§ 2441 — Definitions

§ 2441. Definitions. For the purposes of this article: 1. "Human\nsubject" shall mean any individual who may be exposed to the possibility\nof injury, including physical, psychological or social injury, as a\nconsequence of participation as a subject in any research, development,\nor related activity which departs from the application of those\nestablished and accepted methods necessary to meet his needs or which\nincreases the ordinary risk of daily life including the reecognized\nrisks inherent in a chosen occupation or field of service.\n 2. "Human research" means any medical experiments, research, or\nscientific or psychological investigation, which utilizes human subjects\nand which involves physical or psychological intervention by the\nresearcher upon the body of the subject and which is not required for\nthe purposes of obtaining information for the diagnosis, prevention, or\ntreatment of disease or the assessment of medical condition for the\ndirect benefit of the subject. Human research shall not, however, be\nconstrued to mean the conduct of biological studies exclusively\nutilizing tissue or fluids after their removal or withdrawal from a\nhuman subject in the course of standard medical practice, or to include\nepidemiological investigations.\n 3. "Fluid" means a normal body excretion or any fluid formed by normal\nor pathological body processes obtained during diagnostic or therapeutic\nprocedures conducted for the benefit of the human subject.\n 4. "Tissue" means part or all of any organ of a human subject removed\nduring a diagnostic or therapeutic procedure conducted for the benefit\nof the human subject.\n 5. "Voluntary informed consent" means the legally effective knowing\nconsent of an individual or his legally authorized representative, so\nsituated as to be able to exercise free power of choice without undue\ninducement or any element of force, fraud, deceit, duress or other form\nof constraint or coercion. With regard to the conduct of human research,\nthe basic elements of information necessary to such consent include:\n (a) a fair explanation to the individual of the procedures to be\nfollowed, and their purposes, including identification of any procedures\nwhich are experimental;\n (b) a description of any attendant discomforts and risks reasonably to\nbe expected;\n (c) a description of any benefits reasonably to be expected;\n (d) a disclosure of any appropriate alternative procedures that might\nbe advantageous for the individual;\n (e) an offer to answer any inquiries by the individual concerning the\nprocedures; and\n (f) an instruction that the individual is free to withdraw his consent\nand to discontinue participation in the human research at any time\nwithout prejudice to him.\n 6. "Researcher" means any person licensed under title VIII of the\neducation law to perform diagnosis, treatment, medical services,\nprescription or therapeutic exercises with regard to or upon human\nbeings, or any other person deemed appropriately competent and qualified\nby a human research review committee as provided by section twenty-four\nhundred forty-four of this chapter.\n