N.Y. Civil Rights Law § 79-l: Confidentiality of records of genetic tests

§ 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.