Informed Consent

In the healthcare setting, the process of informed consent is a protection for patients. Prior to diagnostic testing or therapeutic intervention, the provider explains the procedure to the patient along with the risks, benefits, and alternatives so that the patient can voluntarily make informed decisions about diagnostic and treatment options.16 Depending on state law and laboratory standards, there is great variation in informed consent requirements for genetic testing. Position statements and guidelines for informed consent for genetic testing are available only for certain conditions or groups of conditions. The majority of guidelines exist for predisposition genetic testing. The National Society of Genetic Counselors recommends obtaining informed consent prior to predisposition genetic testing for adult-onset conditions.14 Guidelines for informed consent prior to genetic testing stress that this is

Table 3-2. Key Elements of Informed Consent for Genetic Testing Discussion of purpose of the test;procedures involved in testing

(blood drawing) Clinical utility of the test and interpretation of test results Discussion of risks, benefits, and limitations to testing (including psychosocial, cultural, and financial risks and benefits) Presentation of alternatives to genetic testing Procedure for communication of results Confidentiality of test results Voluntary nature of informed consent more than having a patient read and sign a piece of paper. Informed consent should be a communication process that fosters autonomous and informed decision making for the patient.17'18 Presentation of the key elements of informed consent (Table 3-2) needs to be tailored to the individual patient's learning style, educational and cultural background, and family situation to optimize the utility of informed consent. This is a time-intensive process that cannot routinely be done by primary care physicians during a routine office visit. The informed consent process also applies to genetic testing or collection of tissue or body fluids for research purposes.19

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