General Clinical Research Center


Obtaining Approval to Conduct a Study in the GCRC

All studies involving human subjects that are conducted in the GCRC must be approved by an Institutional Review Board (IRB) and the GCRC Advisory Committee (GAC) before initiation of the study.

Institutional Review Board.  The University of Iowa Institutional Review Board (IRB) for the Colleges of Medicine, Nursing, Pharmacy, Dentistry, and Public Health is known as IRB-01.Charged with protection of human subjects participating in research projects, this committee meets weekly to review the 700 new research projects a year and the 2500 continuing projects submitted annually.  Studies that are industry-initiated and industry-sponsored are sent to a commercial IRB, the Western Institutional Review Board (WIRB) for review.


Additional committees may need to review the study protocol.  The Human Subjects Office will forward the study protocol to the first two committees listed below; the investigator must send materials directly to the Nursing Research Committee.


GCRC Advisory Committee (GAC).  All studies conducted in the GCRC must also be approved by the GCRC Advisory Committee (GAC).  A member of the GCRC Advisory Committee reviews the protocol for scientific merit, safety, and utilization of GCRC resources.  If the investigator does not have peer-reviewed funding then an outside reviewer with expertise in the area of investigation will also review the protocol.  The full GAC committee then meets monthly to hear the reviews and approve protocols.  

 

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