G. Conflict of Interest in Research Committee

The Vice President for Research and Economic Development appoints the Conflict of Interest in Research Committee.  The Conflict of Interest in Research Committee is made up of faculty and staff representing the diversity of academic and research disciplines of the University of Iowa.  The Conflict of Interest in Research Committee reviews those cases in which an Investigator has disclosed a significant financial conflict of interest (see Definitions in Chapter XIX).  The Conflict of Interest in Research Committee recommends management strategies to the Vice President for Research and Economic Development.  

Management strategies are developed and implemented to address investigator financial interest and to assure that the Investigator may satisfy his/her research obligations in an objective manner and to avoid and/or mitigate concerns of bias as well as to protect the rights and welfare of research subjects.  Management strategies that may be considered in addressing conflicts range from no action required other than disclosure, to that of disqualification of the Investigator from participating in the project, as well as others.  Review of the study by the University of Iowa IRB is contingent upon University of Iowa IRB receipt and review of the Conflict of Interest in Research Committee management strategy once it is accepted and the conflicted investigator signs it.  The University of Iowa IRB has the authority to revise the management strategy if they determine it will increase protection for human subjects.  Any such revisions are communicated to the Associate Vice President for Research: Regulatory Affairs.  

When a conflict of interest is identified in an ongoing study, the IRB or IRB Chair will ask the Principal Investigator to halt enrollment voluntarily until a management plan has been reviewed and approved by the IRB.  If the Principal Investigator does not agree to voluntary halt of enrollment, the study goes to the next IRB meeting for consideration of suspension of study enrollment until the IRB reviews and approves a management plan.  It is a requirement that an investigator have a signed Conflict of Interest in Research Committee management plan prior to Western Institutional Review Board review.  No individual who holds a significant financial interest in a project may participate in the review of its management strategy.