N.Y. Public Health Law § 2444: Human research review committees

§ 2444. Human research review committees. 1. Each public or private

institution or agency which conducts, or which proposes to conduct or

authorize, human research, shall establish a human research review

committee. Such committee shall be composed of not less than five

persons, approved by the commissioner, who have such varied backgrounds

as to assure the competent, complete and professional review of human

research activities conducted or proposed to be conducted or authorized

by the institution or agency. No member of a committee shall be involved

in either the initial or continuing review of an activity in which he

has a conflicting interest, except to provide information required by

the committee. No committee shall consist entirely of persons who are

officers, employees, or agents of, or who are otherwise associated with

the institution or agency, apart from their membership on the committee,

and no committee shall consist entirely of members of a single

professional group.

2. The human research review committee in each institution or agency

shall require that institution or agency to promulgate a statement of

principle and policy in regard to the rights and welfare of human

subjects in the conduct of human research, and the committee and the

commissioner shall approve that statement prior to its taking effect.

The committee shall review each proposed human research project to

determine (1) its necessity; (2) that the rights and welfare of the

human subjects involved are adequately protected, (3) that the risks to

the human subjects are outweighed by the potential benefits to them or

by the importance of the knowledge to be gained; (4) that the voluntary

informed consent is to be obtained by methods that are adequate and

appropriate, and (5) that the persons proposed to conduct the particular

medical research are appropriately competent and qualified. The

committee shall periodically examine each existing human research

project with regard to the proper application of the approved principles

and policies which the institution or agency has promulgated. The

committee shall report any violation to the commissioner. In addition to

the voluntary informed consent of the proposed human subject as required

by section twenty-four hundred forty-two of this chapter, the consent of

the committee and the commissioner shall be required with relation to

the conduct of human research involving minors, incompetent persons,

mentally disabled persons and prisoners.

3. Each person engaged in the conduct of human research or proposing

to conduct human research shall affiliate himself with an institution or

agency having a human research review committee, and such human research

as he conducts or proposes to conduct shall be subject to review by such

committee in the manner set forth in this section.