- Whom do I contact?
The Human Subjects Office (HSO) is the administrative support office for the University of Iowa Institutional Review Boards (IRB) and the UI Human Research Protection Program (HRPP)..
HSO/IRB Overview and Educational Resource
If your research project meets the regulatory definition of human subjects research, you are required to obtain approval from the Institutional Review Board (IRB.)
To determine if your study meets this definition, review the Human Subjects Research Determination Guide. To receive a formal determination from an IRB Chair, submit a Human Subjects Research Determination form (HSRD) using the eReseach (HawkIRB) application.
View the Human Subjects Office/Institutional Review Board Overview and Educational Resources. Learn about the UI eResearch -IRB application and review system, called HawkIRB. Read about the HawkIRB Delegate Permission System.-
Complete and submit a New project application via HawkIRB to initiate the IRB review process. The Human Subjects Office offers recorded HawkIRB trainings in the IRB ICON Course for Researchers.
Review the Other Committee Tool and information about additional Human Research Protection Program (HRPP) Committees that may need to review your IRB application.
Visit the Education and Training page of the Human Subjects Office website for additional information about training and educational resources.
All investigators proposing to conduct human subjects research at the University of Iowa or at the Iowa City VA Health Care System (VAHCS) are required to complete human subjects protection training in the CITI Program. For UI researchers this is a one-time training requirement. There are other trainings available in the CITI program, such as refresher course, Good Clinical Practice and Responsible Conduct of Research.
Follow the instructions in the CITI Program page of the HSO website:
- Researchers who have not completed this training at a previous institution, follow the instructions in #9.
- Researchers who completed this training at a previous institution, follow the instructions in #14 to affiliate with the UI IRB.
Your application will be reviewed by administrative support staff prior to being sent to the IRB Chair or the convened board for final review and approval. During the IRB review process, forms may be routed back through HawkIRB workflow with questions or requests for clarification. You will receive an email when the form is routed back. The IRB review process will resume when you route the form back to the IRB through workflow.
Review process: Your application will be assigned to one of four Institutional Review Boards, depending on the type of study.
-Behavioral/Social Science (IRB-02)
-Western Institutional Review (WIRB) (industry initiated and industry sponsored studies)
Depending on the risks posed to potential subjects, your projects will be reviewed by one of the three methods:
-Full Board Review
Detailed information about the review process can be found in Section II of the Investigator’s Guide. An example of what you can expect for application processing can be found in the HSO/IRB Process Flowchart
Review information about processing times for IRB review by quarter, IRB, review type and form type.
Investigators have a variety of IRB communication and record-keeping responsibilities after the research project is initiated. Major responsibilities are described in the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 19-24.
Modifications: Any change in the conduct of a study must be reviewed and approved by the IRB prior to implementing the change (unless there is an apparent, immediate hazard to subjects).
Continuing Review: The IRB is required to review and approve all research projects that are more than minimal risk at intervals appropriate to the degree of risk to subjects, but not less than once a year
Various Reporting Requirements: Researchers are required to report to the appropriate UI IRB any of the following events:
- Serious Adverse Drug Events
- Serious Adverse Device Effects
- Unanticipated Problems Involving Risk to Subjects or Others
- Incidents of Noncompliance
See the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 19.B (Reportable Events).
Other UI Committees Reviewing Human Subjects Research: The UI IRB coordinates reviews with other institutional committees that are part of the UI Human Research Protection Program (HRPP).
Research investigators who conduct studies that involve clinical services at UI Health Care* must participate in required research billing compliance processes and procedures. The procedures streamline and centralize the research billing process, and address the risks associated with inappropriate billing to Medicare and other third party payers.
For more information, go to the Research Billing Compliance page on The Point.
The Point is the intranet site for UI Health Care employees, and a password may be required. If you are not a UI Health Care employee and need access to the Research Billing Compliance page on The Point, please send an email to email@example.com, or call 4-9688.
* University of Iowa UI Community Medical Services, Inc. clinics, UI Clinical Outreach Services clinics, Child Health Specialty clinics, and Student Health
The UI Health Care Record of Consent policy requires documentation of study participation in the UIHC medical record for research that involves physical intervention (e.g., cheek swab, blood draw, investigational drug, etc.) or specimen collection. Read more in the Record of Consent FAQ and in the UIHC policy (IM-MR-6.21) on The Point.
Yes. All human subjects research projects are subject to review at any time. Detailed information about what to expect related to IRB compliance monitoring is available in the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 11.E (Compliance Monitoring).
First, determine whether you should close your study and read the instructions for how to submit a Project Closure form. Once a human subjects project is closed, no future research related activity can occur.
Submit the Project Close form via Hawk IRB.
10. Links to relevant policies, procedures, and resources, etc.
Education & Training Resources
IRB ICON Course for Researchers
eResearch Application System (HawkIRB)
Research Navigation Tool for New Faculty/Research Scientists
Research Subject Compensation Policies and Procedures