Disagreement
with Committee Decisons?
Disagreements with IRB Decisions
The Research Subjects’ Protection Program leadership recognizes
that actions of the committee are subject to scrutiny by the research
community. The Institutional Review Board evaluates a wide range
of research, and RSPP wants researchers to know there is an avenue
to address disagreements regarding committee decisions.
Principal investigators wishing to raise concerns with IRB decisions
should first clarify their understanding of the recommendations
or requirements with RSPP staff (612-626-5654 or
irb@umn.edu). It is also recommended that researchers familiarize
themselves with the specific regulation requirements related to
the committee concerns. These references can most often be found
on the IRB website.
How do I submit documents for
review
If researchers are unable to address concerns through these traditional
methods, then a researcher may address controverted issues by meeting
with the committee. Before meeting with the committee, researchers
should describe their concern and forward any supporting materials
to RSPP. The submission should be a scientifically based position
outlining the specific concerns, provide references, scientific
rationale, and/or supporting material.
The submission will be referred to the committee for discussion.
The process may include meeting with the committee at its next meeting
if requested and appropriate. The process will include communication
with all the relevant parties to collect additional information
as well as the transmittal of the findings, recommendations and
resultant actions back to the researcher.
Is there anything else I should know
All communication concerning IRB submissions should be submitted
directly to the RSPP office, and not to individual committee members
or to other University of Minnesota officials. Per federal regulations,
45 CFR 46.112 and 21 CFR 56.112, officials may not approve the research
if it has not been approved by an IRB. These regulations prevent
University of Minnesota officials such as the RSPP Director, the
Institutional Official, and the Vice President of Research from
overruling a decision by the IRB.
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