Clinical Trial Approval Process
All human subjects
research carried out at The University of Iowa
or under its auspices must be
reviewed by the Institutional
Review Board (IRB). Projects that have industry-sponsored
external support must also be reviewed and approved
by the Clinical Trials Office and the Human Subjects Office.
The Clinical Trials
Office processes pre-clinical and clinical studies
that involve evaluation
of a technology or product. All clinical trials
involving funds from an
industry must include an indirect cost.
Please contact the
Office of Clinical Research
(319-335-6763) to
discuss the current
indirect cost rate.
The Human Subjects
Office provides administrative support for
the IRB process by
reviewing and approving all research projects
involving human
participants, regardless of funding,
prior to
initiation of the research. This includes the IRB application
as well as
the Informed Consent Document.
Reviews on average
take
approximately 5 - 8
weeks
The following chart
shows the flow of the clinical trial
approval process:
