IRB: Role, Authority, Independence of the IRB
Policy number:
100
References: Board of Regents Policy
http://www1.umn.edu/regents/policies/academic/HumanSubjects.pdf
45 CFR 46.103(b)(2), 45CFR46.109(a), 45CFR46.109(e), 45CFR46.112,
45CFR46.113
21CFR56.101(a), 21CFR56.103, 21 CFR 56.109(a), 21 CFR 56.109(e), 21
CFR 56.112, 21 CFR 56.113
Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
(ICH GCP guidance (E6))
AAHRPP I.1.C
Date: 08/20/14
Policy Owner:
Executive Director, HRPP
Cross Reference:
None
Definitions:
None
1.0 Reason for Policy
Define the purpose of the University of Minnesota Institutional Review Board (IRB), both the institutional
authority under which the IRB operates and the organizational structure for protection of human research
participants.
2.0 Scope of Policy
This policy establishes role, authority, and independence of the IRB to the University community and its
healthcare components, Fairview Health Service and Gillette Children’s Hospital. The Office of the Vice
President for Research (OVPR) is the organizational structure to protect human subjects is a specific matrix of
interconnected departments deployed to achieve a prevailing milieu of ethical oversight, monitoring, and
compliance in the protection of human subjects.
3.0 Policy Statement
The University of Minnesota Human Research Protection Program (HRPP) and the Institutional Review Boards
are under the authority of the Vice President for Research. Authority is derived from the Board of Regents
Policy on Human Subject Protection.
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The organizational structure to protect human subjects is a specific matrix of interconnected departments
deployed to achieve a prevailing milieu of ethical oversight, monitoring, and compliance in the protection of
human subjects. In accordance with federal regulations at 45 CFR 46 and 21 CFR 50 and 56, and other pertinent
regulations, guidance, state and local laws, the University of Minnesota requires all research projects which
meet the regulatory definition of research with human subjects be reviewed and approved by the University of
Minnesota IRBs, prior to initiation of any research-related activities, including recruitment and screening
activities. The IRBs comply with International Conference on Harmonisation Good Clinical Practice E6 (ICH
GCP) guidelines only to the extent that they are compatible with FDA and DHHS regulations and in
circumstances where the PI indicates the sponsor requires following ICH standards.
Process
 Researchers submit plans to protect subjects or request for Exemption from 45CFR 46 to the HRPP for
review. HRPP personnel process applications for review and correspond with researchers regarding the
review process
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All IRBs are independent and do not answer to individuals, departments, or units that rely on the IRB for
the review of their research. The IRBs are the final authority for all decisions regarding the protection
and welfare of humans participating as subjects in research activities. Institutional officials may not
approve the research if it has not been approved by the IRB
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Inappropriate attempts to influence the IRB process, individual IRB members, or HRPP office staff will
be reported to the Institutional Official. The Institutional Official will respond to and stop any attempt at
inappropriate influence and has the authority to limit or remove an investigator’s privilege to conduct
research
Procedures
To carry out its charge of protecting human subjects as required under federal regulations and Regents Policy,
the IRB has the following responsibilities and authorities:
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The IRB reviews and has authority to approve, require modifications of, or disapprove all University
research involving human subjects
Review, approve, modify, disapprove initial, ongoing or continuing proposals to conduct research on
human subjects along with protocols and/or consent documents to ensure compliance with regulatory
and ethical guidelines
The IRB maintains the authority to disapprove studies or requested changes/additions if the standards for
human subjects protection are not met
Continuing Review: All on-going, non-exempt research must be reviewed by the IRB (full committee or
expedited process) in conjunction with additional information and updates provided by the investigator,
at least once per year and as part of this responsibility, the IRB has authority to observe or have a third
party observe the consent process and the research
The IRB has authority to inspect research facilities and obtain records and other relevant information
relating to the use of human subjects in research
The IRB may suspend or terminate approval of an approved study at any time during its oversight of the
research and the investigator and this action may result from unanticipated problems posing risks to
subjects or others, or allegations of, or findings of, serious and/or continuing noncompliance
The IRB reports to appropriate University and federal government officials:
o Any unanticipated problems involving risks to subjects
o Serious or continuing noncompliance with IRB requirements
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o Any suspension or termination of IRB approval of research
The IRB takes such actions that are necessary in its judgment to comply with federal regulations or other
applicable laws, including action to suspend or terminate approval of research that is not being
conducted in accordance with the IRB's requirements or that has been associated with unexpected
serious harm to subjects
In addition to the Board of Regents’ Policy, the IRB secures additional support and authority through
interaction with and support from UMN faculty governance. The following is a statement from the Academic
Freedom and Tenure Committee:
Academic Freedom and the Institutional Review Board
Statement by the Senate Committee on Academic Freedom & Tenure
October 23, 2009
The University of Minnesota's Faculty Senate Committee on Academic Freedom and Tenure advises the
Institutional Review Board (IRB) that it is not an infringement of academic freedom for the IRB to place
restrictions on faculty members who permit or encourage inappropriate research by students using human
subjects. Rather, faculty members who advise students have a responsibility to offer rigorous training and
oversight consistent with IRB expectations when students are conducting research with human subjects.
The Committee takes the position that the safety of the human subjects, and the safety of the students
conducting the research, is paramount, and that the IRB does not infringe academic freedom when it acts to
protect human health and well-being. The Committee is also of the view that the IRB may appropriately
consider the qualifications of the faculty member to supervise the research proposed by the student and may,
without infringing academic freedom, inquire about and ultimately not approve such student research if the
proposed supervision appears inadequate.
Finally, the Committee endorses the proposition that when questions arise, the IRB should work with the
faculty member and the student to ensure that an appropriate research project will be undertaken. Ultimately,
however, the Committee believes that the IRB must make a decision about whether or not it can approve the
project. The faculty member and the student must be notified of their right to appeal the decision.
Adopted unanimously
4.0 Required approvals for this document
Title
Executive Director, HRPP
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5.0 Revision History
Revision
02/16/14
11/09/09
10/01/09
09/26/06
Reason for change
Revision to include administrative changes
Revision to include AF&T statement
Update AAHRPP references
Reformat
Date of release
09/02/14
11/09/09
10/01/09
04/27/09
To obtain a copy of a historical policy, e-mail at IRB@umn.edu or call 612-626-5654
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