An Institutional Review Board (IRB) is required by the Federal regulations 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 (45 CFR 46, 21 CFR 50, and 21 CFR 56). 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.​

ADDITIONAL RESOURCES:

• UI IRB Standard Operating Procedures and Researcher Guide, Section I, Part 1 (Introduction to the UI Human Research Protection Program).

Determining which IRB should review my project

The Office of the Vice President for Research at the University of Iowa has established four 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. IRB-01, IRB-02, IRB-03, and IRB-04 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.
• IRB-04: Department of Defense.
• External/Commercial IRBs.

ADDITIONAL RESOURCES:​

• UI IRB Standard Operating Procedures and Researcher Guide, Part I, Section 4 (University of Iowa Institutional Review Board).
• UI IRB Standard Operating Procedures and Researcher Guide, Part I, Section 5 (Use of External IRB Model).

Role of the Human Subjects Office (HSO)

The Human Subjects Office (HSO) is the administrative office of the IRB and the UI Human Research Protection Program.​ Located in Office 105A of the Hardin Library for the Health Sciences, the HSO serves several functions:

• Protection of human subjects rights and welfare.
• Addressing Conflict of Interest (COI) disclosure requirements.
• Addressing adherence to Clinical Trial registration and reporting requirements.
• Verifying completion of applicable training related to human subjects research protections for those involved in the conduct of human subjects research.
• Serves as a central hub for all other review and approval aspects of the Human Research Protection Program (HRPP).
• Provides educational assistance to investigators who are preparing IRB applications.
• Maintains institutional records of all IRB reviews and approvals.
• Conducts compliance monitoring of ongoing human subjects research.
• Coordinates submissions to all external and commercial IRBs.

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

The UI Federalwide Assurance (FWA) Document

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.​

ADDITIONAL RESOURCES:

• UI IRB Standard Operating Procedures and Researcher Guide, Section I, Part 4.B (Scope of IRB Review at the University of Iowa).
• UI Federalwide Assurance Document.
• Office for Human Research Protections (OHRP).