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Welcome

The Human Subjects Office (HSO) was established by the Vice President for Research to provide administrative support for the University of Iowa Institutional Review Boards. An Institutional Review Board is a group of individuals charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations. The University of Iowa has three such review boards, each consisting of faculty, staff, and representatives from the Iowa City community.

Mission

The mission of the University of Iowa Institutional Review Boards is to assure that the rights and welfare of human subjects are adequately protected in research.

Upcoming Events

Wed, Feb 10, 2016 -
10:00am to 11:00am

Institutional Conflict of Interest: What it is and how it could impact your research - Location: HP Smith Auditorium, W256 General Hospital, UIHC

Wed, Feb 10, 2016 -
2:00pm to 4:00pm

Spring 2016 - IRB Office Hours - Location: 101 Hardin Library

Thu, Feb 11, 2016 -
10:00am to 12:00pm

Spring 2016 - IRB Office Hours - Location: 101 Hardin Library

Upcoming Meetings

There are currently no meetings scheduled.

Announcements

New review process for IRB-03 studies that involve the Iowa City VAHCS and the University of Iowa.

Attention IRB-03 researchers:  As of February 15th 2016, the IRB 03 board will begin transitioning away from the review of research activity conducted at the University of Iowa.  This means research studies involving both the Iowa City VAHCS and the University of Iowa will have to submit two separate IRB applications, in order for the correct IRB to review the activity at each location.  Going forward, IRB-03 will review research activity that involves the VAHCS only.

Human Subjects Office releases new FDA Site Inspection Guidance

The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations.  The Human Subjects Office (HSO) Compliance Staff has released the newly created FDA Site Inspection Guidance to provide practical advice for Principal Investigators (PI) and research staff undergoing a FDA inspection.

Update to the WIRB submission process

Beginning today (1/15/16) the restriction to retain all industry sponsored trials with an investigational device exemption (IDE) under IRB-01 review has been lifted.  Researchers can submit industry sponsored, industry initiated trials to WIRB.  The existing CMS approval process for IDE's issued by the UIHC Joint Office for Compliance has been incorporated into the HawkIRB submission process for all WIRB & Quorum submissions.