PILOT AND FEASIBILITY PROJECTS

 

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Requirements for Human Subjects Research

Before a research project involving human subjects is initiated, it must be reviewed and approved by an Institutional Review Board (IRB).

Guide for Human Subjects Research at the University of Iowa

If you are a UI student or faculty/staff and have questions about whether or not your project meets the definitions of research involving human subjects and requires IRB review, call the HSO office at (319) 335-6564 or send them an email at irb@uiowa.edu.

If you are a researcher outside of the University of Iowa and you have questions about whether or not your project meets the definitions of research involving human subjects which requires IRB approval and supervision, you must find an independent IRB to review your project to determine whether your project is exempt. If exempt, you will then get a letter from that IRB indicating that. You will need to submit that letter to GPCAH.

All projects involving human subjects must get IRB review - either for approval or exemption. A letter from the IRB indicating approval or exemption must be sent by the researcher to UI Division of Sponsored Programs before funds can be released.

UI Investigators, i.e. current student, staff or faculty at the University of Iowa:
Each UI investigator will need to complete a new HawkIRB application for his or her individual project. This application can be found at http://research.uiowa.edu/hso/. Any questions about the HawkIRB application, call the IRB office at 319-335-6564.

Non UI Investigators, i.e not currently affiliated with the University of Iowa as a student, faculty or staff:
Investigators outside of the University of Iowa will need to obtain IRB review and approval through their agency or institution or independent IRB review board and provide the Federal Assurance # (FWA) to the UI Division of Sponsored Programs, along with the IRB approval letter prior to beginning any work on the project. Through its Federalwide Assurance, (FWA) the IRB is held accountable to federal agencies that have established guidelines for the use of human subjects in research. Independent IRB's must be approved by NIH. A list of approved IRB 01 is available at http://ohrp.cit.nih.gov/search/asearch.asp#ASUR.

All investigators making an IRB application:
When you get to the funding questions, you should list as follows:

Funding Source: US Department of Health & Human Services, Center for Disease Control & Prevention with Wayne Sanderson as the Principal Investigator (PI) name on the grant.