§ 79-L — Confidentiality of records of genetic tests

§ 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 section, a general waiver for the\nuse of samples for research may be granted which would authorize the use\nof samples for these research purposes.\n (d) Any further disclosure of genetic test results to persons or\norganizations not named on the informed consent shall require the\nfurther informed consent of the subject of the test.\n (e) Written consent by an individual for tests to be conducted on a\nbiological sample and to the lawful possession and ownership of such\nsample by a laboratory shall not be deemed written informed consent for\nthe performance of any genetic test on that sample, except as further\nprovided in subdivision four of this section.\n (f) For medical research purposes, with the approval of an\ninstitutional review board and the written informed consent of the\nsubject, samples may be kept for longer than sixty days and utilized for\nscientific research. The requirements of subparagraphs three, four and\nfive of paragraph (b) of this subdivision may be modified by the\ninstitutional review board in case the research protocol does not permit\nsuch degree of specificity.\n 3. (a) All records, findings and results of any genetic test performed\non any person shall be deemed confidential and shall not be disclosed\nwithout the written informed consent of the person to whom such genetic\ntest relates. This information shall not be released to any person or\norganization not specifically authorized by the individual subject of\nthe test. Unauthorized solicitation or possession of such information\nshall be unlawful, except for the unintentional possession of such\ninformation as part of a health record created prior to the effective\ndate of this section and provided no action adverse to the interests of\nthe subject are taken as a result of such possession. Nothing in this\nsection shall preclude the release of such information, with the\nsubject's consent, to a health insurer or health maintenance\norganization of any information reasonably required for purposes of\nclaims administration, provided, however, that further distribution\nwithin the insurer or to other recipients shall require the subject's\ninformed consent in each case.\n (b) No person who lawfully possesses information derived from a\ngenetic test on a biological sample from an individual shall incorporate\nsuch information into the records of a non-consenting individual who may\nbe genetically related to the tested individual; nor shall any\ninferences be drawn, used, or communicated regarding the possible\ngenetic status of the non-consenting individual.\n 4. (a) Notwithstanding the provisions of subdivision two of this\nsection, genetic tests may be performed on anonymous samples for\nresearch or statistical purposes, pursuant to a research protocol\napproved by an institutional review board which assures the anonymity of\nthe sources of the samples.\n (b) Notwithstanding the provisions of subdivision two of this section,\ngenetic tests may be performed without the consent of the person who is\nthe subject of the tests pursuant to an order of a court of competent\njurisdiction or as provided pursuant to article forty-nine-B of the\nexecutive law or as provided by section twenty-five hundred-a of the\npublic health law.\n (c) Notwithstanding the provisions of paragraph (a) of subdivision\nthree of this section, the results of a genetic test may be disclosed to\nspecified individuals without the consent of the subject of the test as\nprovided in an order of a court of competent jurisdiction or as provided\npursuant to article forty-nine-B of the executive law or section\ntwenty-five hundred-a of the public health law.\n (d) In authorizing a genetic test or the disclosure of genetic test\nresults to specified individuals, the court shall consider the privacy\ninterests of the individual subject of the genetic test and of close\nrelatives of such individual, the public interest, and, in the case of\nmedical or anthropological research, the ethical appropriateness of the\nresearch. Disclosure shall be permitted only to individuals or agencies\nexpressly named in court orders.\n 5. Penalties. (a) Any person who violates the provisions of\nsubdivision two or three of this section shall be guilty of a violation\npunishable by a civil fine of not more than one thousand dollars.\n (b) Any person who willfully violates the provisions of subdivision\ntwo or three of this section shall be guilty of a misdemeanor punishable\nby a fine of not more than five thousand dollars or by imprisonment for\nnot more than ninety days or by both such fine and imprisonment.