March 2009 - New Information!
The VAMC 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 - Amber Smith
Email: Amber.Smith2@va.gov
Privacy Officer Checklist
Iowa City VA Information Security Officer - Randy Smith
Email: Randall.Smith@va.gov
Information Security Officer Checklist
and Directions for Use
The VA RCO has also created a guide for VA Investigator's to review to provide overall guidance in conducting research at the Iowa City VAMC.
Iowa City VA Research Compliance Officer - Sara Miller
Email: Sara.Miller@va.gov
Investigator Guidelines Handbook
April 2008 - Please note! Any protocols that involve VAMC patients, records, or if any part of the protocol is conducted on VAMC premises, it will need to be moved from IRB-01 to IRB-03. A HawkIRB modification will need to be completed and submitted by June 2, 2008 making the change from IRB-01 to IRB-03. If your continuing review is due within two months of when you submit your modification, you may submit a combined Modification\Continuing Review. If VAMC resources are no longer used, a modification will be required to remove VAMC from the HawkIRB application.
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 1200.5.
IRB-03 meets just prior to the first IRB-01 Continuing Review meeting every month from 1:00-2:00 in 2114 MedLabs. Placement of new projects, modifications, continuing reviews, and reportable events will be reviewed at this meeting. There will be only one IRB-03 meeting a month. If you have questions regarding the IRB-03 meeting schedule, please email Nadine Miller at Nadine-miller@uiowa.edu.
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 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. Please see the IRB-03 meeting dates listed below.
IRB-03 Meeting dates for 2008
11/29/07 7/07/08
12/10/07 8/04/08
1/7/08 9/15/08
2/11/08 9/29/08
3/03/08 11/10/08
4/1408 12/08/08
5/1208
6/09/08
IRB-03 Meeting dates for 2009
1/12/09
2/9/09
3/9/09
4/6/09
5/4/09
6/1/09
7/13/09
8/10/09
9/9/09
10/5/09
11/2/09
12/14/09
Expedited Review Timeframe
For projects eligible for expedited review, please allow approximately four 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 four 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
Chairs of IRB-03
Andy Bertolatus, MD
340 CMAB
(319) 356-8225
Herbert Berger, MD
340 CMAB
(319) 356-8318
Catherine Woodman, MD
1E15 VA
(319)339-7186
