3c. Working with human subjects in research

  1. Whom do I contact?

1.  Whom do I contact?

The Human Subjects Office (HSO) is the administrative support office for the University of Iowa Institutional Review Boards (IRB).  

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

The IRB also holds walk-in office hours to answer questions about conducting human subjects research.

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.)

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 HawkIRB system.  

3.  How do I get started if my research does require IRB approval?  What are the recommended steps?

  1. Learn about the UI’s web based IRB application and review system called HawkIRB.  
  2. Complete and submit a new project application submission via HawkIRB for the IRB to conduct their review. 
  3. Review the list of additional Human Research Protection Committees that may need to review your application on the HSO website.  

4.  What are the training obligations?  Are educational resources available?

All investigators proposing to conduct human subjects research at the University of Iowa or at the Iowa City VAMC are required to complete an education program and become “certified” in human subject protections. 

Additional training and educational resources include:

5.  What should I expect after I submit?

  1. Your application will be reviewed by the Administrative support staff prior to being sent to the IRB Chair or IRB convened board for final review and approval.  
  2. If the IRB has questions regarding the HawkIRB application submission, you will be contacted via workflow (email).
  3. Review process: Your application will be assigned to one of four Institutional Review Boards, depending on the type of study.
    -Biomedical (IRB-01)
    -Behavioral/Social Science (IRB-02)
    -VAMC (IRB-03)
    -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
    -Expedited Review
    -Exempt Review

    Detailed information about the review process can be found in Chapters 4 and 7 of the Guide for Human Subjects Research.

  4. How long will the process take? Review the HSO’s information on average processing times for IRB review.

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 Chapter 7 of the Investigator’s Guide.  

  1. Modifications: Any change in the conduct of a study must be reviewed and approved by the IRB prior to implementing the change.
  2. 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
  3. Various Reporting Requirements
  4. Other University Committees Reviewing Human Subjects Research: The University of Iowa Institutional Review Boards coordinate reviews with other institutional committees as described on the Human Subjects Office website. 

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, contact the Joint Office for Compliance:

Denise Krutzfeldt
Associate Director
384-9688, mailto:denise-krutzfeldt@uiowa.edu

Or 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 an employee of UI Health Care and need access to the Research Billing Compliance page on The Point for your studies, please send an email to mailto:researchbilling@healthcare.uiowa.edu, or call 4-9688. 

* includes all UI Community Medical Services, Inc. clinics, UI Clinical Outreach Services clinics, Child Health Specialty clinics, and Student Health

8.  Will I be monitored after my approval?

Yes.   All human subjects research projects are subject to review at any time. Detailed information about what to expect related to monitoring is available beginning on Ch. 7, Section D of the Guide for Human Subjects Research

9.  How do I close the application?

  1. First, determine when 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.
  2. Submit the form via Hawk IRB.

10. Volunteer recruitment 

ResearchMatch.org aims to serve as an effective, useful and complementary recruitment tool for Principal Investigators to search for appropriate volunteers to be placed in their research studies (not just clinical trials).  Supported by the NIH, Researchmatch.org matches willing volunteers not only from Iowa but from a nationwide database if needed.  

The University of Iowa Center on Aging manages the STAR Registry, a database  of Iowans over age 50 who are interested in volunteering for research studies at the University of Iowa (UI), and live within a two-hour driving radius of the university.

The Preventive Intervention Center manages the Clinical Research Volunteer Registry of individuals who have an interest in participating in research studies conducted by researchers at PIC.

Research Subject Compensation Policies and Procedures

10.  Relevant policies, procedures, links, etc.