\n 6. Nothing in this section shall be applicable to an authorized\ninsurer, as defined in paragraph ten of subsection (a) of section one\nhundred seven of the insurance law, or a person acting on behalf of an\nauthorized insurer who is in compliance with section twenty-six hundred\ntwelve of the insurance law nor shall anything in this section be deemed\nto prohibit or limit an authorized insurer from obtaining information\npursuant to section twenty-six hundred twelve of the insurance law.\n 7. Notwithstanding the provisions of subdivision two of this section,\ngenetic testing of newborn infants may be performed as provided pursuant\nto article twenty-five and section forty-one hundred thirty-five-b of\nthe public health law.\n 8. Notwithstanding the provisions of subparagraph seven of paragraph\n(b) of subdivision two of this section, additional genetic testing may\nbe performed on a given sample without additional consent of the person\ntested provided such testing is necessary and required to demonstrate\nthe integrity of the sample tested or to resolve the analysis of a test\nwith a previously indeterminate result.\n 9. (a) Notwithstanding the provisions of subdivisions two and ten of\nthis section, samples may be used for tests other than those for which\nspecific consent has been obtained, for purposes of research conducted\nin accordance with applicable law and regulation and pursuant to a\nresearch protocol approved by an institutional review board, provided\nthat the individuals who provided the samples have given prior written\ninformed consent for the use of their sample for general research\npurposes and did not specify time limits or other factors that would\nrestrict use of the sample for the test, and (1) the samples have been\npermanently stripped of identifying information; or (2) a coding system\nhas been established to protect the identity of the individuals who\nprovided the samples, and an institutional review board has reviewed and\napproved the procedures for the coding system.\n (b) If consent to storage of the tissue sample is withdrawn at any\ntime, the entity storing the sample shall promptly destroy the sample or\nportions thereof that have not already been used for research purposes.\n (c) In no event shall family members of an individual who provided a\nstored tissue sample be contacted for clinical, research, or other\npurposes without consent from the individual who provided the tissue\nsample with respect to the specific family members who will be contacted\nand the specific purpose of the contact.\n (d) In no event shall any information about an individual derived from\ngenetic tests performed on stored human tissue or information linking an\nindividual with specific results of genetic tests be released to any\norganization or person without the explicit written consent of the\nindividual who donated the stored tissue to release of the information\nfor the purposes set forth in the written consent document.\n (e) Written informed consent for use of stored human tissue for\ngeneral research purposes shall consist of written authorization that\nincludes at least the following:\n (1) a statement that the sample will be used for future genetic tests;\n (2) the time period during which the tissue will be stored, or if no\ntime limit is specified, a statement that the tissue will be stored for\nas long as deemed useful for research purposes;\n (3) a description of the policies and procedures to protect patient\nconfidentiality;\n (4) a statement of the right to withdraw consent to use of the tissue\nfor future use at any time and the name of the organization that should\nbe contacted to withdraw consent;\n (5) a statement allowing individuals to consent to future contact for\nany or all purposes, including the following: (i) research purposes;\n(ii) provision of general information about research findings; and (iii)\ninformation about the test on their sample that may benefit them or\ntheir family members in relation to their choices regarding preventive\nor clinical care; and\n (6) a statement explaining the benefits and risks of consenting to\nfuture contact for the purposes set forth in subparagraph five of this\nparagraph. In no event shall information about specific test results on\nstored human tissue donated for general research purposes be disclosed\nto an individual without obtaining informed consent for the disclosure\nas required by paragraph (b) of subdivision two of this section.\n 10. Notwithstanding the provisions of subdivision two of this section,\nDNA samples may be stored for up to ten years in the absence of genetic\ntesting, if authorized in writing by the subject. Prior to the\nperformance of any genetic test upon stored samples, informed consent\nmust be obtained as provided in subdivision two of this section.\nRetention of a DNA sample past a period of ten years requires explicit\nconsent for a longer or indefinite period of retention.\n 11. Genetic testing may be performed on specimens from deceased\npersons if informed consent is provided by the next-of-kin as specified\nin subdivision two of this section.\n