[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR56.107]
[Page 297-298]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 56 INSTITUTIONAL REVIEW BOARDS--Table of Contents
Subpart B Organization and Personnel
Sec. 56.107 IRB membership.
(a) Each IRB shall have at least five members, with varying
backgrounds to promote complete and adequate review of research
activities commonly conducted by the institution. The IRB shall be
sufficiently qualified through the experience and expertise of its
members, and the diversity of the members, including consideration of
race, gender, cultural backgrounds, and sensitivity to such issues as
community attitudes, to promote respect for its advice and counsel in
safeguarding the rights and welfare of human subjects. In addition to
possessing the professional competence necessary to review the specific
research activities, the IRB shall be able to ascertain the
acceptability of proposed research in terms of institutional commitments
and regulations, applicable law, and standards or professional conduct
and practice. The IRB shall therefore include persons knowledgeable in
these areas. If an IRB regularly reviews research that involves a
vulnerable category of subjects, such as children, prisoners, pregnant
women, or handicapped or mentally disabled persons, consideration shall
be given to the inclusion of one or more individuals who are
knowledgeable about and experienced in working with those subjects.
(b) Every nondiscriminatory effort will be made to ensure that no
IRB
[[Page 298]]
consists entirely of men or entirely of women, including the
instituton's consideration of qualified persons of both sexes, so long
as no selection is made to the IRB on the basis of gender. No IRB may
consist entirely of members of one profession.
(c) Each IRB shall include at least one member whose primary
concerns are in the scientific area and at least one member whose
primary concerns are in nonscientific areas.
(d) Each IRB shall include at least one member who is not otherwise
affiliated with the institution and who is not part of the immediate
family of a person who is affiliated with the institution.
(e) No IRB may have a member participate in the IRB's initial or
continuing review of any project in which the member has a conflicting
interest, except to provide information requested by the IRB.
(f) An IRB may, in its discretion, invite individuals with
competence in special areas to assist in the review of complex issues
which require expertise beyond or in addition to that available on the
IRB. These individuals may not vote with the IRB.
[46 FR 8975, Jan 27, 1981, as amended at 56 FR 28028, June 18, 1991; 56
FR 29756, June 28, 1991]
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