NY Pub Health L § 2441 (2021)
2021 New York Laws PBH - Public Health Article 24-A - Protection of Human Subjects 2441 - Definitions.

§  2441.  Definitions.    For the purposes of this article: 1.  "Human subject" shall mean any individual who may be exposed to the possibility of injury, including physical, psychological  or  social  injury,  as  a consequence  of participation as a subject in any research, development, or  related  activity  which  departs  from  the  application  of  those established  and  accepted  methods necessary to meet his needs or which increases the ordinary risk of  daily  life  including  the  reecognized risks inherent in a chosen occupation or field of service.   2.  "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.   3. "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.   4. "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.   5. "Voluntary informed consent" means the  legally  effective  knowing consent  of  an  individual or his legally authorized representative, so situated as to be able to exercise free power of  choice  without  undue inducement  or any element of force, fraud, deceit, duress or other form of constraint or coercion. With regard to the conduct of human research, the basic elements of information necessary to such consent include:  (a) a fair explanation to the  individual  of  the  procedures  to  be followed, and their purposes, including identification of any procedures which are experimental;  (b) a description of any attendant discomforts and risks reasonably to be expected;  (c) a description of any benefits reasonably to be expected;  (d)  a disclosure of any appropriate alternative procedures that might be advantageous for the individual;  (e) an offer to answer any inquiries by the individual concerning  the procedures; and  (f) an instruction that the individual is free to withdraw his consent and  to  discontinue  participation  in  the  human research at any time without prejudice to him.   6. "Researcher" means any person licensed  under  title  VIII  of  the education   law  to  perform  diagnosis,  treatment,  medical  services, prescription or therapeutic exercises  with  regard  to  or  upon  human beings, or any other person deemed appropriately competent and qualified by  a human research review committee as provided by section twenty-four hundred forty-four of this chapter.