Institutional Review Boards & Human Subjects Office

October 2008

The SOP has been revised on the HSO website.  Please see the new version and a track changes version.   

News! HawkIRB will be unavailable on Saturday morning (October 11th) from 4:30am-5:30am for database service maintenance.  We apologize for any inconvenience this may have caused you.

Updated Investigator's Guide 8/1/08.

The Human Subjects Office was deemed a non essential unit during the flooding of Iowa City/Coralville. As a result, the office was closed the week of June 9-13. The HSO has resumed relatively normal business hours. We ask for your patience during this time to allow HSO staff to catch up from the downtime. We apologize for any inconvenience this may cause. Please contact the Human Subjects Office at 335-6564 if you have any questions. Thank you.

Notice of session rescheduling for IRB Policy issues:

The Human Subjects Office will be offering three educational sessions beginning on July 1, 2008 to reflect new IRB policy issues that will be effective August 1, 2008.  Please look here for additional information and how to sign up for these sessions.  Seating is limited.

As discussed in the Policy Change Educational Sessions, here is a clean copy of the UI Investigator's guide incorporating the new procedures for researchers.  If you prefer to view the revisions, here is a track changes version.  Also to the left of this information under "UI Investigator's Guide" is the newly revised version.  HawkIRB will now include NEW templated documents for the Record of Informed Consent and various recruitment material examples for researchers.  The informed consent document template will also have changes incorporated when it is downloaded from the HawkIRB attachments page.  These template revisions were included in the items that were reviewed at the Policy Change Educational Sessions earlier this month.  Copies of this handout are available here.  If you have any questions related to the new policy changes, please call the Human Subjects Office at 335-6564. 
 

Check the links below for dates and times for sessions that were held in Fall 2008..

To register for a session, send your name, department, the date and time of the class you would like to attend, and your e-mail address to: irb@uiowa.edu.

HawkIRB Training Sessions
These sessions will provide basic information about technical aspects of the HawkIRB system and guidance about content. The purpose of these sessions is to assist investigators, delegates, and research team members with preparing complete and thorough applications to the IRB to minimize the need for questions between the HSO/IRB and the investigator which can delay the review of the project. These sessions are for anyone preparing to submit a HawkIRB application for the first time and for those who would like an overview and guidance about proper completion of the forms.

Office Hours
Struggling with your application in HawkIRB?  Come to our office hours with your questions!  HSO staff will be available to answer questions you may have about your application and the IRB application process.

Presentations
Attend an HSO Presentation to learn the IRB basics, or to get more information on special topics!

The Human Subjects Office currently has a job opportunity available.  For more information or to apply please review the Program Assistant position under requisition #55902 on the JOBS@UIOWA.edu website or by accessing the information here.  The University of Iowa is an Equal Opportunity/Affirmative Action employer.  Women and minorities are encourage to apply.  As of 8/25/08, resumes are no longer being accepted.     

Please note!  Effective Monday, July 14, 2008. 

The WIRB informed consent template has been revised.  The UI Human Subjects Office/IRB/CTO and WIRB have agreed to remove the word "proven" from our informed consent template under the research related injury section.  This reflects ongoing concerns from our study sponsors with regard to the use of the word "proven" in our currently approved template for research related injury.  Please call the Human Subjects Office at 335-6564 if you have questions. 

**Updated June 27, 2008**

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.

In light of the current flooding situation on the UI campus, IRB/HSO policy change presentations and educational sessions scheduled for the week of June 16 have been postponed until further notice.  This includes the following:

Monday, June 16, 2008 - Policy Change Presentation 

Tuesday, June 17, 2008 - IRB-01 Continuing Review/Modification HawkIRB Training Session

Thursday, June 19, 2008 - IRB-02 Continuing Review/Modification HawkIRB Training Session

Friday, June 20, 2008 - HSO Office Hours

The Human Subjects Office advises to take the following actions in preparation for a possible outage of HawkIRB:

1. Print your currently approved application in HawkIRB (Instructions: Log into HawkIRB - Click on the IRB number under Projects - Under History, click on the most recent New or Mod form - Click on View a printer friendly version of this form).

2. Print all of your consent and recruitment attachments.

3. Look at the expiration date of your project.  If you haven't already submitted a continuing review, and your project will expire before the end of July, take note.  Federal regulations will still apply, even if HawkIRB is down.  If HawkIRB is down for an extended period of time, we may need to implement alternate procedures for conducting continuing reviews of applications approaching expiration.  If this occurs, it will be helpful for you to have a printed copy of your current application and other materials as described in 1 & 2 above.

