i. Western Institutional Review Board application processings

If a research study goes to Western Institutional Review Board for review, there are some requirements of the University of Iowa prior to submission.  First, the Division of Sponsored Programs must have a copy of the contract and protocol for the project.  Second, if the project requires review by any University of Iowa committees, investigators must have the approvals of the applicable committee prior to Western Institutional Review Board review.  Finally, investigators will need to send all of Western Institutional Review Board submission materials to the University of Iowa Human Subjects Office so that the Western Institutional Review Board coordinator can check for other committee approvals and the required University of Iowa consent language.  At this point, the University of Iowa Human Subjects Office will provide the investigator with an approval memo for submitting new project materials to Western Institutional Review Board for review.  The Human Subjects Office charges a $2000 one-time fee for this administrative review.  The Human Subjects Office website contains a detailed description of the University of Iowa process for submission to Western Institutional Review Board and required forms.

Once the new project has been sent to Western Institutional Review Board for review, Western Institutional Review Board is the IRB of record for the project.  At that point, all investigator correspondence regarding the project will be with Western Institutional Review Board.  In addition, after Western Institutional Review Board approval of the project, the investigator is responsible for submitting all modifications, continuing reviews, serious and/or unexpected adverse experiences, major protocol violations that result in additional risks to subjects, and project closure notice to Western Institutional Review Board using Western Institutional Review Board procedures.  The University of Iowa Human Subjects Office will not coordinate any of these submissions after the approval of the new project by Western Institutional Review Board.  For more information on Western Institutional Review Board procedures, review the Western IRB website.