Introduction to the IRB and Human Subjects Office

  1.  What is an Institutional Review Board (IRB) and why is it necessary for research?
  2.  What is the purpose of each of the three University of Iowa IRBs and the external IRB? How can I determine which IRB should review my project?
  3.  What role does the Human Subjects Office play and how is it different than the IRB?
  4.  What is a Federal Wide Assurance (FWA)?

What is an Institutional Review Board (IRB) and why is it necessary for research?

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 human subjects regulations.  While the principal investigator has primary responsibility for the conduct of the study, the University of Iowa IRBs are responsible for protecting the rights and welfare of study participants.​ Before a research project involving human subjects is initiated, it must be reviewed and approved by an IRB.  

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, 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.​


What is the purpose of the University of Iowa IRBs and the external IRB?  How can I determine which IRB should review my project?​

The Office of the Vice President for Research at the University of Iowa has established three internal IRBs and has agreements with a number of external IRBs to review all human subjects research conducted by faculty, staff, or students of the University. These boards, the UI’s IRB-01, IRB-02, IRB-03, review projects in a wide range of medical, social, and behavioral fields.  ​

IRB-01: Biomedical research
IRB-02: Behavioral / Social Science research
IRB-03: VA Medical Center research
WIRB: Industry-sponsored AND industry initiated research


What role does the Human Subjects Office play and how is it different than the IRB?

The Human Subjects Office (HSO) is the administrative arm of the IRB.​ It is located in Office 105 of the Hardin Library for the Health Sciences and serves in several functions: 
  • To provide administrative support for three Institutional Review Boards 
  • To provide assistance to investigators who are preparing IRB applications 
  • To process applications as efficiently as possible 
  • To maintain records of IRB reviews and approvals 
  • To monitor ongoing human subjects research
  • To coordinate submissions to all external and commercial IRBs

While HSO staff assist investigators in understanding UI policy and procedures, all decisions regarding IRB approval are made by the IRB chair, chair designee, or full convened board.  

What is a Federalwide Assurance (FWA)?

An FWA is an assurance of compliance with Department of Health and Human Services (HHS) regulations pertaining to the protection of human subjects.  The federal Office for Human Research Protections (OHRP) requires that an institution have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) if the institution is engaged in human subjects research that is conducted or supported by any agency of the HHS.  The University is required to maintain this assurance because it receives federal funding for research involving human subjects.​