Please email irb@uiowa.edu with any questions or call 335-6564.  Response to phone calls, e-mails, etc. may be delayed depending on the ability of the staff to access the HSO office. 

April, 2008

The IRB-02 open forum session for Monday, 4/14 Resources for How to Conduct Human Subjects Research is being cancelled due to lack of interest.

February 2008

There will not be an IRB-01 meeting on 3/20/08 during the week of Spring Break.  We apologize for any inconvenience this may cause. 

January 2008 

The Human Subjects Office will be closed on Wednesday, January 23rd and Friday, January 25th to allow all staff to attend an HSO staff retreat. Thank you for your patience during this time. We apologize for any inconvenience this may cause.

Spring 2008 Educational Sessions have been scheduled for IRB-01, IRB-02, and IRB-03.  Please click here for additional information.  Be sure to scroll down to the bottom of the page to view all available sessions.    

WIRB investigators please note!  Marty Barrows, WIRB coordinator, is out of the office until 1/14/08.  A 24-hour turnaround can not be guaranteed during this time.  There will be individuals from The Human Subjects Office assisting in the coordinator's absence.   

Welcome!  The Human Subjects Office would like to welcome several new staff members to our office.  Tony Quinlan and Cathy Rost are the newest additions to our staff.  They are both Sr. Application Analysts and will be working with IRB-01.  Welcome!   

November, 2007

The new IRB-03 for the VA is live as of November 19, 2007.  Click here for additional information relating to the IRB-03 review process and Full Board scheduling.  Here is a current roster of the IRB-03 members.  Please note the UI SOP has been updated to include the addition of the IRB-03 VA. 

HAWKIRB DOWNTIME! HawkIRB will be down on Friday, November 16, 2007 from 10:30pm to 6:00am. The IRB-03 VA rollout will be incorporated into HawkIRB during this time.  Please do not make any edits during this period, as they will will not be saved.  We apologize for any inconvenience this may cause.  Please contact the Human Subjects Office during normal business hours at 335-6564 with questions.

HAWKIRB TRAINING ALERT! To all faculty, staff and students who are conducting or who plan to conduct human subject research in the biomedical sciences (College of Dentistry, Medicine, Nursing, Pharmacy, Public Health and the Department of Speech Pathology and Audiology)The UI Institutional Review Board (IRB) and the Human Subjects Office (HSO) invite you to attend an educational session on Friday, November 9th; Wednesday, November 14th; Thursday, November 15th; or Friday, November 16th to introduce revisions coming soon in HawkIRB. Some of the changes were requested by our accreditors, (Association for the Accreditation of Human Research Protection Programs, Inc.). Other changes are being made to clarify questions to ensure that the IRB receives appropriate responses to facilitate the application review process. There are also required changes for those conducting VA research. Please call the Human Subjects Office at 335-6564 or email to irb@uiowa.edu if you are interested in attending. Seating is limited.

The IRB-01 meeting that is normally held on 11/22/07 has been cancelled due to the University Holiday.  The next scheduled IRB-01 meeting after the University holiday will be held on 11/29/07.  Please call the HSO at 335-6564 if you have scheduling questions. 

October, 2007 

Please note!  Effective October 2007  The UI WIRB Coordinator will be out of the office from October 15-October 29.  The 24-hour turnaround can not be guaranteed during this timeframe.  There will be individuals from the Human Subjects Office assisting in the coordinators absence.  Please call The Human Subjects Office at 335-6564 if you have questions. 

The IRB Full Board meeting for Thursday, October 11th, 2007 has been cancelled due to IRB member staffing.  The next scheduled IRB Full Board meeting will be on Thursday, October 18th, 2007.  We apologize for any inconvenience this may cause. 

 August, 2007

Beginning August 1, 2007: New Project Applications will not be accepted without a signed Assurance Document (signature page) attached to the HawkIRB application. A new attachment category at the bottom of the Consent Forms & Other Attachments page will be available on this date with instructions for scanning and attaching the signed document prior to submission. This will be required ONLY on New Project Applications submitted on or after August 1. Please review the Investigator's Guide located on the Human Subjects Office website for guidance regarding the signature page procedures.