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.  As of February 15th 2016, the IRB-03 board will begin transitioning away from the review of research activity conducted at the University of Iowa.  This means 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.  Going forward, 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.  Individualized notifications will be sent to all affected IRB-03 researchers who conduct research at the Iowa City VAHCS. A "duplicate" feature has been added to the summary page of your IRB-03 project to easily duplicate the existing IRB-03 application contents over to an IRB-01 form.  This split must be in process at the time your next continuing review form is submitted or it will be requested by the Human Subjects Office. After this is approved, you will be instructed to remove description of activities occurring at the University of Iowa from your IRB-03 application via a modification to the IRB-03 project.  In addition, the next time you submit an IRB-03 modification, you will be asked to complete six new questions specifically related to VA research activities and subjects.  Ten existing questions have been removed from the IRB-03 form as they no longer apply to VA specific activities.  In the event you do not submit a modification prior to your next continuing review, you will be required to make these updates as part of the continuing review submission.    

For detailed information, attend the IRB Presentation on Friday, February 12, 2015.  Registration information and presentation details can be found here.  A copy of the presentation can also be found here.  The VA Research Office has also arranged for a repeat of this presentation in the Iowa City VAHCS on Wednesday, March 16th from 9:00-10:00am in room 3W101a in the Main Hospital.  Registration information and presentation details can be found here.  An FAQ has also been developed to answer the most common questions.      

October 19, 2015:  The VHA Administration has updated the contents of the VA HIPAA Authorization and VA HIPAA Revocation form.  Please review the information found here for more details.

Effective November 12, 2014, the VHA Handbook 1200.05 has been revised to VHA Handbook 1200.05.( http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3052)  All research conducted under IRB-03 must be compliant with 1200.05.  Additional information on the changes in 1200.05 can be found here (http://www.research.va.gov/pride/major_changes.pdf ) The VHA Research & Development office has issued a FAQ (http://www.research.va.gov/pride/120005.cfm).  for researchers and Research Offices over several policies found in 1200.05.

As a result of the changes in 1200.05, The VA HIPAA Authorization Form is now a separate document from the Informed Consent Document.  This VA HIPAA Authorization form will be required, when applicable, as part of the informed consent process.   The VA HIPAA Authorization form can be found on the 'Other Committee Review' page in the HawkIRB application.

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

The VAHCS mandates all research protocol submission be reviewed by the VA Privacy Officer and the VA Information Security Officer.  Below are checklists each of these individuals use as part of their review process.  If you have specific questions related to either of these checklists, please contact the Privacy Officer or Information Security Officer directly to discuss your questions or concerns.

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.

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 HIPAA Authorization form and 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

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