Research under the direction of the VAHCS, or research that involves VAHCS patients requires review and approval by IRB-03 and the VAHCS Research and Development Committee (R&D Committee). Completion of the University of Iowa IRB-03 review and associated IRB findings and actions is documented on a VA form 10-1223, an IRB approval letter, and IRB minutes for full board studies. This documentation is sent to the VAHCS research office and VA Principal Investigator.
The VAHCS R&D Committee does not share its deliberations with IRB-03 unless there are specific subject protection issues raised by the committee. Should such issues arise, the R&D Committee notifies the IRB in writing following its deliberations. If the IRB agrees that the issue(s) are related to subject protection, the IRB will require the Principal Investigator to revise the application to address the identified issue(s). The Principal Investigator notifies the R&D Committee when any study, including those involving investigational drugs, has been terminated. Once IRB-03 and the VAHCS R&D Committee have reviewed and approved the new research project, the Human Subjects Office releases the project to the Principal Investigator.