New Exempt Application Live in HawkIRB (as of 1/27/22)

UI Investigator's Guide/IRB Standard Operating Procedures Updates

Changes to the Pharmacy & Therapeutics (P&T) Review Requirements - Retire use of G-12

New Exempt Application Live in HawkIRB (as of 1/27/22)

As you may be aware from Human Subjects Office(HSO)/IRB presentations the past few months and the January IRB Connection Newsletter, we have exciting news to announce!  The HawkIRB application now includes the new project Exempt submission form.  Thank you to all of the programmers, researchers, IRB members, IRB Chairs, and HSO staff who were involved in the development and testing of this new submission process.  Your contributions were extremely valuable in launching this new form!  The new exemption submission form has been considerably streamlined to facilitate a streamlined submission and review process for both the research community and the HSO/IRB.  The new project exempt submission can be accessed in the same manner as in past submissions.  To initiate a new project application in HawkIRB,

Select “New Project” from the HawkIRB inbox (top left hand corner).  Complete sections I-IV.1 as it relates to the conduct of the study.  In IV.1, selecting “Exempt Review” will open up the new Exempt form.  Complete the remaining sections as appropriate to the conduct of the study.  The Human Subjects Office will continue to have an Exemption Tool available if Principal Investigators and study teams are not certain if research could be reviewed and approved under an exemption category.  To access the Exemption Tool, see the IRB Educational Tools under the Education and Training section of the HSO website. 

Exempt Project Submission Requirements

All current draft IRB applications will automatically be converted to the new exemption form.  All projects that have been submitted to the IRB for review or are IRB approved will continue to be reviewed with the original Exempt application.  All IRB applications that are either pending IRB review or have current IRB approval will not be transitioned to the new exemption form.  If a study team wishes to utilize the new exemption form, the existing project will need to be closed or withdrawn.  A new project submission would be required.

Changes to the Exemption Post Approval Process

The HSO/IRB has also relaxed the post approval submission requirements for research approved under an exemption category of review.  Please review the new section in the UI Investigator’s Guide\IRB Standard Operating Procedures (Section I, Part 13 titled Modifications to an Exempt Application)

HawkIRB Training for Exempt Research

The HSO is continuing to offer live zoom training sessions during the Spring 2020 semester covering this revised process.  The HawkIRB training session provides an overview of the exempt New Project Application form including guidance to assist you in responding to the questions in the newly revised application for studies eligible for exempt status. Note:  This session will not provide an overview of the HawkIRB system and the IRB review process. We strongly recommend attending the New Project sessions before attending this session if you have never completed a New Project Application in HawkIRB.  This session will cover:

• Brief overview of the exempt categories defined in the federal regulations
• Revised Sections IV, V, VII.D, VII.E, VIII, X, and XII of the new Exempt form

Pre-registration is recommended. For complete information on the HawkIRB Application Training for Exempt Research, visit the Education and Training section of the HSO website under HawkIRB Training Sessions.

UI Investigator’s Guide\IRB Standard Operating Procedures Updates

The UI Investigator’s Guide\IRB Standard Operating Procedures posted on the HSO website has been updated.  A summary of changes for the 2022 (ver.1) guidance document can be found on the HSO website outlining the changes. A track change version and clean version are also available. These changes are outlined on the UI Investigator’s Guide\IRB Standard Operating Procedures page of the HSO website. 

Accessing the UI Investigator’s Guide\IRB Standard Operating Procedures

The  UI Investigator’s Guide\IRB Standard Operating Procedures can be accessed using your institutional log in with your UI HawkID@uiowa.edu log in and UI HawkID password.  You must either be logged into the University of Iowa Eduroam network, UI Healthcare network or if offsite, using the VPN Duo Mobile two factor authentication.  For questions regarding the 2022 updates, please contact the Human Subjects Office at irb@uiowa.edu or by calling (319) 335-6564.

Changes to the Pharmacy & Therapeutics (P&T) Review Requirements – Retire use of G-12

Effective Immediately, the G12 is no longer required for UIHC research studies utilizing an investigational drug.  The UI Health Care policy CM.P.24  Documentation of Patient Participation as a Subject in a Research Protocol or Use of an Investigational Medication, Study Medication, Investigational Device, or Biologic has been updated to remove the use of the G-12 document. A copy of the policy in its entirety can be found on The Point. 

As a result of the policy update, Principal Investigators (PI)s no longer need to submit or update G-12 documentation as part of their IRB applications on associated human subjects research protocols.  It is also no longer necessary to upload a copy of the G-12 documentation into the EPIC medical record.  PIs may delete the G-12 from their research protocols at their convenience by submitting a modification to the IRB.   

The Record of Consent (ROC) section in the IRB application will serve as a replacement to the G-12 document.  Any research protocols using an investigational medication, per the CM.P.24 policy, are required to select “does meet” on ROC.1 in the HawkIRB application.  It is very important to fully complete this section to provide detailed information covering

• key complications from the study drug(s) or study procedure(s)
• Other relevant information that may be important to clinical/emergency personnel

This is important so clinical care teams can be informed when providing clinical care to UIHC patients involved in this type of research.  The information in the ROC section of the HawkIRB application is automatically imported on the study team behalf to the EPIC Research Study Description section of EPIC upon IRB approval and release of the study.