E. Institutional Biosafety Committee

The Institutional Biosafety Committee is responsible for ensuring that recombinant DNA activities comply with the National Institutes of Health (NIH) guidelines.  The Principal Investigator is required to submit a registration document to the Environmental Health and Safety Office for all recombinant DNA experiments that are not exempt from the NIH guidelines.  Institutional Biosafety Committee must review and approve the registration document prior to the initiation of the research.  The Institutional Biosafety Committee will not review projects involving gene therapy until after the NIH Recombinant DNA Advisory Committee (RAC) has completed or waived its review of the protocol.  The Institutional Biosafety Committee notifies the University of Iowa IRB of its approval of projects using recombinant DNA, but the Institutional Biosafety Committee does not share its deliberations with the University of Iowa IRB unless there are specific subject protection issues raised by the Institutional Biosafety Committee.  

The University of Iowa IRB allows concurrent review by the University of Iowa IRB and the Institutional Biosafety Committee and defers release of the study contingent upon receipt of Institutional Biosafety Committee approval.  If Institutional Biosafety Committee review identifies specific subject protection issues after University of Iowa IRB review has occurred, the University of Iowa IRB Chair reviews these issues.  If the Chair believes the suggested changes are appropriate and qualify as minor modifications, the University of Iowa IRB Chair reviews these through an expedited process.  If changes exceed minor modifications, the University of Iowa IRB Chair refers the application back to the full board for review prior to final approval.  IRB-01 retains protocols requiring Institutional Biosafety Committee for review; they are not sent to Western Institutional Review Board regardless of industry sponsorship.