Section 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.