Modifying an Approved IRB Application or Materials

Any change in study procedures or personnel must be submitted and approved by the IRB before being implemented.  A modification application is the vehicle to make those changes.  By starting a modification, your currently approved IRB application is opened up for editing, allowing you to alter, delete, or add to anything in your application and/or attachments.  Exceptions to the process can only be made when there are concerns for subject safety.  If there are subject safety concerns, contact an IRB Chair immediately.

Please see the Modifications page for more information.

Reportable events

During the course of a research study, events or problems may occur that investigators neither expect nor anticipate. Investigators may not even be aware that certain events need to be reported to the IRB. Reportable events are not defined in the federal regulations, but the University of Iowa requires investigators to report incidents in which the regulations, IRB policies, and the IRB determinations related to the protection of human subjects were not followed, when unanticipated or unexpected problems occur, or when serious adverse events occur. 

Please see the Reportable Events page for more information.

Continuing Reviews

Except for studies determined to be exempt from IRB oversight, all human subjects studies are subject to continuing review.  The IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year [45 CFR 46.109(e) (DHHS) and 21 CFR 56.109(f) (FDA)]. This is called "continuing review." The continuing review for these studies is required to occur as long as the research remains active for long-term follow-up of the research subject, even when the research is permanently closed to the enrollment of new subjects and all subjects have completed all research-related interventions, as well as when the remaining research activities are limited to collection of private identifiable information.   The IRB, IRB Chair, or Chair Designee reviews the continuing review application submission form as well as the research project and applicable attachments in its entirety.  

No further research related activity can occur on or after the date that the project expires. After approximately 24 hours, your project will be closed by the IRB. To be able to conduct this research again, you would need to submit a New Project Form and await IRB approval.

If suspending research activity may endanger subjects, please contact an IRB Chair immediately.  Continuation of research related interventions or interactions with already enrolled subjects is allowed only when the IRB or IRB Chair determines that it is in the best interest of individual subjects to do so.  For VA studies, this determination is made only in consultation with the VA Chief of Staff. The IRB notifies the sponsor of any VA studies for which the IRB does not grant continuing review.

Please see the Continuing Review page for more information.

Project closure

A Project Closure Form notifies the IRB that all human subjects research has ended, and IRB approval is no longer needed. When a study ends, is closed, or canceled for any reason, the Principal Investigator (PI) or their HawkIRB delegate must submit a Project Closure Form. Before the PI leaves the University of Iowa, they should submit a Project Closure Form or a Modification form to change the PI (if research activities will continue at the UI). 

Please see the Study Closure page for more information.