2c. Working with human subjects in research

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).

Phone: (319) 335-6564, Staff Directory
Email: irb@uiowa.edu
Website: http://hso.research.uiowa.edu/

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 are required to obtain approval from the Institutional Review Board (IRB). See Do I need IRB Review? Is this Human Subjects Research? A Guide for Investigators.

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

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

For information about UI IRB policies and procedures, see the UI IRB Standard Operating Procedures and Researcher Guide. Additional guidance documents are available on the Guides and Standard Operating Procedures (SOPs) page of the Human Subjects Office website.

View the Human Subjects Office/Institutional Review Board Overview and Educational Resources. Learn about the UI eResearch (HawkIRB) application and review system. Read about the HawkIRB Delegate Permission System.

View recorded HawkIRB trainings in the IRB ICON Course for Researchers to learn how to navigate in the system and prepare forms for submission. This ICON course is available to anyone with a HawkID. See guidance about each type of HawkIRB form under Submit to IRB.

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

4. What are the training requirements?

All investigators proposing to conduct human subjects research at the University of Iowa (UI) or at the Iowa City VA Health Care System (VAHCS), and their research team members, are required to complete human subjects protection training in the 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 to affiliate with the UI if you completed CITI training at a previous institution.

There are other trainings available in the CITI program, as needed, such as refresher courses, Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR).

5. What should I expect after I submit?

Your application will be reviewed by administrative support staff prior to review by an IRB Chair or the convened board. 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: 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)

Or you may 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 posed to potential subjects, your projects will be reviewed by one of the three Types of IRB Review:

Full Board Review (more than minimal risk)
Expedited Review (minimal risk)
Exempt Review (fits into one of six categories, see the Exemption Tool)

Detailed information about the review process can be found in the UI IRB Standard Operating Procedures and Researcher Guide. Review the Other Committee Tool and information about additional Human Research Protection Program (HRPP) Committees that may need to review your IRB application. This flowchart provides an overview of the human subjects research review process.

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

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

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: Investigators, Department Executive Officers, and Faculty Advisors of student Principal Investigators make agreements/assurances with the IRB about oversight and conduct of the research. The 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: 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

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
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 necessary, the investigator must communicate directly and obtain approval from other institutional committees that are part of the UI Human Research Protection Program (HRPP). Many of these committees review information in HawkIRB, but they may also have a separate application form/process.

7. What if I am using UIHC clinical services in my human subjects research?

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 researchbilling@healthcare.uiowa.edu, or call 319-384-9688.

* 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.

8. Will I be monitored after my approval?

All human subjects research projects may be subject to review at any time. View 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?

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 HawkIRB.