Human Research Protection Program: Policy
Human Research Protection Program Advisory Committee Charter
Adopted by: Human Research Protection Program
Advisory Committee
Adoption Date: September 7, 2006
Revised: June 7, 2007
Revised: September 13, 2007
Purpose: This
document describes the roles and responsibilities of the UW-Madison Human
Research Protection Program Advisory Committee (Advisory Committee).
Policy
I. Advisory Committee Responsibilities
A. The Advisory Committee is responsible for:
1. advising the UW-Madison Institutional Official on issues relating to
human research protection.
2. oversight of the Human Research Protection Program (HRPP), including
the UW-Madison Institutional Review Boards (IRBs).
3. development and approval of all policies for the HRPP.
4. facilitating communications and exchange of information about human
research protection among the IRBs, between the IRBs and the UW-Madison’s
research community and the UW-Madison community as a whole.
5. communicating directly or through the UW-Madison IRBs with University
institutions, officials, faculty, and staff, as necessary, about regulatory
requirements governing human research protection and interpretations of those
requirements.
6. facilitating access by researchers to cross-disciplinary information
and training about human research protection through the UW-Madison Graduate School.
7. advising the IRBs on issues relating to human research protection.
8. at the request of a UW-Madison IRB, reviewing an IRB decision in a case
of noncompliance, unanticipated problem or suspension or termination of
research
9. advising the Institutional Official regarding the suspension of human
research privileges and reporting to federal authorities in matters involving
noncompliance, unanticipated problems and suspension and termination of
research.
B. The Advisory Committee may review a UW-Madison IRB’s
determination of noncompliance, unanticipated problem or suspension or
termination of research relating to a human research protocol at the request of
an investigator. The Advisory Committee’s review of a UW-Madison
IRB’s decision will be limited to determining whether the UW-Madison IRB
has:
1. followed its own procedures
2. correctly applied federal regulatory criteria or state law, or
3. correctly applied UW-Madison policies.
In the event the Advisory Committee determines that
a UW-Madison IRB has failed to follow its own procedures, has not correctly
applied federal regulatory criteria or state law, or has not correctly applied
UW-Madison policy, the Advisory Committee will return the matter to the
UW-Madison IRB with recommendations for correction or additional review. The
Advisory Committee does not make independent findings of fact when conducting
its review of a UW-Madison IRB’s decision but may request that the
UW-Madison IRB conduct additional fact finding.
If an IRB disapproves a protocol, defers a protocol
application or requires protocol modifications as a condition for approval,
neither the Advisory Committee nor any other UW-Madison official or committee
may overturn the IRB’s decision nor apply undue pressure on the IRB to
reverse a decision or may approve research that has not been approved by an
IRB. However, research that has been approved by an IRB may be subject to
further appropriate review and approval or disapproval by officials of the
institution. 45 CFR 46.112.
A protocol application that has
been reviewed by a UW-Madison IRB may not be resubmitted by the investigator to
another UW-Madison IRB unless the original IRB refers the protocol to the other
IRB. (See, Review by Experts Policy)
II. Selection of Advisory Committee
Members.
A. The Chancellor of the UW-Madison appoints all Advisory Committee
members, who include:
1. the UW-Madison Institutional Official, who serves as chair of the
Advisory Committee.
2. the chair of each of the UW-Madison IRBs.
3. other members at large selected by the Chancellor.
B. The Chancellor may also appoint a representative from outside the UW-Madison
community (a public member).
C. Ex-officio members, non-voting, include:
1. the director of the UW-Madison HRPP.
2. a representative of the UW-Madison’s Office of Administrative
Legal Services.
3. the primary administrators from each of the UW-Madison IRBs.
4. other ex-officio members at large selected by the Chancellor.
D. Alternates for Committee Members. Committee members may designate an
alternate who may exercise all the authority of the committee member at the
meeting for which he or she acts as an alternate. Alternates may include, but
are not limited to, the Director or Manager of the IRB for which the member
serves as chair. To conduct a meeting with alternates present, at least a
simple majority of the required quorum must be committee members who are
faculty or have been granted voting rights by their department.
III. Conflict of Interest for Advisory
Committee Members.
The Advisory Committee
applies the UW-Madison IRB Member Conflict of Interest Policy to Advisory
Committee members and consultants.
IV. Advisory Committee Meetings.
A. The Advisory Committee meets monthly and at the call of its
chairperson.
B. Advisory Committee business is not initiated without a quorum, which is
a simple majority. The Advisory Committee uses Roberts’ Rules of Order
to conduct its business. The Advisory Committee makes decisions about the
matters that come to it through discussion followed by voting.
C. The Advisory Committee makes and keeps minutes for each of its
meetings.
V. University Services to the Advisory Committee.
A. The Research Policy Office in the UW-Madison Graduate School provides
staff support for the Advisory Committee in fulfilling its responsibilities as
listed in Section A.1.a-g, above.
B. The Office of the Secretary of the Faculty conducts annual orientation
seminars for new faculty members that inform them of the purposes and processes
of the Advisory Committee and the four UW-Madison IRBs.
