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This entry was published on 2014-09-22
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Public Health (PBH) CHAPTER 45, ARTICLE 24-A
§ 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.