QUESTIONS

1. What is a “genetic test”?
   
   
2. Who can order a genetic test?
   
   
3. Are there documentation requirements that must accompany a genetic test?
   
   
4. What are the required components of this written consent?
   
   
5. Where do I obtain such a consent form?

ANSWERS

What is a “genetic test”?
A genetic test is a test of human DNA, RNA, mitochondrial DNA, chromosomes or proteins for the purpose of identifying genes, inherited or acquired genetic abnormalities, or the presence or absence of inherited or acquired characteristics in genetic material.  Under Massachusetts law, heightened protection is given to the performance of genetic tests and the disclosure of any test results.  This heightened protection does not apply to tests given for drugs, alcohol, cholesterol, or HIV; or any test for the purpose of diagnosing or detecting an existing disease, illness, impairment or disorder.

Who can order a genetic test?
Any physician (or incident to physician) can order a genetic test.

Are there documentation requirements that must accompany a genetic test?
Prior written consent must be obtained.  Prior written consent is a written consent form signed by the person who is the subject of the test or, if that person lacks capacity to consent, signed by the person authorized to consent for such person.  The consent must be specific and contain certain required components (see below); it cannot be a general waiver or a general consent for genetic testing.

What are the required components of this written consent?

1. a statement of the purpose of the test;
   
2. a statement that prior to signing the consent form, the consenting person discussed with the medical practitioner ordering the test the reliability of positive or negative test results and the level of certainty that a positive test result for that disease or condition serves as a predictor of such disease;
3. a statement that the consenting person was informed about the availability and importance of genetic counseling and provided with written information identifying a genetic counselor or medical geneticist from whom the consenting person might obtain such counseling;
4. a general description of each specific disease or condition tested for; and
5. the person or persons to whom the test results may be disclosed

Where do I obtain such a consent form?
The Massachusetts General Hospital Center for Cancer Risk Assessment (CCRA) has consent forms that have been approved for use.  We strongly encourage that all patients seeking this test be referred to the CCRA to receive counseling and an informed consent process that complies with applicable state requirements.  It is important to note that consent forms that are provided by genetic testing laboratories may not comply with Massachusetts State law, and should be used only with extreme caution.