Human Research Protection Program: Policy
IRB Composition
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: January 22, 2009
Purpose: The
UW-Madison IRB rosters describe the composition of the UW-Madison IRBs and
assist the IRBs in assuring compliance with federal regulations.
Policy
I. UW-Madison complies with the DHHS and
FDA regulations governing the composition of IRBs and the content of IRB
rosters.
II. Each IRB shall constitute a diverse
group of voting members. Representation from a broad spectrum of disciplines is
sought. The background and training of IRB members shall include familiarity
with applicable regulations and laws, familiarity with relevant standards of
professional conduct and practice, and knowledge of vulnerable or special
populations.
III. The following criteria apply to each
IRB:
A. The IRB is composed of at least five members with varying backgrounds.
B. The IRB
includes both men and women members, with representation of minority populations.
C. At least one member (the “community representative”) has no
affiliation, other than IRB membership, with the University and is not be an
immediate family member of anyone affiliated with the University.
D. At least one IRB member has professional expertise in a scientific
field relevant to the type of research reviewed by that panel, and at least one
member has primary concerns in a nonscientific field. The IRB panel does not
consist entirely of members of the same profession.
E. The IRB may use independent consultants as necessary to assure
appropriate expertise.
F. Alternate members, if appointed, are designated for a specific member.
IV. By agreement with the William S.
Middleton Memorial VA Hospital, two members of the HS IRB and two members of
the MR IRB must be affiliated with the VA Hospital, have at least a 5/8th
VA Hospital appointment, and be appointed to serve as a VA Hospital representative
to the IRB by the VA Medical Center Director for term of up to three years. At
least one of the VA representatives on each IRB must have scientific expertise.
VA representatives serve as full members of the IRB and review both Department
of Veterans Affairs (VA) research and non-VA research matters coming before the
IRB.
VA Research and Development
administration officials including, but not limited to the Associated Chief of
Staff for Research and Development and the Administrative Officer for Research
and Development, cannot serve as voting members of the IRB.
V. By agreement with the University of
Wisconsin Hospital and Clinics Authority (UWHCA), two members of the HS IRB and
two members of the MR IRB must be representatives of the UWHCA.
VI. The UW-Madison Research Policy Office
reports changes in IRB composition to the federal Office of Human Research
Protections (OHRP).
Procedure
VII. For an IRB meeting to be properly
convened, a quorum must exist. A quorum for IRB meetings is:
A. a simple majority of the IRB’s voting members, and the presence
of at least one member whose primary concerns are in nonscientific areas.
B. for VA research, at least one of the VA representatives on the IRB must
be present.
C. for VA research involving an FDA-regulated article, a licensed physician
must be present.
D. for VA research that involves mentally disabled persons or persons with
impaired decision-making capacity, the presence of at least one member who is
an expert in that area of the research.
VIII. IRB staff monitors the members present
at convened meetings and determines that meetings are appropriately convened
and remain appropriately convened.
IX. If quorum fails during a meeting, the
IRB cannot take further actions or votes until the quorum is restored.
A. An IRB can lose its quorum when members with a conflict of interest
leave the room for deliberation and voting on a research protocol, if there is
no non-scientific member present or when less than a majority of the
IRB’s voting members are present.
B. An IRB member who is unable to be present at the convened meeting may
participate by videoconference or conference telephone call, when the member
has received a copy of the documents that are to be reviewed at the meeting. Such
members may vote and be counted as part of the quorum.
X. When the convened IRB reviews research
involving prisoners (including initial review, continuing review, review of
protocol modifications, and review of unanticipated problems involving risks to
participants or others), the prisoner or prisoner representative must be
present as a voting member.
XI. If both a member and that
member’s designated alternate attend a meeting, only one of the two may
vote. In these cases, the IRB minutes will reflect who is attending as a
voting member.
XII. For research to be approved by the
convened IRB, it must receive the approval of a simple majority of those IRB members
present at the meeting.
