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) will need to be assigned to a full board meeting. There are two processes that HSO will use to assign a study to a meeting: 

• Identifying an IRB Meeting Goal:  This is a new process that is part of the 2024 IRB Efficiency Initiative.  This process focuses on new study submissions only (Continuing Reviews and Modifications are not eligible).  Within a few days after the project has past the initial prescreen stage, HSO Staff will reserve a spot on a future meeting date (referred to as the goal date).  HSO Staff will consider which meeting has appropriate space, expertise, quorum, completeness of application, and overall institutional goals for IRB approval.  The PI and all HRPP committees will be communicated the proposed date of the meeting.  The PI, HRPP committees and HSO Staff will need to work in unison to ensure all issues are addressed up to 12 days before the proposed meeting date so the study can be finalized for meeting preparation.   
  • If the study has outstanding issues and is not ready for IRB review, the IRB meeting  date is reassigned to a later meeting.  HSO Staff will use the conventional process to assign to a later date once the study is ready (see below). 
• Conventional Process:  This process is used for Modifications, Continuing Reviews and new studies that were not ready for IRB review by the reserved IRB meeting date.  Once the form has completed HSO review and is meeting-ready, HSO staff will assign the form to the next available IRB meeting with appropriate space, expertise and quorum. Meeting ready means the study appears to meet standard expectations of completeness for convened board review.   

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 identify any issues that might need to be addressed and develop recommendations. 

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. 

The principal investigator is notified of the results of the meeting via HawkIRB or e-mail. The form may be approved if there are no required changes, approved pending required changes, or tabled. After the principal investigator responds to the issues or revisions required by the full board, the form is then approved and the investigator is notified of approval via HawkIRB. For studies that are tabled, they must be rescheduled to an IRB meeting after addressing concerns identified by the initial convened board.

For a complete description of IRB procedures, please refer to the UI Standard Operating Procedures and Researcher Guide.

The IRB review process is captured on this flowchart.  For a complete description of IRB procedures, please refer to the UI IRB Standard Operating Procedures and Researcher Guide.

There are four constituted 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, Good Clinical Practice (GCP) as adopted by the FDA.  IRB-03 also reviews and approves research in compliance with Department of Veteran Affairs, Veterans Health Administration Handbook 1200.05.  The Statement of Compliance can be used as documentation of the institutional compliance standards in place for the University of Iowa Human Research Protection Program.  

There are human subjects protections training requirements in the Collaborative Institutional Training Initiative (CITI) Program for submission to each of the three IRBs.  See: Training Requirements to Conduct Human Subjects Research and the CITI User’s Guide.

Biomedical research investigates biological processes and causes of disease. It is typically conducted to increase scientific knowledge, expand understanding and verify hypotheses regarding the biology, causes, treatment, control and prevention of physical and mental diseases or impairments afflicting humans. 

Researchers from the following typically submit HawkIRB applications to IRB-01:

• College of Dentistry
• Carver College of Medicine
• College of Nursing
• College of Pharmacy
• College of Public Health
• University of Iowa Health Care  

IRB-01 is the only designated Privacy Board at the University of Iowa. Research involving any of the following require IRB-01 (biomedical) review: 

• Patients at the University of Iowa Health Care (UIHC) or a UIHC Hybrid Covered Entity OR
• Access to, creation, or use of any protected health information about the subject that is maintained in the records of UI Health Care or a UIHC Hybrid Covered Entity.

Also submit to IRB-01 if the research involves: 

• Physical or physiological (clinical/medical) intervention(s) that are greater than minimal risk
• Investigational New Drug (IND) application or exemption
• Non-Significant Risk Device (NSR) Determination
• Investigational Device Exemptions (IDE)
• Specimen or blood collection 
• Clinical assessments or other medical procedure(s)

The IRB reserves the right to request a change in IRB designation if appropriate IRB expertise is not available or to collect additional information about the study.

Additional information available on the IRB-01 page:

• 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

Social/behavioral/educational research (SBER) is the study of human behaviors and interactions, as individuals, communities, and societies. This type of research uses both qualitative and quantitative methods to understand evolving human systems. Social science researchers gather, interpret, and analyze information for a variety of social, economic, educational, and political purposes. 

Researchers from the following typically submit HawkIRB applications to IRB-02:

• College of Education
• College of Engineering
• College of Law, 
• College of Liberal Arts and Sciences 
• Tippie College of Business 

Researchers in these colleges should submit to IRB-01 if the research involves any of the activities listed above under IRB-01 (Biomedical) 

The IRB reserves the right to request a change in IRB designation if appropriate IRB expertise is not available or to collect additional information about the study. 

Additional information on the IRB-02 page:

• 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 reviews human subjects research projects involving VAHCS patients or their data, VA resources, staff, or conducted on VA premises. Please refer to the VA Investigators Guide for a complete description of VA IRB-03 procedures.

Additional information on the IRB-03 page:

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

IRB-04 reviews the following human subjects research projects:

• The research is funded by a Department of Defense (DoD) component, or
• The research involves cooperation, collaboration, or other type of agreement with a component of the DoD or its personnel, or
• The research uses DoD resources, including its equipment, property, facilities, assets, or identifiable data or specimens from living individuals, or
• The subject population will intentionally include personnel (military and/or civilian) from a component of the DoD. 

The investigator may choose to submit DoD funded projects to a commercial IRB for review and approval.

Additional information on the IRB-04 page:

• the full board meeting schedule,
• roster of current IRB-04 members,
• name and contact information of the IRB-04 chair