Informed Consent Compliance
for Germline Genetic Testing
If you prefer, you can download a PDF
of a blanket or patient consent to fill out, sign and fax back to 844-595-4288.
Background
Some state laws require that individuals (or their authorized representative) provide written informed consent to the physician performing germline
genetic testing and/or releasing test results.
The individual (or authorized person) must sign and date a consent form that includes:
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- Statement of test purpose and description.
- Statement that prior to testing, the physician ordering the test discussed with the individual the reliability of positive/negative test
results and the level of certainty that a positive result for the disease or condition serves as a predictor of such disease.
- Statement that the physician informed the individual about availability and importance of further testing, physician consultation and
genetic counseling, and provided written information identifying a genetic counselor or medical geneticist.
- General description of each disease or condition for which a test is ordered.
- The name of the person or persons to whom the test results may be disclosed.
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Physician Attestation of Informed Consent (PAIC)