This summary of state laws does not include full citations for statutes that prohibit discrimination in employment or insurance on the basis of genetic testing or genetic information. There are other comprehensive collections of state laws addressing genetic nondiscrimination in employment and insurance. Therefore, there are complete references only where the statute is relevant for the conduct of research using tissue specimens.
According to the New York law, genetic tests generally cannot be performed on a biological sample taken from an individual without the prior written informed consent of the individual. An informed consent must contain, among other things, the name of the person or categories of persons or organizations to whom the test results may be disclosed. Genetic testing may be performed on specimens from deceased persons if informed consent is provided by the next of kin. The statute defines “biological samples” as “any material part of the human body or of discharge therefrom known to contain DNA, including but not limited to tissue specimens, blood, or urine.”
[McKinney’s Consolidated Laws of New York Annotated, Section 79-l]
Authors’ note: Arkansas and Oklahoma utilize similar statutes that permit the use of excess surgical and diagnostic tissue (and blood) for genetic research or other research studies as long as patient privacy is assured.
Insurers must obtain informed consent prior to performing genetic testing. [McKinney’s Consolidated Laws of New York Annotated, Section 2612].
“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.
[McKinney’s Consolidated Laws of New York Annotated, Section 79-l].
New York state public health statutes include an explicit requirement to obtain informed consent and to review research for studies not otherwise covered by the federal regulations. New York’s law on human subject protection exempts from the definition of human research “biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or for epidemiological investigations.” By carving out tissue taken exclusively for research purposes, or excess surgical or diagnostic tissue, New York permits the use of tissue samples in research, without the attendant requirements for specific informed consent and review of the research. [McKinney’s Public Health Law 2440]
The New York state human subject legislation addresses tissue research, stating that some tissue research is not considered to be human subject research. [McKinney’s Public Health Law 2441]
“Human research” means any medical experiments, research, or scientific or psychological investigation, which utilizes human subjects and which involves physical or psychological intervention by the researcher upon the body of the subject and which is not required for the purposes of obtaining information for the diagnosis, prevention, or treatment of disease or the assessment of medical condition for the direct benefit of the subject. Human research shall not, however, be construed to mean the conduct of biological studies exclusively utilizing tissue or fluids after their removal or withdrawal from a human subject in the course of standard medical practice, or to include epidemiological investigations. “Fluid” means a normal body excretion or any fluid formed by normal or pathological body processes obtained during diagnostic or therapeutic procedures conducted for the benefit of the human subject. “Tissue” means part or all of any organ of a human subject removed during a diagnostic or therapeutic procedure conducted for the benefit of the human subject. [McKinney’s Public Health Law 2440]