New York CVR Code § 79-L

Confidentiality of records of genetic tests
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§ 79-l. Confidentiality of records of genetic tests. 1. As used in\nthis section, the following terms shall have the following meanings:\n  (a) "genetic test" shall mean any laboratory test of human DNA,\nchromosomes, genes, or gene products to diagnose the presence of a\ngenetic variation linked to a predisposition to a genetic disease or\ndisability in the individual or the individual's offspring; such term\nshall also include DNA profile analysis. "Genetic test" shall not be\ndeemed to include any test of blood or other medically prescribed test\nin routine use that has been or may be hereafter found to be associated\nwith a genetic variation, unless conducted purposely to identify such\ngenetic variation.\n  (b) "genetic predisposition" shall mean the presence of a variation in\nthe composition of the genes of an individual or an individual's family\nmember which is scientifically or medically identifiable and which is\ndetermined to be associated with an increased statistical risk of being\nexpressed as either a physical or mental disease or disability in the\nindividual or having offspring with a genetically influenced disease,\nbut which has not resulted in any symptoms of such disease or disorder.\n  (c) "biological sample" shall mean any material part of the human body\nor of discharge therefrom known to contain DNA, including but not\nlimited to tissue specimen, blood, or urine.\n  (d) "institutional review board" shall mean a human research review\ncommittee established and approved under the provisions of article\ntwenty-four-A of the public health law, or an institutional review board\nestablished and approved under the provisions of 45 CFR part 46 or 42\nUSC 30 V-1, for the purpose of reviewing and monitoring research\ninvolving human subjects.\n  2. (a) No person shall perform a genetic test on a biological sample\ntaken from an individual without the prior written informed consent of\nsuch individual as provided in paragraph (b) of this subdivision, except\nas otherwise provided in paragraph (c) of subdivision two and by\nsubdivision nine of this section.\n  (b) Written informed consent to a genetic test shall consist of\nwritten authorization that is dated and signed and includes at least the\nfollowing:\n  (1) a general description of the test;\n  (2) a statement of the purpose of the test;\n  2-a. a statement indicating that the individual may wish to obtain\nprofessional genetic counseling prior to signing the informed consent.\n  (3) a statement that a positive test result is an indication that the\nindividual may be predisposed to or have the specific disease or\ncondition tested for and may wish to consider further independent\ntesting, consult their physician or pursue genetic counseling;\n  (4) a general description of each specific disease or condition tested\nfor;\n  (5) the level of certainty that a positive test result for that\ndisease or condition serves as a predictor of such disease. If no level\nof certainty has been established, this subparagraph may be disregarded;\n  (6) the name of the person or categories of persons or organizations\nto whom the test results may be disclosed;\n  (7) a statement that no tests other than those authorized shall be\nperformed on the biological sample and that the sample shall be\ndestroyed at the end of the testing process or not more than sixty days\nafter the sample was taken, unless a longer period of retention is\nexpressly authorized in the consent; and\n  (8) the signature of the individual subject of the test or, if that\nindividual lacks the capacity to consent, the signature of the person\nauthorized to consent for such individual.\n  (c) A general waiver, wherein consent is secured for genetic testing\nwithout compliance with paragraph (b) of this subdivision, shall not\nconstitute informed consent. Notwithstanding the provisions of this\nsection, for purposes of research conducted in accordance with the\nprovisions of subdivision nine of this secti

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