IRB: Role of the Institutional Official
Policy number:
101 A
References:
45 CFR 46.103 (c)
Board of Regents Policy:
"Research Involving Human Subjects".
http://www1.umn.edu/regents/policies/academic/HumanSubjects.pdf
AAHRPP I.1.B
AAHRPP II.2.D, II.2.E
Date: 02/16/14
Policy Owner:
Executive Director, HRPP
Cross References:
409 Reporting Requirements
410 Suspension and Termination
411 Unanticipated Problems
Definitions:
”Institutional Official” is synonymous with “Signatory Official” and
“Organizational Official”
1.0 Reason for Policy
To identify the official at the University of Minnesota charged with the overall responsibility for the
Human Research Protection Program (HRPP). To delineate the role and responsibility of the
Institutional Official (IO).
2.0 Scope of Policy
This policy is University-wide. All components of the University of Minnesota system conducting
human subject research serve under the IO.
3.0 Policy Statement
The President of the University of Minnesota appoints a delegate with sufficient standing, authority, and
independence to carry out the functions of the IO.
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The Institutional Official is the signatory official on the Federal Wide Assurance with the Office for
Human Research Protection and on all authorization agreements, inter-institutional agreements
describing IRB review authorities and Department of Defense addenda.
The IO has the authority to review decisions of the IRB. In the case of an approval decision, if the IO
determines that a project does not fully comply with policies or obligations of the University of
Minnesota, the IO may disapprove, suspend, or terminate the project on behalf of the Institution. In the
case of a decision by the IRB to disapprove, suspend, or terminate a project, the decision may not be
reversed by any other person or entity including the IO or any other institutional officer
As delegated by the President, the IO duties include, but are not limited to:
 Ensuring compliance with ethical standards, laws, regulatory requirements, institutional
policies, and standards of excellence established for each component within the
integrated compliance system
 Ensuring that there are acceptable resources available for the IRBs and administrative
staff to function effectively and efficiently
 Responsibility for reporting to federal regulatory authorities, other institutional officials,
and funding agencies, as applicable, for routine required reports and report of
unanticipated problems or non-compliance reporting
 Responsibility for appointing and evaluating committee members and chairs;
 Overseeing the administrative functions provided by the Human Research Protection
Program (HRPP)
 Ensuring that legal counsel is available to the HRPP
 Maintaining external accreditation of the program at the discretion of the President
 Ensuring appropriate oversight while maintaining the autonomous functions of the
committees
 Ensure that the HRPP, and the composition and membership of the IRBs is evaluated no
less than annually.
The IO may authorize experienced members of the HRPP staff to act as his/her designee on specific
issues, but may not delegate institutional authority for the IO role.
4.0 Required approvals for this document
Title
Institutional Official, Vice President for Research
Executive Director, HRPP
5.0 Revision History
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Revision
02/16/14
01/27/10
10/01/09
04/06/09
Reason for change
Update
Update and cross reference
Update AAHRPP reference
Revise and Reformat
Date of release
09/02/14
01/27/10
10/01/09
04/06/09
To obtain a copy of a historical policy, e-mail irb@umn.edu or call 612-626-5654
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