IRB: Process for Management of Potential Conflict of Interest
Policy number:
905
References:
AAHRPP I.6.A
AAHRPP I.6.B
AAHRPP III.1.B.
Date: 06/01/2014
Policy Owner:
Executive Director, HRPP
Cross References:
420 Review by Program Components
UMN Regents Policy on Individual Business or Financial Conflict of Interest:
http://regents.umn.edu/sites/default/files/policies/Individual_COI.pdf
UMN Regents Policy on Institutional Conflict of Interest:
http://regents.umn.edu/sites/default/files/policies/Institutional_COI.pdf
http://www.fairview.org/fv/groups/internet/documents/web_content/s_033234.
pdf
http://www.gillettechildrens.org/uploads/general/Forms/Rights_and_Responsi
bilities_in_Research.pdf
Definitions:
None
1.0 Reason for Policy
Describe the process followed to identify and manage financial and non-financial relationships and
possible conflicts of interest (COI) that might arise in studies proposed to the IRB.
2.0 Scope of Policy
This policy applies to the University-wide research community and its healthcare components.
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3.0 Policy Statement
University of Minnesota researchers and personnel working with human subjects will follow University
of Minnesota policies and procedures for reporting and management of potential conflicts of interest.
Fairview and Gillette researchers and personnel working with human subjects will follow their
respective institutional policies and procedures for reporting and management of potential conflicts of
interest. In every instance of human subject research, the IRB will make the ultimate determination
whether a conflict of interest has been managed to protect the participants in the research.
Potential Individual Conflicts Reported from IRB to OIC for University of Minnesota Applicants
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Researchers will complete the IRB application forms addressing the conflict of interest
questions.
In every case where the researcher indicates that there may be a potential conflict of interest
meeting the University definitions, the application will be held from IRB review and referred for
review by the Conflict of Interest (COI) Program.
If the COI program staff finds no potential for conflict of interest, or determines that a current
conflict management plan is already in place, the COI program will communicate this
information to HRPP via an email (referencing the IRB study number) to irb@umn.edu. The IRB
Executive Director and HRPP staff who initiated the request, if applicable, will be copied on the
email.
If the COI Program staff believes the researcher may have a conflict of interest, the matter will
be referred to a Conflict Review Panel (CRP).
If the CRP finds that the researcher has a conflict of interest, it will determine whether the
researcher can participate in the project under the terms of a conflict management plan (CMP).
The COI Program will provide the CMP, via email, to irb@umn.edu (referencing the IRB study
number) with a cc: to the Executive Director. The CMP will be provided to the IRB for review.
Based on the regulatory status of the study, the convened IRB or the designated Expedited
Reviewer will make the ultimate determination of whether a conflict of interest has been
managed to protect the participants in the research..
Potential Individual Conflicts Reported from OIC to IRB for University of Minnesota applicants
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For existing studies on which a CRP has determined a conflict of interest is now present, the
conflict management plan will be sent to HRPP by OIC staff via an email to irb@umn.edu
(referencing the IRB study number).
Senior HRPP staff will first ascertain the regulatory status of the study.
 For studies that are in data analysis or are retrospective chart reviews for which consent
and HIPAA obligations have been waived by the IRB at initial review, an expedited
review of the conflict management plan will be conducted.
 Management plans on studies currently enrolling and/or following subjects typically will
be reviewed by the convened IRB.
Potential Individual Conflict on Submissions to the IRB from Fairview or Gillette Applicants
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Researchers will complete the IRB application forms addressing the conflict of interest
questions.
In every case where the researcher indicates that there may be a potential conflict of interest
meeting Fairview or Gillette definitions, the application will be held from IRB review and
referred to the healthcare component institution for review.
If the healthcare component COI program staff finds no potential for conflict of interest, or
determines that a current conflict management plan is already in place, the COI program will
communicate this information to HRPP via an email (referencing the IRB study number) to
irb@umn.edu. The IRB Executive Director and HRPP staff who initiated the request, if
applicable, will be cc:d on the email.
If the healthcare component COI Program staff believes the researcher may have a conflict of
interest, the matter will be referred for review by healthcare component institution staff.
If the healthcare component COI Program finds that the researcher has a conflict of interest, it
will determine whether the researcher can participate in the project under the terms of a conflict
management plan (CMP).
The COI Program will provide the CMP, via email, to irb@umn.edu (referencing the IRB study
number) with a cc: to the Executive Director. The CMP will be provided to the IRB for review.
Based on the regulatory status of the study, the convened IRB or the designated Expedited
Reviewer will make the ultimate determination of whether a conflict of interest has been
managed to protect the participants in the research.
Potential University of Minnesota Institutional Conflict on Submissions to the IRB and Existing
Research Approved by the IRB
The process used for potential individual conflicts is also used for potential Institutional Conflicts of
Interest concerning human subject research in which the University has a financial interest. If a potential
conflict of interest exists, the COI Program will refer the matter to the Institutional Conflict Review
Panel (ICRP).
If the ICRP finds a conflict of interest and approves a conflict management plan, the CMP is sent via
email to irb@umn.edu (referencing the IRB study number) with a copy to the Executive Director. The
IRB will review and make a final determination of whether the research can be approved based on the
plan.
In every instance of human subject research where a potential institutional conflict is identified, the
convened IRB will make the ultimate determination of whether a conflict of interest has been managed
to protect the participants in the research.
4.0 Required approvals for this document
Title
Executive Director, HRPP
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5.0 Revision History
Revision
Reason for change
Date of release
06/01/14
05/07/12
03/09/12
02/05/10
11/02/09
10/05/09
08/24/09
05/15/07
Reformat and update links
Additional clarity on route
Revision clarify route of review
Revision
Update AAHRPP references
Revisions
Reformat, Revisions
Policy Development
09/02/14
05/07/12
03/09/12
02/05/10
11/02/09
10/05/09
To obtain a copy of a historical policy, e-mail the IRB at irb@umn.edu or call 612-626-5654.
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