B. Relationship with Western Institutional Review Board

Western Institutional Review Board provides IRB review and oversight for research that meet all of the following conditions:

1. The study is sponsored or funded by the Department of the Navy
2. The project is a study that involves human subjects and is designed to evaluate prospectively the safety and/or effectiveness of new drugs or devices or behavioral interventions.
3. The protocol for the project was designed and written by the sponsor.
4. The sponsor holds all INDs/IDEs for the protocol.
5. The only sponsor of the research is a for-profit entity/company.
6. The University of Iowa investigator has not previously submitted the study to another University of Iowa IRB.

No transfers of projects already submitted to IRB-01 are allowed.

The project cannot involve any of the following:

1. Xenotransplantation
2. Embryonic stem cells
3. Review and approval by the University of Iowa Institutional Biosafety Committee (e.g. studies that involve recombinant DNA)
4. Any research funds from a federal or other not-for-profit funding source.
5. Research performed at the VAHCS and/or utilizing VAHCS resources, or performed by VAHCS employees or agents on VAHCS time.

Western Institutional Review Board is to perform all IRB functions in compliance with applicable federal and state regulations or laws in order to protect the rights and welfare of human subjects.  The University of Iowa coordinates application materials and coordinates other University of Iowa committee review prior to submission to Western Institutional Review Board for review.  By contract, Western Institutional Review Board notifies the University of Iowa Human Subjects Office of any Western Institutional Review Board termination or suspension of a study, instances of serious or continuing noncompliance, initiation of for-cause audits, targeted regulatory inspections or other matters that may impact the University of Iowa’s compliance with applicable regulations and laws governing human subjects research.  

The University of Iowa has the contractual right to withhold any protocol from Western Institutional Review Board review and keep it for review and oversight by IRB-01.  The University of Iowa may decide to retain a study if the protocol has significant local context issues such as a unique vulnerable population, involves an investigative team that has had previous serious and/or continuing noncompliance issues, or if the research design or intervention adds unusual risk for the subjects.  If investigators have questions about whether or not the protocol should be submitted to Western Institutional Review Board, please call the Human Subjects Office.