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