IRB Review Steps

Research projects involving human subjects conducted by students and faculty from the University of Iowa require prior approval by the University of Iowa Institutional Review Board (IRB). The IRB is a group of individuals charged with reviewing and approving proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations. The University of Iowa has three review boards, each consisting of faculty, staff, and representatives from the Iowa City community.

International Programs and Academic Programs and Services cannot offer advice or assistance to students or faculty concerning the process. Additional information can be found at site at http://research.uiowa.edu/hso.

Students are advised to begin this process a minimum of six months to one year in advance. To get you started in the process, we offer a few basic guidelines.

IMPORTANT STEPS IN IRB REVIEW

1. Submit an online "Human Subjects Research Determination" form through HawkIRB. The IRB chair and/or their designees will determine if your study meets the definition of human subjects research. Federal regulations do not allow investigators to make this determination themselves. If a study does not qualify as human subjects research, Hawk IRB will issue a memo stating that the project does not require IRB review or approval. If a study does require approval, there will be several additional steps to follow.

2. Educate yourself in human subjects protections:

3. Develop all details for the conduct of the study including recruitment, consenting, and data collection documents/tools. Finalize all materials and obtain any additional agreements that may be necessary.

4. Create an IRB application using HawkIRB (access through the HSO web site at http://www.research.uiowa.edu/hso/)

5. Ask others to read your application, especially your consent. Your mentor/faculty advisor MUST read and agree with your application prior to submission to the IRB.

6. Submit your application through HawkIRB.

7. Respond to questions from the IRB review process through HawkIRB in a timely and thorough manner.

8. DO NOT begin your project until you have an APPROVAL LETTER and stamped, approved documents from the IRB. Simply responding to questions through HawkIRB does NOT mean you have approval to begin.

9. Once you have final approval, submit any changes via HawkIRB and obtain approval BEFORE implementing them.

10. Contact the IRB with questions or concerns. Additional information may be found on the Human Subjects Office web site at http://research.uiowa.edu/hso