IRB-03 VA Review

  1. I have an open, IRB-03 approved project, that describes research activity occurring at both the UI and VAHCS in the same HawkIRB form; do I have to do anything now? (beginning 2/15/16)
  2. How do I split an open IRB application into separate IRB-03 and IRB-01 applications? 
  3. I would like to obtain IRB approval for my new study that occurs at both the UI and the VA, what do I do?
  4. How do I handle funding from the VA for an IRB-01 application?
  5. What research team members do I list on each IRB-03 and IRB-01 applications?
  6. I am not sure that my VAHCS appointment type allows for me to work at UIHC.

I have an open, IRB-03 approved project, that describes research activity occurring at both the UI and VAHCS in the same HawkIRB form; do I have to do anything now?? (beginning 2/15/16)

You will not be required to change your HawkIRB application right away, but the transition must be made at or before the time your next continuing review form is due.  At the time HSO receives your IRB-03 continuing review, HSO staff will verify that this process has been initiated for your study, if not, we will return the continuing review form with instructions that you must split the HawkIRB application into separate IRB-01 and IRB-03 applications, including guidance on how to complete this process for your study.

How do I split an open IRB application into separate IRB-03 and IRB-01 applications?

The first step is to ensure that you have no pending forms under review for your IRB-03 project. If the IRB is reviewing any submission related to your research, you must wait until the review is complete. 

  • On the summary page of your approved IRB-03 project, you will see a link to “duplicate project” as an option for a form to create. Clicking that link will create a new project draft of your IRB 03 project, without an IRB number assigned. (note: This option will go away once you have used it) .
  • Edit this draft application to describe only the research occurring at University of Iowa, describing the collaboration with the Iowa City VAMC in section VII.A and HawkIRB question I.4  as necessary to provide a full picture of the research. 
  • Submit this Draft IRB-01 application for IRB review.  The IRB-01 study will be assigned an IRB number at this time.  
  • When you receive your IRB-01 approval notice, submit a modification to your IRB-03 project to remove research activity at the University of Iowa.  Below are tips on how to handle common research scenarios that involve both the University of Iowa and the Iowa City VA Hospital study sites.

I would like to obtain IRB approval for my new study that occurs at both the UI and the VA, what do I do?

Submit an IRB-03 application to describe the research that occurs at the VAHCS using IRB-03, and submit an IRB-01 application to describe the activity that will occur at the UI.  The following are a couple of common scenarios to use an example:  

  1. A clinical trial at conducted both the 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 activity at the University of Iowa, and
      • The IRB-03 application will cover research activity at the Iowa City VAMC.
    • In section VII.A.2, indicate the project is a multi site study.   
      • Describe the roles of each participating sites in section VII.A.  
      • A coordinating center must be identified in a multi site study.  
  2. A clinical trial occurs both the 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 as conducted at the VA.
  • In section VII.A.2, indicate the study is a multi site 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 participating clinical 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.
  1. 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 multi site 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. 
  1. 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.

How do I handle funding from the VA for an IRB-01 application?

If research is conducted at both the University of Iowa and the Iowa City VAMC, 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 VAMC. 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, and in question III.2, indicate that the agreement will be processed by Sponsored Programs - Federal/State/Local Agency Funded

What research team members do I list on each IRB-03 and IRB-01 applications?

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 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.

I am not sure that my VAHCS appointment type allows for me to work at UIHC.

For further information on how to verify compliance with your VAHCS appointment while conducting research at the University of Iowa, consult with Kari Steinkamp Kari.Steinkamp2@va.gov

I still can’t figure out how to do this.

Call or email:

Tony Quinlan, Sr. IRB Application Analyst  (319)335-9848 tony-quinlan@uiowa.edu