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.  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 as a separate IRB application.

VA Researcher Guide 

A 2024 VA Researcher Guide (both a tracked change and clean version) is available.  This guidance document includes a number of changes that include:

  • Update contacts for the following: VA HRPP Contact, VA Privacy Officer, VA COI Contact, VA Information Security Officer
  • Updates to the following processes 
    • NCI CIRB 
    • VA COI 
    • VA Clinicaltrials.gov registration and results reporting 
  • Removed sections not relevant to VA research 
  • Update VA reporting requirements to five days throughout the document
  • Update to reflect VA documentation requirements in the IRB-03 application and informed consent materials when research is occurring at both the VAHCS and the University of Iowa locations
  • Clarify expected information in the IRB application for inclusion of non Veterans

All research conducted under IRB-03 must also be compliant with VHA Handbook 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.  The VA HIPAA Authorization Form is included as part of the VA Informed Consent Document Template.  A VA HIPAA Authorization form is required, when applicable, as part of the informed consent process.

IRB-03 HawkIRB Guidance

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

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 System Security Officer (ISSO) - Merle Kelley 
Email: merle.kelley@va.gov

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

The VA Checklist (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.

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 Lori Fisher at lori.fisher4@va.gov.

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, x637666, IRB-03 Chair(s), the HSO Biomedical Full Board Manager, or the IRB Review Assistant Director.  

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.

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.

Click here to access IRB rosters for the current year. Contact the Human Subjects Office to request rosters prior to 2018.

Submit HawkIRB applications to both the UI IRB (IRB-01) and the Iowa City VA (IRB-03)

Investigators conducting research projects with activities at both the University of Iowa and Iowa City Veterans Administration Health Care System (VAHCS) will need to submit an IRB-03 application to describe the research that occurs at the VAHCS using IRB-03 and submit an IRB-01/02 application to describe the activity that will occur at the UI.  These activities can include anything from an intervention (blood draw, MRI/CT, etc.), interaction (survey, interview), or use of resources (staff, storage, equipment, office space) at either facility. The following are a couple of common scenarios to use as an example:  

  1. A clinical trial conducted at UI and the VA.  Study procedures will be performed at both sites, and subjects will be treated at the institution they are recruited from. There are other study sites besides the UI or VA, and neither UI or VA is the coordinating center.
    • You will submit an IRB-01 application to describe the study at the UI, and an IRB-03 application to describe the study at the VA.
      • The IRB-01 application will cover research activities at the University of Iowa, and
      • The IRB-03 application will cover research activities at the Iowa City VAHCS.
    • In section VII.A.2, indicate the project is a multisite study.   
      • Describe the roles of each participating sites in section VII.A.  
      • A coordinating center must be identified in a multisite study.  
  2. A clinical trial occurs both at UI and the VA.  Study procedures will be conducted at both sites, and subjects will be treated at the Institution they are recruited from.  The UI or the VA are the ONLY sites for the research, (or there are multiple sites and either the UI or the VA is the coordinating center),
    • Submit an IRB 01 application to describe the study conducted at the UI, and an IRB-03 application to describe the study conducted at the VA.
    • In section VII.A.2, indicate the study is a multisite study.
      • Either the UI site or the VA site will be named as the coordinating center in section VII.A as appropriate, and the other site not acting as a coordinating center will be listed as a clinical participating site.
    • Pay special attention to HawkIRB section X, to accurately describe where data is stored and how it is transferred to from the UI and the VA locations. 
  3. Study procedures are conducted almost entirely at the University of Iowa, and all subject activity takes place at the University of Iowa. However, because a resource of the of the VA is needed for the study (such as lab space or equipment), both the VA and the UI are engaged in research, and both an IRB-01 and an IRB-03 application will be submitted.
    • The IRB-01 application will describe all study procedures as they are conducted at the University of Iowa.
    • In section VII.A.2, indicate that this is a multisite study. 
      • In question VII.A.3, indicate the University of Iowa is the coordinating site.
      • Provide reasonable responses to the following questions regarding how research related communications will occur with all study locations.
      • Indicate that the Iowa City VA is a participating site. 
  4. The study procedures will occur at both the University of Iowa and the Iowa City VAHCS. Subjects may be identified at both sites, and all subjects will have procedures occur at both sites. For example, a study enrolls subjects at either site, the subjects will have a procedure conducted at UIHC, and also attend a workshop at the VA.
    • Two IRB applications must be created, IRB-01 to cover activities at UIHC, and IRB-03 to cover activities at the VA.
    • Subjects must be enrolled using the consent and (if applicable) HIPAA authorization specific to the institution they were recruited from, PRIOR to any PHI leaving that institution.
    • If the subject travels from one institution to the other, the subject must be consented using the receiving institutions consent in addition. Consider if a waiver of documentation of consent is allowable for this, to minimize the burden of an additional consent process on the subject.

If research is conducted at both the University of Iowa and the Iowa City VAHCS, with funding from the Veterans Administration, there will be a subcontract to the University of Iowa.  Indicate in the IRB-03 application that the research funding will be processed through the Iowa City VAHCS. To describe the subcontract to the University of Iowa, in the IRB-01/02 application, enter the funding  information as is accurate, in HawkIRB question III.1.

Only list research team members on the IRB-03 application who will be participating in research that occurs at the VA.  Only list research team members who will participating in research at the University of Iowa, on the IRB-01/02 application.  The research team of each IRB application do not have to be the same, because it is possible some team members may only be engaged in research at one site. Research team members may be listed on both IRB-01/02 and IRB-03 applications if they have the proper appointment or credentialing at each institution.

For further information on how to verify compliance with your VAHCS appointment while conducting research at the University of Iowa, consult with Kari Points  Kari.Points@va.gov.

HSO Contacts

Tony Quinlan, Assistant Director - IRB Review 
(319 335-9848
tony-quinlan@uiowa.edu

Kela (Kay) Lewis, Biomedical Focus Manager
(319) 467-1734
kela-lewis@uiowa.edu

IRB 03 Chairs 

Jeffery Meier, MD (IRB-03 Chair)
jeffery-meier@uiowa.edu

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

 

To reach the VA Research Office, please call 338-0581, extension 637666.

Iowa City VA Privacy Officer - Michele Myrvik
Email:  Michele.Myrvik@va.gov