Part 1, Ch. 21 - Appeal of IRB Decision

Investigators may appeal the University of Iowa IRB requirement for specific changes in the protocol and/or consent document(s).  If the application is being reviewed under expedited procedures, the Chair works directly with the investigator to resolve outstanding issues.  Such appeals are documented as responses in the HawkIRB system or via e-mail to the Chair.  If the Chair and investigator cannot resolve the issue(s), the project is referred to full board for review.

If the full board University of Iowa IRB decides to require specific changes or to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision.  An investigator may appeal any of the requested changes or the disapproval.  Such appeals are submitted in writing via HawkIRB as a response to the meeting minutes.  Such appeals must be reviewed at a full board meeting.  If the appeal requires discussion or explanation beyond what can be provided to the board in written format, the investigator may be invited by the Chair to attend the full board meeting at which the appeal is presented.  The board invites the investigator for the purpose of answering questions and participating in discourse with board members.  The investigator leaves prior to University of Iowa IRB discussion and vote on the issues.  In the case of a decision by the University of Iowa IRB to disapprove, suspend, or terminate a project, other parties may not reverse the decision.