The Role of the Institutional Review Board (IRB)  

An Institutional Review Board is a group of individuals charged with reviewing proposed research involving human subjects to protect those subjects and ensure compliance with federal regulations for the protection of human subjects (45 CFR 46).  The University of Iowa must designated one or more IRB(s) to review and approve human subjects research because the institution receives federal funding for research. 

While the principal investigator has primary responsibility for the conduct of the study, the UI IRBs are responsible for protecting the rights and welfare of study participants.​ All research projects involving human subjects must be reviewed and approved by an IRB before any research activity can be initiated.   

UI IRBs advise investigators, review all planned research involving human subjects, approve research that meets established criteria for protection of human subjects, and monitor approved research.   The IRBs also inform and assist the UI and its researchers on ethical and procedural issues related to the use of human subjects in research. IRBs facilitate compliance with relevant regulations of the United States Government and relevant state law, and provide a framework suitable for continued support by government agencies, private foundations, and industries for research involving human subjects at the University of Iowa.​  

UI IRB Policies and Procedures 

According to the federal regulations (45 CFR 46.108) the UI IRB must establish and follow written procedures for its operations. The UI policies and procedures are documented in the UI IRB Standard Operating Procedures (SOP) & Researcher Guide (also referred to as the Investigator’s Guide). To access the Guide, log in with  and your HawkID password. 

The Guide provides information about human subjects research policies, regulations and guidance for the conduct of research activities. It is available for use by investigators, research team members, IRB members, other UI committees and administrators and anyone else involved in the conduct of human subjects research. 

The University of Iowa IRBs and Other External IRBs  

The Office of the Vice President for Research at the University of Iowa has established 4 internal IRBs and has agreements with a number of external IRBs to review all human subjects research conducted by UI faculty, staff, trainees or students. These boards specialize in the review of projects in a wide range of medical, social, and behavioral fields.  ​ 

For information on which IRB applies, see Institutional Review Boards

  • IRB-01: Biomedical research 
  • IRB-02: Behavioral / Social Science research 
  • IRB-03: VA Medical Center research 
  • IRB-04: Department of Defense (not operational) 
  • Commercial: WCG and Advarra 
  • External IRBs  

The Role of the Human Subjects Office  

The Human Subjects Office (HSO) is the administrative office that supports the UI IRB’s.​ It is located in Office 105 of the Hardin Library for the Health Sciences and serves several functions:  

The Human Subjects Office responsibilities include: 

  1. Supporting the mission of the University of Iowa Institutional Review Boards to assure that the rights and welfare of human subjects are protected adequately in research.  
  2. Providing administrative support to the Conflict of Interest in Research Committee (CIRC). 
  3. Addressing adherence to Clinical Trial regulatory reporting and registration requirements. 
  4. Conducting Post Approval Compliance Monitoring of human subject’s research 
  5. Providing education and outreach for the programs under the HSO purview 
  6. Serving as the central hub for review and approval aspects of the Human Research Protection Program 

Staff in the Human Subjects Office maintain the following: 

  1. Files on all human subject’s research (including copies of all correspondence between the IRB, R&D, and investigators) that takes place at the University of Iowa  
  2. Electronic databases for tracking human subjects research studies, financial disclosures, 
  3. Conflict of Interest (COI) management plans, and CT.Gov registration 
  4. Minutes of full board IRB and CIRC meetings, COI management plans, and reporting 
  5. The institution’s Federalwide Assurance (FWA), the IRB and CIRC membership rosters, and a resume for each IRB or CIRC member 
  6. Institutional policies addressing federal regulations relating to human subjects research, COI, ClinicalTrials.Gov 

Additional responsibilities include, but are not limited to: 

  1. Preparing for and monitoring IRB meetings 
  2. Preparation of meeting minutes 
  3. Screening research applications for completeness prior to initiating the IRB review process 
  4. Acting as a resource for investigators on general regulatory information, guidance with forms, and assistance in preparing an application for IRB review 
  5. Providing staff support to the IRBs for all written correspondence 
  6. Sending notices of approval, study closure (other than closure of the study by the investigator) for externally sponsored projects to the University of Iowa DSP (formally known as the CTO) 
  7. Generating and sending reminder notices to investigators of upcoming continuing reviews 
  8. Providing education and outreach regarding the IRB process and regulations to the University community 
  9. Coordinating submission of application materials required by external Institutional Review Board(s) 
  10. Checking the short form consent process for compliance with regulatory requirements 

HSO staff provide guidance and assist investigators in compliance with federal regulations, UI policies and procedures. However, all decisions regarding IRB approval are made by the IRB Chair, Chair Designee, and/or full convened board.   

Additional Resources: