Informed Consent during Genetic Testing

The consent form should include the benefits, risks, and limitations to genetic testing. A copy of the consent form should be provided to the patient. Informed consent, however, is best described as a process and not just a piece of paper to be signed by the patient. Informed consent allows a patient to make fully educated healthcare decisions.

Informed consent generally includes the following:

• Discussion of the patient's expectations, beliefs, goals, and motivation
• Explanation of how inheritance of genetic factors may affect disease susceptibility
• Clarification of the patient's increased risk status
• Discussion of potential benefits, risks, and limitations of testing
• Discussion of costs and logistics of testing and follow-up
• Discussion of possible outcomes of testing, e.g., positive, negative, inconclusive, true positive, false positive
• Discussion of medical options available for those who choose or don't choose testing and for those who have positive, negative, or inconclusive results
• Provision of data on efficacy of methods of disease prevention and early detection
• Discussion of possible psychological, social, economic, and family ramifications of testing or not testing
• Consideration of how the person's screening or other behaviors might change, depending on the test result
• Discussion of alternatives to genetic testing, e.g., tissue banking, risk assessment
• Obtaining verbal and written informed consent or clarifying the decision to decline testing
• Consideration of personal acceptability of surveillance and risk reduction options
  
  (National Cancer Institute, 2003)