2023 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.