IRB 01

Full Board Meeting Schedule​

IRB-01 meets every other Monday and every Thursdays at 2:00 p.m. Meetings may be canceled when there is insufficient board member availability, or if there aren't enough projects to review on a given meeting date.  If you have questions regarding the IRB-01 meeting schedule, please call the Human Subjects Office at 319-335-6564.

All new project applications requiring full board review are first screened in the Human Subjects Office. After the application has completed screening within the Human Subjects Office, there may be committees outside of the HSO that require review and approval prior to scheduling to a fully convened IRB meeting. For a listing of those committees, review the Other Committee page on the HSO website or the corresponding FAQ. Once a new project application prescreen process is complete, it is ready to be reviewed by the fully convened IRB-01 board. The new project is scheduled to the first available full board meeting. If the study requires special expertise (ie vulnerable populations, children, cognitively impaired, etc.) to be reviewed, the project may be scheduled to a later meeting. For projects that require full board review, please keep in mind that the Human Subjects Office makes a concerted effort to have expertise from every area at each IRB meeting. However, the HSO reserves the right to move a project to another meeting if a board member with that particular expertise is not available to provide a complete review of the application.

The screening process varies by type of application (Continuing Review, Modification, etc.), but typically involves both an administrative pre-screen to make sure the application is complete (e.g. consents are attached, funding source is correct, the grant is attached, etc.), and a content review for accuracy and consistency. If questions or concerns are identified by HSO staff, the project is returned to the PI through HawkIRB with instructions regarding how to address them. Once the PI has addressed the questions or concerns identified by the staff, the PI does need to route the project back to the HSO to continue application processing. If all of the questions have been answered, or the review is complete, the application can be scheduled to a meeting.

Please keep in mind that all studies scheduled to any IRB full board meetings require approximately ten days for preparation and distribution of meeting materials to the IRB members.

Continuing Review (CR) applications requiring full board review should be submitted to the IRB with sufficient time for screening and preparation for full board review. Please keep in mind during holiday seasons or during particular high traffic months, there is a possibility that a continuing review for a project could be moved to later scheduled IRB meeting date. Every effort will be made to schedule a project to be reviewed prior to its expiration date. Principal Investigator, delegates, and contact persons listed on the application will receive email notifications from HawkIRB when the research project is due for continuing review, starting 60 days in advance of the submission deadline. Do not ignore these messages. Please call the Human Subjects Office at 335-6564 if you have questions regarding these notices. See the Continuing Review FAQ for more information.

Once an application has been scheduled to a meeting, the investigator can see the meeting date in HawkIRB on the Project Summary page under History. In some cases, the IRB may request a PI to attend the meeting to answer questions. More frequently, an IRB member may contact the PI in advance of the meeting with questions about the study.

Meeting 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 any study that has required actions that are determined to be "approved pending" by the IRB full board, a response is required within 14 working days of receipt of the minutes.  For any study that has been tabled by the IRB full board, a response is required within 21 working days of receipt of the minutes.   

Expedited Review Timeframe

For projects eligible for expedited review, please allow at least three weeks for review and approval. The IRB chair determines whether a protocol is eligible for expedited review or meets the exempt category of review. Most minimal risk studies can be classified as expedited or exempt. If the study can be classified as expedited or exempt, the chair communicates directly with the Principal Investigator, generally via HawkIRB, regarding any issues or revisions that are required prior to approval. Depending on the complexity of the questions, the process may take longer than three weeks. Please see Chapter 4 of the UI Investigators Guide for more information about what type of studies may qualify for expedited review.

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.

Notice of IRB approval is sent to the Principal Investigator via HawkIRB.

Current and Past IRB membership

Click here to access IRB rosters for the current year. Email the Human Subjects Office to request rosters for previous years.

IRB Chairs

Andy Bertolatus, MD (Primary IRB Chair)
105 HLHS
319.384.4424
john-bertolatus@uiowa.edu

Dixie Ecklund, RN, MSN, MBA
105 HLHS
319.335.8446
dixie-ecklund@uiowa.edu

Bill McGinnis, MD
105 HLHS
(319) 768-3905
william-mcginnis@uiowa.edu

 

Douglas L. Somers, MD
105 HLHS
319.356.8252
douglas-somers@uiowa.edu

Catherine Woodman, MD (IRB-01 Expedited reviews)
105 HLHS 
(319)339-7186
catherine-woodman@uiowa.edu