N.Y. Public Health Law § 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.