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The Institute for Clinical and Translational Science Research Protocol Review Committee reviews all protocols that propose to use the Clinical Research Unit. Each protocol is evaluated for scientific merit and utilization of CRU resources. Two reviewers also critique the protocols. This committee does not share its deliberations with the University of Iowa IRB unless there are specific subject protection issues raised. Should such issues arise, the CRU notifies the IRB-01 Chair in writing following its deliberations. If the Chair agrees that the issue(s) are related to subject protection, the Chair will require the Principal Investigator to submit a modification to address the identified issue(s).
It is not a requirement to obtain CRU Advisory Committee approval prior to final approval by the University of Iowa IRB. The CRU Program Executive Director or the Associate/Assistant Program Executive Director may not Chair the CRU. Individuals receiving salary support from the CRU grant shall not be voting members of the CRU. Members of the CRU are excused from the meeting if protocols they participate in are being discussed.