§34-14-21 TO §34-14-25. Medical Research.

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§34-14-21 TO §34-14-25. Medical Research.
Short Title
Official Text §34-14-21 TO §34-14-25. Medical Research.
Country/Jurisdiction United States
State or Province South Dakota
Regulatory Bodies
Date Enacted

Scope of the Law Health
Information

Taxonomy Decisional Interference, Interrogation
Strategies


Text of the law

34-14-21. Definition of terms used in §§ 34-14-21 to 34-14-24. Terms used in §§ 34-14-21 to 34-14-24, inclusive, mean:
(1) "Genetic information," information derived from a genetic test about a gene, gene product, or inherited characteristic;
(2) "Genetic test," a test of human DNA, RNA, chromosomes, or genes performed in order to identify the presence or absence of an inherited variation, alteration, or mutation which is associated with predisposition to disease, illness, impairment, or other disorder. Genetic test does not mean a routine physical measurement; a chemical, blood, or urine analysis; a test for drugs or HIV infection; any test commonly accepted in clinical practice; or any test performed due to the presence of signs, symptoms, or other manifestations of a disease, illness, impairment, or other disorder;
(3) "Predictive genetic test," a genetic test performed for the purpose of predicting the future probability that the person tested will develop a genetically related disease or disability.
34-14-22. Informed consent required prior to predictive genetic testing--Minimum requirements of written, informed consent. No person may order or perform a predictive genetic test without first obtaining the written, informed consent of the person to be tested. For purposes of this section, written, informed consent consists of a signed writing executed by the person to be tested or the legally authorized representative of the person to be tested that includes, at a minimum, all of the following:
(1) The nature and purpose of the predictive genetic test;
(2) The effectiveness and limitations of the predictive genetic test;
(3) The implications of taking the predictive genetic test, including, the medical risks and benefits;
(4) The future uses of the sample taken from the person tested in order to conduct the predictive genetic test and the information obtained from the predictive genetic test;
(5) The meaning of the predictive genetic test results and the procedure for providing notice of the results to the person tested; and
(6) A listing of who will have access to the sample taken from the person tested in order to conduct the predictive genetic test and the information obtained from the predictive genetic test, and the person's right to confidential treatment of the sample and the information.
34-14-23. Person to be tested to receive copy of signed consent form--Original signed form to be filed in medical records. If a person to be tested or the person's legally authorized representative signs a copy of the informed consent form developed pursuant to § 34-14-22, the person obtaining the informed consent shall give the person to be tested a copy of the signed informed consent form and shall include the original signed informed consent form in the medical record of the person tested.
34-14-24. Tests performed in pursuance of criminal investigation or court order not affected. Nothing in §§ 34-14-21 to 34-14-24, inclusive, or § 34-14-25, alters the ability to perform genetic tests done in pursuance of a lawful criminal investigation or court order.
34-14-25. Genetic testing to be performed by accredited laboratory enrolled in proficiency testing program--State health laboratory not affected. If a genetic test, as defined in § 34-14-21, is required or authorized by state law, or performed in the state, the test shall be performed in a laboratory accredited by the College of American Pathologists, the Joint Commission on Accreditation of Healthcare Organizations, or any accreditation body approved by the United States Secretary of Health and Human Services and which has requirements that are substantially equivalent to, or more comprehensive than, those of the College of American Pathologists. In addition, the laboratory shall be enrolled in a proficiency testing program sponsored by an organization approved by the Centers for Medicare and Medicaid Services. Nothing in this section alters the ability of the state health laboratory to perform genetic tests. Interrogation, Decisional Interference



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