Research at the VAHCS

There are three IRBs at the University of Iowa.  All IRBs review and approve research in accordance with Department of Health and Human Services (DHHS) regulations at 45 CFR 46. In addition, for studies involving products regulated by the Food and Drug Administration (FDA), IRB-01 and IRB-03 comply with the requirements set forth in 21 CFR 11, 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812, and 21 CFR 814, Subpart H.  IRB-03 also reviews and approves research in compliance with Department of Veteran Affairs, Veterans Health Administration Handbook 1200.05.

The Iowa City VA Health Center System Principal Investigator Guide to be used in conjunction with upcoming changes to the IRB-03 review process.  Research studies involving both the Iowa City VAHCS and the University of Iowa will have to submit two separate IRB applications, in order for the correct IRB to review the activity at each location.  IRB-03 will review research activity that involves the VAHCS only.  Any research activity that involves the University of Iowa or UIHC, must be reviewed under IRB-01.     

An FAQ has also been developed to answer the most common questions about submitting an IRB-03 and IRB-01 application studies involving both the Iowa City VAHCS and the University of Iowa.      

Effective January 7, 2019, the VHA Handbook 1200.05 has been revised.  All research conducted under IRB-03 must be compliant with 1200.05.  The VHA Research & Development office has issued a Crosswalk Comparison of VHA Handbook 1200.05 (November 12, 2014) vs. VHA Directive 1200.05 (January 7, 2019) can be found here. ORD has additional Policies and Guidance Documents.

As of February 2019, The VA HIPAA Authorization Form is included as part of the Informed Consent Document.  This VA HIPAA Authorization form will be required, when applicable, as part of the informed consent process.   

VA Research Compliance Contacts

To reach the VA Research Office, please call 338-0581. From within the University, dial 158, extension 7666.

Iowa City VA Privacy Officer - Makenzie Johnson
Email:  Makenzie.Johnson@va.gov

Directions for Checklist for Reviewing Privacy, Confidentiality, and Information Security in Research Checklist: the checklist can be found in HawkIRB, in the Other Committee Review section, under VAHCS.  The VAHCS mandates all research protocol submission be reviewed by the VA Privacy Officer and the VA Information Security Officer.  If you have specific questions related to the use of this checklist, please contact the Privacy Officer or Information Security Officer directly to discuss your questions or concerns.

Iowa City VA Information Security Officer - Randy Smith 
Email:  Randall.Smith@va.gov

Iowa City VA Research Compliance Officer - Sara Miller 
Email:  Sara.Miller@va.gov

VA Related Forms

The VA Check list (Checklist for Reviewing Privacy, Confidentiality and Information Security in Research) can be found on the "Other Review: VAMC tab in the HawkIRB application.  VA Pharmacy & Therapeutics form can be found in the 'Other Review: VA: Pharmacy and Therapeutics (P&T)" tab.

IRB-03 HawkIRB Guidance

The Human Subjects Office has issued a HawkIRB Guidance Document to assist researchers with VA-specific questions in HawkIRB.

IRB-03 VA Full Board Meetings

There will be only one IRB-03 meeting a month due to the availability of the IRB-03 board membership.  If you have questions regarding the IRB-03 meeting schedule, please email Nadine Miller at Nadine-miller@uiowa.edu.

IRB-03 usually meets the second Monday of every month, those occasional dates are subject to change.  Contact the VA Research Office or HSO for specific questions on meeting dates and times.

**IRB meeting dates are based on the availability of the IRB-03 membership to maintain quorum.  Dates are subject to change or cancelation without prior notice.  Concerns regarding the IRB-03 meetings, IRB membership, or other VA related issues can be addressed to the VA Research Office at 319-338-0581, x7666, IRB-03 Chair(s), or the IRB Administrator.  

New project applications requiring full board review are placed on a meeting agenda after they have been accepted by the HSO staff review team. The review process begins when a project is received in the HSO through HawkIRB. The project is reviewed to ensure it is administratively complete (e.g. consents are attached, funding source is correct, the grant is attached, etc.). Next, the consent document(s) are reviewed and the entire application is reviewed for accuracy and consistency. If issues are identified by HSO staff, the project is returned to the PI through HawkIRB with questions and instructions for how to address the concerns. Once the PI has addressed the issues identified by the staff, the PI routes the project back to the HSO and, if the outstanding items have been addressed, it is accepted by the HSO and is scheduled to a meeting.

For modifications that require full board review, please allow  at least two-three weeks after receipt of the complete application to be placed on a meeting agenda.  This time is used for preliminary review, contacting the investigator with questions, and copying and distributing the materials about 10 days in advance of the meeting for board members' review.

For continuing review (and continuing review + modification) applications requiring full board review, will need to be submitted at least 30-45 days in advance of the lapse date of the project. This will ensure for review time in the HSO, distribution of materials to the IRB members, and completion of the minutes at the conclusion of the meeting.  HawkIRB will also send email notification of when the application will need to be submitted by in order to avoid the project from lapsing.

Minutes are sent via HawkIRB, generally within a week of the meeting, to the Principal Investigator, delegates, and contact persons listed on the application.

IRB-03 VA Expedited Review

For projects eligible for expedited review, please allow approximately one-two weeks for review and approval.  If the chair has questions about the project, the investigator will be contacted by HawkIRB, phone or by e-mail.  Depending on the complexity of the questions, the process may take longer than one-two weeks.

A similar timeframe should be allowed for projects that are classified as exempt from the regulations, since the chair may have questions for the investigator before the exempt determination can be made.

Current IRB Membership

Membership Rosters are available upon request by contacting irb@uiowa.edu.

Catherine Woodman, MD (Primary IRB-03 Chair)
1E15 VA
(319) 339-7186
catherine-woodman@uiowa.edu

Lois Geist, MD (IRB-03 Chair)
230 CMAB
(319) 335-8067
lois-geist@uiowa.edu