University of Wisconsin-La
Crosse
Institutional Review Board
for the Protection of Human Subjects
Operating Guidelines and
Organizational Policies
I.
PURPOSE OF THE
BOARD
A. The UW-La Crosse
Institutional Review Board for the Protection of Human Subjects (IRB) is
responsible for protecting the rights and welfare of human subjects
participating in research projects. The Board exercises its review and approval
functions to ensure the safe, fair, and ethical treatment of persons serving as
research subjects and to ensure that the University and its researchers adhere
to appropriate standards of conduct in their pursuit of knowledge and
understanding.
II.
STATUTORY AUTHORITY OF THE
BOARD
A. Title 45 of the Code of Federal
Regulations, Part 46 (45 CFR 46) implements amendments to the Public Health
Service Act (Public Law 99-158), effective 19 August 1991, that require all
institutions engaged in research involving human subjects to establish an
IRB.
B. The Chancellor, as the
chief executive officer of the University, is responsible for ensuring that the
UW-La Crosse IRB operates in accordance with all applicable laws. The Chancellor
has designated the Provost/Vice Chancellor to monitor the operation of the IRB
and to appoint its membership.
III.
REVIEW POLICIES AND
PROCEDURES
A. The Board shall establish
policies and procedures for the review of research projects involving human
subjects and shall disseminate these broadly and regularly to all appropriate
faculty, staff, and students at the University. The Board shall issue (and
update as needed) a concise brochure that provides An Overview of Policies
and Procedures and a substantive booklet, A Researcher's Guide for
Submission of Protocols to the IRB, that includes required review procedures
and forms. These documents will be available both in print and electronic
formats through the UW-L Office of Sponsored Research, Scholarly and Creative
Activities.
IV.
MEMBERSHIP OF THE
BOARD
A. Federal law requires that
each IRB shall have at least five (5) members who possess sufficient expertise,
experience, and breadth of knowledge to provide complete and adequate review of
research activities commonly conducted at the institution. The IRB membership
must have professional competence necessary to review specific research
activities, as well as knowledge of institutional regulations and commitments,
applicable law, and standards of professional conduct and practice.
B. The law further requires
that each IRB shall include the following types of individuals in its
membership:
1. At least one member of the
Board must have primary professional expertise in scientific areas.
2. At least one other member
of the Board must have primary professional expertise in nonscientific
areas.
3. At least one member of the
Board must not be otherwise affiliated with the institution, including having a
member of the immediate family of a person who is affiliated with the
institution. This member is referred to as the community
representative.
C. The law also instructs that
the Board shall seek to include qualified persons of both genders. The Board may
not consist entirely of members from a single disciplinary
profession.
D. The UW-La Crosse IRB will
consist of not less than ten (10) and not more than fifteen (15) full voting
members who are appointed by the Provost/Vice Chancellor with the concurrence of
the Chancellor.
E. The membership shall
include at least one (1) representative from each of the following units of the
University:
1.
2.
3.
F. To the extent possible, one
voting member of the Board should be a student who will be appointed by the
Provost/Vice Chancellor for one year. The same student may be reappointed for a
successive term.
G. All members of the Board (with the
exception of the community member(s) designated in Section IV.B.3 and IV.F
above) must be members of the faculty and/or academic staff of UW-La
Crosse.
Term of
Appointment:
H. Each voting member of the
Board will serve for a three-year term (with the exception of a student member
in Section IV. F). Appointments to the IRB shall be staggered in rotation, such
that no more than one-third of the Board should be appointed every
year.
I.
The
Provost/Vice Chancellor may reappoint any member for a second term.
J.
Ordinarily, no voting
member, including the community member, may serve for more than six (6)
consecutive years. However, under extenuating circumstances, the Provost/Vice
Chancellor may allow an extension beyond the six
consecutive years.
Permanent and
Ex-Officio Members and Ad Hoc Consultants:
K. The Board shall elect a
Chair from among its faculty membership who will serve as a voting member of the
full board only in the event of a tied decision. The chair shall be elected at
the first meeting of the IRB in the Spring Semester or immediately thereafter.
The elected Chair shall begin her or his term in the first meeting of the
following Fall Semester, and shall serve a one-year term. This individual may be re-elected for a
period commensurate with his or her term of appointment (see above, Items H, I
and J).
