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What is informed consent?
Before a person has a genetic test, it is important that he or she fully understands the testing procedure, the benefits and limitations of the test, and the possible consequences of the test results. The process of educating a person about the test and obtaining permission to carry out testing is called informed consent. “Informed” means that the person has enough information to make an educated decision about testing; “consent” refers to a person’s voluntary agreement to have the test done.
In general, informed consent can only be given by adults who are competent to make medical decisions for themselves. For children and others who are unable to make their own medical decisions (such as people with impaired mental status), informed consent can be given by a parent, guardian, or other person legally responsible for making decisions on that person’s behalf.
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 the person wishes to have the test, he or she will then usually read and sign a consent form.
Several factors are commonly included on an informed consent form:
The elements of informed consent may vary, because some states have laws that specify factors that must be included. (For example, some states require disclosure that the test specimen will be destroyed within a certain period of time after the test is complete.)
Informed consent is not a contract, so a person can change his or her mind at any time after giving initial consent. A person may choose not to go through with genetic testing even after the test sample has been collected. A person simply needs to notify the healthcare provider if he or she decides not to continue with the testing process.
For more information about informed consent:
MedlinePlus offers general information about informed consent by
The National Cancer Institute discusses informed consent for genetic testing in the context of inherited cancer
The National Human Genome Research Institute provides information about informed consent in genomics
The Centers for Disease Control and Prevention offers several examples of state-required components of informed consent for genetic
Additional information about informed