not to receive your results, even if the test has been completed. Simply notify your healthcare provider to stop the testing process.
1) What are the benefits and risks of genetic testing?
2) How does genetic testing work?
3) What is the cost of genetic testing?
4) What have others experienced with genetic testing?
Informed Consent for Hereditary Colon Cancer Syndromes
Development of this resource was generously supported by Myriad Genetics.