L. The Provost/Vice Chancellor
shall appoint an IRB Coordinator for a period of 1-3 years. Ordinarily the IRB Coordinator shall be a
member of faculty and/or academic staff at UW-L who has earned a minimum of a
baccalaureate degree, has a minimum of three years experience as a member of
IRB, and has sound knowledge and understanding of the Federal Guidelines
relating to the Protection of Human Subjects.
M. The Coordinator shall serve as an
ex-officio voting member of the full Board as well as the Executive Committee of
the IRB. The Coordinator shall
review all protocols and approve unless it is determined that the protocol
warrants an in-depth review by the executive committee or the full board. The
Coordinator will work very closely with the elected IRB Chair in making
decisions about a protocol needing in-depth review by the executive committee of
the full board.
N. The Coordinator shall report directly to
the Associate Vice Chancellor for Academic Affairs, who shall serve as a
permanent, nonvoting (ex officio) member and consultant to the Board, and
shall be referred to as the “IRB Administrator.”
O. In accordance with 45 CFR
Section 46.107(f), the Board may, at its discretion, invite individuals with
specialized expertise to participate in its sessions as nonvoting (ad
hoc) consultants.
V.
MEETINGS
The IRB Chair is
responsible for convening the Board according to an established regular schedule
that permits researchers to have their projects reviewed in a timely manner. The
full membership of the Board shall meet at least one (1) time during the
calendar year.
A. A majority of the full
appointed voting membership shall constitute a quorum for the purpose of
holding an official meeting. A majority of those voting members present at an
official meeting shall be sufficient to issue official verdicts, actions, and
judgments.
B. All meetings shall be
conducted in accordance with the state of
VI.
EXECUTIVE COMMITTEE OF THE
BOARD
A. The Provost/Vice Chancellor
with the concurrence of IRB shall appoint an Executive Committee, which will
include the IRB Coordinator and Chair of the Board, to conduct IRB
responsibilities between the regular meetings of the full Board. The Executive
Committee must report its actions to the full Board at the next scheduled
meeting of the IRB, and the minutes of Executive Committee meetings will be sent
in timely fashion to all Board members. The Full IRB Board retains the
authority to review, reverse, modify, or void any decision or action of the
Executive Committee.
B. A principal responsibility
of the Executive Committee is to conduct expedited reviews of projects involving
no more than minimal risk, as specified in 45 CFR Section 46.110. Only
the full IRB has authority to disapprove research activities.
C. The Executive Committee may
consist of not more than two-thirds of the full Board's voting membership and
must include a representative from each of the units designated in Section IV E
above. Executive Committee appointments are for one (1) year but may be renewed
annually within the term limitations outlined in Section IV H, I, and J
above.
D. The Chair of the IRB will
serve as a voting member and Chair of the Executive Committee. The Associate
Vice Chancellor for Academic Affairs will serve as a non-voting member and
consultant to the Executive Committee.
VII.
CONFLICT OF INTEREST
PROCEDURES
A. Any member of the Board who has an
actual or apparent conflict of interest in the initial or continuing review of a
research project may not participate in the Board's deliberations or voting
(except to provide general or specialized information that may be requested by
the IRB).
B. It is the responsibility of the
individual Board member to identify a conflict of interest and remove
him/herself voluntarily by informing the IRB Chair. The specific nature of
the conflict of interest need not be revealed.
C. If someone believes that
there is an actual or apparent conflict of interest in the participation of an
IRB member in a particular case, and that person has not removed him/herself
from the proceedings, a challenge may be raised either by a member(s) of the
Board or by the researcher(s) whose project is under review. A conflict of
interest challenge must be raised prior to the Board's action on the project and
takes immediate precedence as a point of order during an official
meeting.
VIII.
INSTITUTIONAL
REVIEW
A. As provided in 45 CFR
Section 46.112, affirmative decision of the IRB may be subject to further review
by University officials. The Provost/Vice Chancellor and the Chancellor may, at
their discretion, conduct additional, independent inquiry into a decision of the
IRB and may, if their findings so warrant, disapprove a research project
previously authorized by the IRB.
B. In no case may the
Provost/Vice Chancellor or Chancellor approve a research project that the IRB
has previously disapproved.
Operating Guidelines and
Organizational Policies of the UW-La Crosse Institutional Review Board adopted
17 March 1998 and revised 31 January, 2000; 1 September
2004; 1 January 2005; 3 February 2006; 4 August 2006 and 1 May 2007.
Associate Vice
Chancellor
Provost and Vice Chancellor
UW-L Chancellor
for Academic Affairs
for Academic Affairs