Welcome
The Human Subjects Office (HSO) was established by the Vice President for Research to provide administrative support for the University of Iowa Institutional Review Boards. An Institutional Review Board is a group of individuals charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations. The University of Iowa has two such review boards, each consisting of faculty, staff, and representatives from the Iowa City community.
Mission
The mission of the University of Iowa Institutional Review Boards is to assure that the rights and welfare of human subjects are adequately protected in research.
News
November 2009
NEW! WIRB is now electronic! Please review the WIRB webpage here for more information.
October 2009
Revisions to the Cash Handling Policy 10/29/09 - UI Accounting Services has implemented changes to the Cash Handling policy to address questions that have come from the Research Community. The policy changes are reflected at http://www.uiowa.edu/~cashhand/policies.html under the sections “Policy Statement”-first paragraph, “Who Should Know This Policy”-first paragraph, and a new section at the bottom of the page. The procedure/template required to be completed and returned per the instructions on page 2 is at http://www.uiowa.edu/~cashhand/forms.html, bottom of the page, hyperlink “Research Subject Compensation template”.
Effective Immediately - In accordance with a directive from the University of Iowa Office of Internal Audit, all NEW HawkIRB research projects submitted 10/1/09 or later that includes a form of research subject compensation using cash, check, or cash equivalent (Cash or cash equivalent is defined as coin, currency, checks, money orders, credit cards, accounts receivable charges, electronic funds transfers, tokens, gift cards, parking tickets and/or stamps) will now require documentation of an University of Iowa Accounting Services approval of a cash handling policy. It will be a required document which can be attached to the attachments page of the New HawkIRB application prior to submission and review by the Human Subjects Office. Please follow this link for additional information.
August 2009
NEW! The Record of Consent can now be used on WIRB studies! View here for more information!
NEW! The Human Subjects Office is happy to announce the launch of the new Community Based Research (CBR) process here!
July 2009
NEW! WIRB Form A and Form B forms have been revised to include the UIHC Billing Compliance Office. See the WIRB page on the HSO Website for more information by going here.
May 2009
IRB News Mailing List and IRB Advisor - New!
NEW! An IRB List Serve and access to IRB Advisor! This mailing will be used to send a monthly IRB Advisor newsletter, as well as, communicate other announcements, education materials, and news! IRB Advisor is a publication of AHC Media. This monthly newsletter contains articles on issues facing IRBs and human subjects researchers. To find out more, click here.
April 2009
PLEASE NOTE: There has been a revised Guide for Human Subjects Research and UI IRB SOP added to the HSO website. A tracked changes version of both have been added for your review by clicking here. You can also access the new Guide for Human Subjects Research and the SOP by clicking on the link in the column on the left.
March 2009
Effective April 1st 2009, for all Full Board Biomedical (IRB01) and studies conducted at the Iowa City VAMC (IRB03), the IRB will be requiring a response to the full board meeting minutes within 14 calendar days of receipt of the minutes for studies "approved pending required actions," and 21 days for studies that are "tabled". If a response is not routed back to HSO within the above noted time limits, the application form in progress will be withdrawn from workflow. This means that the application will undergo no further processing, and must be completed and resubmitted in order to be reviewed by the IRB. This policy change is in response to HSOIRB being requested to reduce the processing time an application remains in workflow. As future changes occur, notifications will be either posted on the HSO website or sent out via email.
NEW for VA Researchers! Information related to the review of the VA Information Security Officer is now available on the HSO website by looking here. Coming soon will be the VA Privacy Officer Checklist and the VA Investigator Handbook created by the VA Research Compliance Officer.
NEW!! The Powerpoint presentation given for the biomedical research community on March 4, 2009 is now available for review. The title of this Educational presentation was Understanding Research Data Security: for Biomedical Researchers and was presented by Jason Alexander, Information Security Manager, for UIHC Healthcare Information Systems.
Please note! Effective March 2009. The WIRB informed consent template has been revised. The Compensation for Injury section of the UIWIRB informed consent document now has two options to choose from for use in this section. Please review the UIWIRB informed consent document on the WIRB page of this website for specific details.
NEWS! Updated 3/9/09
HawkIRB will be unavailable this evening, Monday March 9, 2009 from 7:00pm to 5:00am for database server maintenance. We apologize for any inconvenience this may cause.
The IRB-02 Data Security presentation scheduled for tomorrow (3/6/09) has been canceled due to low enrollment. We apologize for any inconvenience this may cause. If you have questions concerning data security, please contact the HSO at 335-6564.
January 2009
Updated 1/21/08: Please note the IRB-01 Full Board Continuing Review meeting has been canceled on 2/2/09. The appropriate number of IRB members needed to meet quorum could not be met. We apologize for any problems this may cause. All efforts possible will be made to place those studies submitted by the 1/22/09 deadline on Full Board meetings prior to the lapse date. If you have any questions, please contact the HSO.
Educational Sessions for Spring 2009
HawkIRB Training Sessions provide basic information about technical aspects of the HawkIRB system and guidance about content for specific sections and questions in the HawkIRB application. The purpose of these sessions is to assist investigators, delegates, and research team members to prepare complete and thorough IRB applications in order 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 guidance about proper completion of the forms. Separate training sessions are held for the New Project Application (an overview of the entire application) and Modification/Continuing Review/ Reportable Event Forms.
The IRB offers hour-long presentations on a variety of topics related to human subjects research. These presentations are open to all research team members, members of the university community, and the general public.
December 15, 2008
*** Attention Mac OS X.4 “Tiger” and OS X.5 “Leopard” users***
All Mac users: The Human Subjects Office has been receiving numerous calls related to .rtf documents and Mac users not able to view the IRB stamp or save .rtf files into HawkIRB. Please review the following fix related to .rtf format templates used in HawkIRB by clicking here. If you continue to have problems after using this suggested fix, please contact the Human Subjects Office.
December 1, 2008
UPDATE 10:27am: HawkIRB is back online and should be functioning properly. Thank you for your patience.
HawkIRB has been shut down and is not expected to be available until at least noon today. The report from UI ITS is that there was a disk failure last night – and they are in the process of replacing it, but it is causing some widespread slow downs across various databases (including HawkIRB). The HSO apologizes for any inconvenience this may cause. Please keep an eye on the website for any updated information. Thank you.
To view past news items, click here.