Jump to section:

  1. Whom do I contact?
  2. How do I know if I need to obtain IRB approval?
  3. How do I get started if my research does require IRB approval?  What are the recommended steps?
  4. What are the training obligations?  Are educational resources available?
  5. What should I expect after I submit?
  6. What are my responsibilities related to Human Subjects Research Compliance?
  7. What if I am using UI Health Care clinical services in my human subjects research?
  8. Will the IRB monitor my project after my approval?
  9. How do I close a research study?
  10. What other human subjects resources should I know about?

1.  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). 

Contact Information

319-335-6564  
Staff Directory 
irb@uiowa.edu  
Human Subjects Office website 

2.  How do I know if I need to obtain IRB approval?

If your research project meets the regulatory definition of human subjects research, you must obtain approval from the Institutional Review Board (IRB).  

To receive a formal determination from an IRB Chair, submit a Human Subjects Research Determination (HSRD) form in the HawkIRB system.   

For additional information, see: Do I need IRB Review? Is this Human Subjects Research? A Guide for Investigators. 

3.  What resources will help me get started if my research requires IRB approval?  

The UI IRB Standard Operating Procedures and Researcher Guide includes information about UI IRB policies and procedures. 

Additional educational resources include:  

To learn how to navigate in the system and prepare forms for submission, watch the recorded HawkIRB trainings in the IRB ICON Course for Researchers. This ICON course is available to anyone with a HawkID.  

For guidance on each type of HawkIRB form, see Submit to IRB. 

Visit the Get Help page of the Human Subjects Office website for additional training and educational resources. 

4.  What are the training requirements? 

All principal investigators proposing to conduct human subjects research at the university, the Iowa City Veterans Affairs Health Care System (VAHCS), and their research team members must complete human subjects protection training in the Collaborative Institutional Training Initiative (CITI) Program.  

For UI researchers, this is a one-time training requirement. Follow the instructions in the UI CITI Program Users Guide (under Training Requirements) to ensure completion of the required training and proper UI affiliation if you completed CITI training at another institution. 

Additional CITI trainings are available as needed, such as refresher courses, Good Clinical Practice (GCP), and Responsible Conduct of Research (RCR). 

5.  What should I expect after I submit?

Administrative support staff will review your application before it is sent to an IRB chair or the convened board. During the review process, forms may be returned through HawkIRB workflow with questions or requests for clarification. You will receive an email when action is required. The IRB review process will resume when you return the form to the IRB through workflow. 

Review process 

In Section I.1 of the HawkIRB New Project form you may select one of the local IRBs: 

  • Biomedical (IRB-01) 

  • Behavioral/Social Science (IRB-02) 

  • VA Health Care System (IRB-03)  

You may also select a commercial or external IRB. See the Human Subjects Office website for guidance about relying on another IRB or using the single IRB model with the UI as the lead IRB. 
Depending on the risks to subjects, your projects will be subject to one of the three types of IRB review: 

  1. Full board review (more than minimal risk) 

  1. Expedited review (minimal risk) 

  1. Exempt review (fits into one of six categories, see the Exemption Tool) 

 See a flow chart of the human subjects research review process.  

Detailed information about the review process can be found in the UI IRB Standard Operating Procedures and Researcher Guide.  

  • See the Metrics page of the Human Subjects Office website for median processing times by IRB, review type, and form type. 

6.  What are my responsibilities related to human subjects research compliance?

Principal 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.  

Oversight 

Principal investigators, department executive officers (DEOs), and faculty advisors of student principal investigators make agreements with the IRB about oversight and conduct of the research. The principal investigator is responsible for the quality and accuracy of HawkIRB submissions, training and supervision of research team members, ensuring the conduct of the study as approved by the IRB, and compliance with IRB and institutional policies and procedures.  

Modifications 

Unless an immediate hazard to subjects is identified, the IRB must review and approve any change in the conduct of a study before the research team can implement the change. 

Continuing review 

The IRB must 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. 

Reporting requirements 

Researchers must report the following events to the appropriate UI IRB: 

  • Serious adverse drug events 

  • Serious adverse device effects 

  • Unanticipated problems involving risk to subjects or others 

  • New information 

  • Incidents of noncompliance 

See the Reportable Events page of the Human Subjects Office website and the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 19.B (Reportable Events). 

Other UI Committees Reviewing Human Subjects Research 

As needed, the principal investigator must communicate directly and obtain approval from other institutional committees within the UI Human Research Protection Program. Many of these committees review information in HawkIRB but may require separate applications or processes.  

7. What if I am using UI Health Care clinical services in my human subjects research?

Researchers who conduct studies that involve clinical services at UI Health Care* must follow required research billing compliance processes and procedures. The procedures streamline and centralize billing 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. 

* Includes University of Iowa 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 medical record for research involving 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 Loop. 

8.  Will the IRB monitor my project after my approval?

All human subjects research projects may be reviewed at any time. See detailed information about IRB Compliance Monitoring on the Human Subjects Office website and in the UI IRB Standard Operating Procedures and Researcher Guide, Section II, Part 11.E (Compliance Monitoring).  

9.  How do I close a HawkIRB application?

Determine whether you should close your study and review the instructions for submitting a Project Closure form. Once a project is closed, no research-related activity can occur. 

Submit the Project Close form via HawkIRB.

10. What other human subjects resources should I know about? 

  • Education and training resources: The HSO and IRB offer many training and educational opportunities for principal investigators, student researchers, HawkIRB delegates, research team members, faculty advisors, and instructors. 

  • Educational tools: The HSO provides tools and documents to support best practices for study procedures and compliance. 

  • Training Requirements: The UI IRB requires basic training in human subjects protection through the CITI Program for all UI researchers conducting human subjects research. Follow the step-by-step instructions in the UI CITI Program Users Guide to ensure completion of the correct course. 

  • HawkIRB (eResearch Application System): HawkIRB is a confidential, fully integrated, web-based system for human subject researchers, the IRB, and the HRPPs.