Institutional Review Boards (IRBs)

There are three IRBs at the University of Iowa.  All IRBs review and approve research in accordance with Department of Health and Human Services (DHHS) regulations at 45 CFR 46. In addition, for studies involving products regulated by the Food and Drug Administration (FDA), IRB-01 and IRB-03 comply with the requirements set forth in 21 CFR 11, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 21 CFR 814, Subpart H.  IRB-03 also reviews and approves research in compliance with Department of Veteran Affairs, Veterans Health Administration Handbook 1200.05

Specific Human Subjects Protections certification requirements (CITI) are required for each of the three IRBs.  To review IRB specific training requirements, please see the Certifications in Human Subjects Protections (CITI) page of the HSO Website found here

IRB Review of Applicati​ons

Application materials are pre-reviewed by the Human Subjects Office staff for completeness and are then forwarded to the appropriate IRB chair or their designee for review of studies that are no more than minimal risk.  The IRB chair or their designee determines whether a protocol is eligible for expedited review or is exempt from the regulations.   Most minimal risk studies can be classified as expedited or exempt.  If the study can be classified as expedited or exempt, the chair communicates directly with the Principal Investigator, generally via HawkIRB, regarding any issues or revisions that are required prior to approval.  Notice of approval is sent to the Principal Investigator via HawkIRB.

Applications requiring full board review (those that are greater than minimal risk) are placed on the agenda of the next available full board meeting.  The Human Subjects Office will make a concerted effort to provide all scheduled IRB meetings with membership from every expertise to provide a complete review of projects.  However, the Human Subjects Office reserves the right to move a project to another scheduled meeting if a board member with that particular expertise is not available to provide a complete review of the application.  Application materials are distributed to IRB members at least 7-10 days prior to any scheduled IRB Full Board meeting.  This lead time gives members a chance to review the materials and to develop their review recommendations.  The Principal Investigator is notified of the results of the meeting via HawkIRB or e-mail.  After the Principal Investigator responds to the issues or revisions required by the full board, he or she is notified of approval via HawkIRB.

The IRB review process is captured on this flowchart.  For a complete description of IRB procedures, please refer to the Guide for Human Subjects Research or the UI IRB SOP.

IRB-01 Bi​omedical**

Research projects involving human participants are reviewed by IRB-01 if:

  • the Principal Investigator is from the College of Dentistry, Medicine, Pharmacy, or the Department of Speech Pathology and Audiology in the College of Liberal Arts, College of Public Health OR
  • the Principal Investigator is from the College of Nursing AND the study involves a physical or physiological intervention that is greater than minimal risk OR
  • the study involves patients at the University of Iowa Health Care (UIHC) OR
  • the study involves access to or creation of any protected health information about the subject that is maintained in UIHC health care provider's records.

Click here for more IRB-01 information including:

  • the full board meeting schedule,
  • the expedited review timeframe,
  • rosters of current and past IRB-01 members,
  • names and contact information for the IRB-01 chairs

IRB-02 Behavio​ral/Social Science**

Any research project involving human participants, regardless of funding, is reviewed by IRB-02 if:

  • the Principal Investigator (PI) is from College of Business, Education, Engineering, Law, Liberal Arts (except for those from the Department of Speech Pathology and Audiology), College of Nursing, or College of Public Health*.
    * the College of Public Health can elect to submit under IRB-02 if none of the below conditions apply.  

HOWEVER, even if the PI is from one of the above colleges, IRB-01 would review the project if:

  • the PI is from College of Nursing and the study involves a physical intervention that is greater than minimal risk, OR
  • the study involves University of Iowa patients (including dental patients and student health) or VAMC patients, OR
  • the study involves access to, creation, or use of any health information about the subject that is maintained in a health care provider's records.

Click here for more IRB-02 information including:

  • the full board meeting schedule,
  • the expedited review timeframe,
  • rosters of current and past IRB-02 members,
  • names and contact information for the IRB-02 chairs

IRB-03 ​VAHCS**

Research projects involving patients or their data, resources, staff, or on VA premises are reviewed by IRB-03.

Click here for more IRB-03  information including:

  • the full board meeting schedule,
  • the expedited review timeframe,
  • rosters of current IRB-03 members,
  • names and contact information for the IRB-03 chairs

**For any project submission to the University of Iowa IRB, the IRB Chair(s) will have the final decision in determining which IRB is appropriate to review a submission based on the content of the research application.  (e.g. need for medical expertise or social\behavioral science review)