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This entry was published on 2014-09-22
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SECTION 79-L
Confidentiality of records of genetic tests
Civil Rights (CVR) CHAPTER 6, ARTICLE 7
§ 79-l. Confidentiality of records of genetic tests. 1. As used in
this section, the following terms shall have the following meanings:

(a) "genetic test" shall mean any laboratory test of human DNA,
chromosomes, genes, or gene products to diagnose the presence of a
genetic variation linked to a predisposition to a genetic disease or
disability in the individual or the individual's offspring; such term
shall also include DNA profile analysis. "Genetic test" shall not be
deemed to include any test of blood or other medically prescribed test
in routine use that has been or may be hereafter found to be associated
with a genetic variation, unless conducted purposely to identify such
genetic variation.

(b) "genetic predisposition" shall mean the presence of a variation in
the composition of the genes of an individual or an individual's family
member which is scientifically or medically identifiable and which is
determined to be associated with an increased statistical risk of being
expressed as either a physical or mental disease or disability in the
individual or having offspring with a genetically influenced disease,
but which has not resulted in any symptoms of such disease or disorder.

(c) "biological sample" shall mean any material part of the human body
or of discharge therefrom known to contain DNA, including but not
limited to tissue specimen, blood, or urine.

(d) "institutional review board" shall mean a human research review
committee established and approved under the provisions of article
twenty-four-A of the public health law, or an institutional review board
established and approved under the provisions of 45 CFR part 46 or 42
USC 30 V-1, for the purpose of reviewing and monitoring research
involving human subjects.

2. (a) No person shall perform a genetic test on a biological sample
taken from an individual without the prior written informed consent of
such individual as provided in paragraph (b) of this subdivision, except
as otherwise provided in paragraph (c) of subdivision two and by
subdivision nine of this section.

(b) Written informed consent to a genetic test shall consist of
written authorization that is dated and signed and includes at least the
following:

(1) a general description of the test;

(2) a statement of the purpose of the test;

2-a. a statement indicating that the individual may wish to obtain
professional genetic counseling prior to signing the informed consent.

(3) a statement that a positive test result is an indication that the
individual may be predisposed to or have the specific disease or
condition tested for and may wish to consider further independent
testing, consult their physician or pursue genetic counseling;

(4) a general description of each specific disease or condition tested
for;

(5) the level of certainty that a positive test result for that
disease or condition serves as a predictor of such disease. If no level
of certainty has been established, this subparagraph may be disregarded;

(6) the name of the person or categories of persons or organizations
to whom the test results may be disclosed;

(7) a statement that no tests other than those authorized shall be
performed on the biological sample and that the sample shall be
destroyed at the end of the testing process or not more than sixty days
after the sample was taken, unless a longer period of retention is
expressly authorized in the consent; and

(8) the signature of the individual subject of the test or, if that
individual lacks the capacity to consent, the signature of the person
authorized to consent for such individual.

(c) A general waiver, wherein consent is secured for genetic testing
without compliance with paragraph (b) of this subdivision, shall not
constitute informed consent. Notwithstanding the provisions of this
section, for purposes of research conducted in accordance with the
provisions of subdivision nine of this section, a general waiver for the
use of samples for research may be granted which would authorize the use
of samples for these research purposes.

(d) Any further disclosure of genetic test results to persons or
organizations not named on the informed consent shall require the
further informed consent of the subject of the test.

(e) Written consent by an individual for tests to be conducted on a
biological sample and to the lawful possession and ownership of such
sample by a laboratory shall not be deemed written informed consent for
the performance of any genetic test on that sample, except as further
provided in subdivision four of this section.

(f) For medical research purposes, with the approval of an
institutional review board and the written informed consent of the
subject, samples may be kept for longer than sixty days and utilized for
scientific research. The requirements of subparagraphs three, four and
five of paragraph (b) of this subdivision may be modified by the
institutional review board in case the research protocol does not permit
such degree of specificity.

3. (a) All records, findings and results of any genetic test performed
on any person shall be deemed confidential and shall not be disclosed
without the written informed consent of the person to whom such genetic
test relates. This information shall not be released to any person or
organization not specifically authorized by the individual subject of
the test. Unauthorized solicitation or possession of such information
shall be unlawful, except for the unintentional possession of such
information as part of a health record created prior to the effective
date of this section and provided no action adverse to the interests of
the subject are taken as a result of such possession. Nothing in this
section shall preclude the release of such information, with the
subject's consent, to a health insurer or health maintenance
organization of any information reasonably required for purposes of
claims administration, provided, however, that further distribution
within the insurer or to other recipients shall require the subject's
informed consent in each case.

(b) No person who lawfully possesses information derived from a
genetic test on a biological sample from an individual shall incorporate
such information into the records of a non-consenting individual who may
be genetically related to the tested individual; nor shall any
inferences be drawn, used, or communicated regarding the possible
genetic status of the non-consenting individual.

4. (a) Notwithstanding the provisions of subdivision two of this
section, genetic tests may be performed on anonymous samples for
research or statistical purposes, pursuant to a research protocol
approved by an institutional review board which assures the anonymity of
the sources of the samples.

