Record of Consent Process Changes to Your Research Protocol

In coordination with the Unversity of Iowa Hospitals and Clinics (UIHC), the HawkIRB system will be updated to reflect the changes outlined in the update UIHC Policy “IM-MR-6.21 DOCUMENTATION OF PATIENT PARTICIPATION AS A SUBJECT IN A RESEARCH PROTOCOL OR USE OF AN INVESTIGATIONAL MEDICATION, STUDY MEDICATION, INVESTIGATIONAL DEVICE, OR BIOLOGIC” These changes will be effective in HawkIRB as of 2/12/18.  The update content of this policy specifies when and how human subjects that participate in research protocols need to be documented, particularly in the electronic medical record.  This documentation has traditionally occurred via a document called the Record of Consent.  Please stay tuned for additional information on the HSO website outlining how to update your HawkIRB application to incorporate these changes.