Informed Consent Document(s)

The following sections of the UI/WCG consent template include required UI language which cannot be modified in any way:

• Authorization to Use and Disclose Information for Research Purposes
  AND
• Compensation for Injury

Be sure to always download the consent template from the Attachments Page in HawkIRB to ensure you are using the most current version. 

Record of Consent

Please review the Record of Consent FAQs or the UI Investigator’s Guide for more information on when the documentation of research participation in a research subject’s medical record, via the EPIC Research tab, must be used.

A contact person(s) from the research team must be listed in the ROC section in the HawkIRB application. This should be someone who can be contacted any time. The project information must be detailed in this section of the HawkIRB application, including details about the study drug, potential complications, and/or any other important information. The UIHC no longer requires the use of G-12s for studies including drugs not approved by the FDA (or not being used for the approved indication, age range, etc.). Please ensure the ROC section in the application is detailed to include all common and severe complications of the study drug.

The Record of Consent (ROC) section in HawkIRB is only reviewed by the Human Subjects Office; it should not be sent to WCG.  If the University of Iowa Health Care policy IM-MR-06.21 titled “Documentation of patient participation as a subject in a research protocol or use of an investigational medication, study medication, investigational device, or biologic” conditions apply to the conduct of the research, the study team should select either “does meet” or “do not meet.”  If selecting either of these options, include required template language in the HIPAA section of the Informed Consent Document.