(b) Notwithstanding the provisions of subdivision two of this section,
genetic tests may be performed without the consent of the person who is
the subject of the tests pursuant to an order of a court of competent
jurisdiction or as provided pursuant to article forty-nine-B of the
executive law or as provided by section twenty-five hundred-a of the
public health law.

(c) Notwithstanding the provisions of paragraph (a) of subdivision
three of this section, the results of a genetic test may be disclosed to
specified individuals without the consent of the subject of the test as
provided in an order of a court of competent jurisdiction or as provided
pursuant to article forty-nine-B of the executive law or section
twenty-five hundred-a of the public health law.

(d) In authorizing a genetic test or the disclosure of genetic test
results to specified individuals, the court shall consider the privacy
interests of the individual subject of the genetic test and of close
relatives of such individual, the public interest, and, in the case of
medical or anthropological research, the ethical appropriateness of the
research. Disclosure shall be permitted only to individuals or agencies
expressly named in court orders.

5. Penalties. (a) Any person who violates the provisions of
subdivision two or three of this section shall be guilty of a violation
punishable by a civil fine of not more than one thousand dollars.

(b) Any person who willfully violates the provisions of subdivision
two or three of this section shall be guilty of a misdemeanor punishable
by a fine of not more than five thousand dollars or by imprisonment for
not more than ninety days or by both such fine and imprisonment.

6. Nothing in this section shall be applicable to an authorized
insurer, as defined in paragraph ten of subsection (a) of section one
hundred seven of the insurance law, or a person acting on behalf of an
authorized insurer who is in compliance with section twenty-six hundred
twelve of the insurance law nor shall anything in this section be deemed
to prohibit or limit an authorized insurer from obtaining information
pursuant to section twenty-six hundred twelve of the insurance law.

7. Notwithstanding the provisions of subdivision two of this section,
genetic testing of newborn infants may be performed as provided pursuant
to article twenty-five and section forty-one hundred thirty-five-b of
the public health law.

8. Notwithstanding the provisions of subparagraph seven of paragraph
(b) of subdivision two of this section, additional genetic testing may
be performed on a given sample without additional consent of the person
tested provided such testing is necessary and required to demonstrate
the integrity of the sample tested or to resolve the analysis of a test
with a previously indeterminate result.

9. (a) Notwithstanding the provisions of subdivisions two and ten of
this section, samples may be used for tests other than those for which
specific consent has been obtained, for purposes of research conducted
in accordance with applicable law and regulation and pursuant to a
research protocol approved by an institutional review board, provided
that the individuals who provided the samples have given prior written
informed consent for the use of their sample for general research
purposes and did not specify time limits or other factors that would
restrict use of the sample for the test, and (1) the samples have been
permanently stripped of identifying information; or (2) a coding system
has been established to protect the identity of the individuals who
provided the samples, and an institutional review board has reviewed and
approved the procedures for the coding system.

(b) If consent to storage of the tissue sample is withdrawn at any
time, the entity storing the sample shall promptly destroy the sample or
portions thereof that have not already been used for research purposes.

(c) In no event shall family members of an individual who provided a
stored tissue sample be contacted for clinical, research, or other
purposes without consent from the individual who provided the tissue
sample with respect to the specific family members who will be contacted
and the specific purpose of the contact.

(d) In no event shall any information about an individual derived from
genetic tests performed on stored human tissue or information linking an
individual with specific results of genetic tests be released to any
organization or person without the explicit written consent of the
individual who donated the stored tissue to release of the information
for the purposes set forth in the written consent document.

(e) Written informed consent for use of stored human tissue for
general research purposes shall consist of written authorization that
includes at least the following:

(1) a statement that the sample will be used for future genetic tests;

(2) the time period during which the tissue will be stored, or if no
time limit is specified, a statement that the tissue will be stored for
as long as deemed useful for research purposes;

(3) a description of the policies and procedures to protect patient
confidentiality;

(4) a statement of the right to withdraw consent to use of the tissue
for future use at any time and the name of the organization that should
be contacted to withdraw consent;

(5) a statement allowing individuals to consent to future contact for
any or all purposes, including the following: (i) research purposes;
(ii) provision of general information about research findings; and (iii)
information about the test on their sample that may benefit them or
their family members in relation to their choices regarding preventive
or clinical care; and

(6) a statement explaining the benefits and risks of consenting to
future contact for the purposes set forth in subparagraph five of this
paragraph. In no event shall information about specific test results on
stored human tissue donated for general research purposes be disclosed
to an individual without obtaining informed consent for the disclosure
as required by paragraph (b) of subdivision two of this section.

10. Notwithstanding the provisions of subdivision two of this section,
DNA samples may be stored for up to ten years in the absence of genetic
testing, if authorized in writing by the subject. Prior to the
performance of any genetic test upon stored samples, informed consent
must be obtained as provided in subdivision two of this section.
Retention of a DNA sample past a period of ten years requires explicit
consent for a longer or indefinite period of retention.

11. Genetic testing may be performed on specimens from deceased
persons if informed consent is provided by the next-of-kin as specified
in subdivision two of this section.